It may be uncomfortable at first, but doing exercises to strengthen your quadriceps after you've had knee replacement surgery due to osteoarthritis is critical to your recovery. In fact, it can boost the function of your new knee to nearly that of a healthy adult your age.
That's the finding of a University of Delaware study published in the February issue of Arthritis Care & Research.
The authors include Lynn Snyder-Mackler, Alumni Distinguished Professor of Physical Therapy at the University of Delaware, Stephanie Petterson, clinical faculty at Columbia University, Ryan Mizner, an assistant professor at Eastern Washington University, Jennifer Stevens, an assistant professor at the University of Colorado at Denver, and Drs. Leo Raisis, Alex Bodenstab, and William Newcomb of First State Orthopaedics in Newark, Delaware.
"It sounds logical that exercises to strengthen your knee should be a component of your post-operative physical therapy after a total knee replacement, but it's not the convention at all," says Snyder-Mackler.
"There are all of these old wives' tales that strength training is a detriment to the patient and that the new knee should be treated delicately," Snyder-Mackler notes. "Our study demonstrates that intensive strength exercise as outpatient therapy is critical to begin three to four weeks after surgery."
Nearly 500,000 knee replacements, also known as total knee arthroplasties, are performed every year in the United States to treat severe knee osteoarthritis, the loss of the cushiony cartilage padding the knee. The joint disease leaves its sufferers with persistent pain and limited function, resulting in an overall diminished quality of life.
While knee replacement alleviates the pain of osteoarthritis and improves function, patients exhibit impaired quadriceps strength and function for such activities as walking and climbing stairs, and the levels remain below those of healthy people of the same age.
In a randomized controlled trial at the University of Delaware's Physical Therapy Clinic conducted between 2000 and 2005, 200 patients who had undergone knee replacements were given six weeks of progressive strength training two or three times a week starting four weeks after surgery. Half of the group also received neuromuscular electrical stimulation (NMES).
Their function was compared to that of 41 patients who received conventional rehabilitation and home physical therapy. Quadriceps strength, knee range of motion, and gait were measured in such tests as timed up and go, stair climbing and a six-minute walk.
The group in the progressive strength-training program showed significant improvement in quadriceps strength and functional performance. They also demonstrated substantially greater quadriceps strength and functional performance after 12 months than the group that underwent conventional rehabilitation.
"This study clearly demonstrates the importance of surgeons encouraging their patients to be compliant with progressive quadriceps strengthening during their rehabilitation to enhance their clinical improvement and function post-total knee replacement," notes Dr. Leo Raisis, a total joint surgeon and adjunct associate professor at the University of Delaware.
"Why undergo a $25,000 elective surgery and then not do as much as you can to get the most out of it and improve your quality of life?" Snyder-Mackler says. "Older people are incredibly motivated - they hurt after the surgery and they want to be better. They need to do this."
Source: Andrea Boyle
University of Delaware
среда, 18 мая 2011 г.
New Understanding Of COX-1 And COX-2 Enzymes Could Revise Classification Of Pain Meds
COX-1 and COX-2 enzymes may be blocked by pain medications such as Advil and Vioxx in a more complex manner than was previously understood, a Queen's University study has found.
"The results of the study have potential implications for how we classify the commonly used anti-inflammatory and pain drugs for aches, pains, and fever," says Colin Funk, a professor of Biochemistry and Physiology at Queen's and Canada Research Chair in Molecular, Cellular and Physiologiocal Medicine.
Published on-line in Nature Medicine, the study was conducted in collaboration with University of Pennsylvania researchers.
The study was initiated to explore the biochemistry associated with COX-2 inhibitors such as Vioxx, Bextra and Celebrex, which are now associated with an increased incidence of heart attack and stroke. Researchers looked at mice that were genetically modified so that their COX-2 was inhibited - to create a physiology in mice that roughly mimics that of users of COX-2 inhibitors. They found that the COX-1 enzymes in the mice "hooked up" in an unanticipated way with their remaining COX-2 enzymes creating what is called a new heterodimer.
Dr. Funk's co-researcher, Queen's biochemist Robert Campbell, has developed a computer model to show how the COX-1/COX-2 molecules can associate.
"It's possible the COX-2 inhibitor medications may affect the resulting new enzyme which is a mix of COX-1 and COX-2," says Dr. Funk.
This effect is being further explored by scientists and may lead to a broadened understanding of the biochemistry of common pain medications. It is now pointing toward possible alternatives to drugs like Vioxx and Celebrex, says Dr. Funk.
A study published April 13 by The Journal of Clinical Investigation (JCI) by the same research team found that new types of anti-inflammatory drugs may reduce COX-2 cardiovascular problems. That study was conducted after this one and incorporated the genetically modified mice created in this study.
The JCI study found a drug target that might substitute for COX-2: an enzyme called microsomal prostaglandin E synthase (mPGES)-1. The researchers showed that this drug did not predispose the animals to thrombosis or elevate blood pressure.
Sarah Withrow
withrowspost.queensu.ca
Queen's University
queensu.ca/
View drug information on Bextra; Vioxx.
"The results of the study have potential implications for how we classify the commonly used anti-inflammatory and pain drugs for aches, pains, and fever," says Colin Funk, a professor of Biochemistry and Physiology at Queen's and Canada Research Chair in Molecular, Cellular and Physiologiocal Medicine.
Published on-line in Nature Medicine, the study was conducted in collaboration with University of Pennsylvania researchers.
The study was initiated to explore the biochemistry associated with COX-2 inhibitors such as Vioxx, Bextra and Celebrex, which are now associated with an increased incidence of heart attack and stroke. Researchers looked at mice that were genetically modified so that their COX-2 was inhibited - to create a physiology in mice that roughly mimics that of users of COX-2 inhibitors. They found that the COX-1 enzymes in the mice "hooked up" in an unanticipated way with their remaining COX-2 enzymes creating what is called a new heterodimer.
Dr. Funk's co-researcher, Queen's biochemist Robert Campbell, has developed a computer model to show how the COX-1/COX-2 molecules can associate.
"It's possible the COX-2 inhibitor medications may affect the resulting new enzyme which is a mix of COX-1 and COX-2," says Dr. Funk.
This effect is being further explored by scientists and may lead to a broadened understanding of the biochemistry of common pain medications. It is now pointing toward possible alternatives to drugs like Vioxx and Celebrex, says Dr. Funk.
A study published April 13 by The Journal of Clinical Investigation (JCI) by the same research team found that new types of anti-inflammatory drugs may reduce COX-2 cardiovascular problems. That study was conducted after this one and incorporated the genetically modified mice created in this study.
The JCI study found a drug target that might substitute for COX-2: an enzyme called microsomal prostaglandin E synthase (mPGES)-1. The researchers showed that this drug did not predispose the animals to thrombosis or elevate blood pressure.
Sarah Withrow
withrowspost.queensu.ca
Queen's University
queensu.ca/
View drug information on Bextra; Vioxx.
POZEN Announces Positive Top Line Results For Its PN 400 Phase 3 Trials
POZEN Inc. (NASDAQ: POZN), today announced positive Phase 3 trial results for its PN 400 product candidate (enteric coated naproxen 500 mg and immediate release esomeprazole 20 mg) conducted by POZEN under an agreed Special Protocol Assessment with the FDA.
Both the PN 400-301/302 studies achieved the primary endpoints. Subjects taking PN 400 experienced statistically significantly fewer endoscopically confirmed gastric ulcers on PN 400 compared to subjects receiving enteric coated naproxen during the six-month period. In each of the trials, approximately 400 subjects received either PN 400 or enteric coated naproxen 500 mg, twice daily, over a six-month treatment period. Subjects underwent upper endoscopies at baseline and at one, three, and six months with the primary endpoint as the cumulative incidence of gastric ulcers. The FDA has recently informed POZEN that the appropriateness of this endpoint is the subject of an internal review and an FDA internal meeting is planned in Q1 2009 to discuss this matter.
POZEN and AstraZeneca entered into a co-development agreement for PN 400 in August 2006. PN 400 is an investigational product under clinical development in patients who require chronic non-steroidal anti-inflammation drug (NSAID) treatment for arthritis pain, such as osteoarthritis and who are at risk for developing NSAID-associated gastric ulcers. The NDA submission is planned for mid-2009. Full results of the PN 400 Phase 3 studies will be published in a timely manner.
Osteoarthritis is one of the most frequent causes of physical disability among adults. An estimated 46 million adults in the U.S. have physician diagnosed arthritis, accounting for 21 percent of the U.S. adult population, and two thirds of the people that have doctor-diagnosed arthritis are under the age of 65. Fifty percent of people on chronic NSAID's are at risk for developing NSAID-associated gastric ulcers.
About POZEN
POZEN is a pharmaceutical company committed to developing therapeutic advancements for diseases with unmet medical needs where it can improve efficacy, safety, and/or patient convenience. POZEN's efforts are focused primarily on the development of pharmaceutical products for the treatment of acute and chronic pain and other pain-related conditions. POZEN has development and commercialization alliances with GlaxoSmithKline for Treximet®, which was approved by the United States Food and Drug Administration for the acute treatment of migraine attacks; and with AstraZeneca for proprietary fixed dose combinations of naproxen with the proton pump inhibitor esomeprazole magnesium in a single tablet for conditions such as osteoarthritis and rheumatoid arthritis in patients who are at risk for developing NSAID-associated gastric ulcers. The company's common stock is traded on The Nasdaq Stock Market under the symbol "POZN". For detailed company information, including copies of this and other press releases, see POZEN's website: pozen.
Statements included in this press release that are not historical in nature are "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management's current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our failure to successfully commercialize our product candidates; costs and delays in the development and/or FDA approval of our product candidates, including as a result of the need to conduct additional studies, or the failure to obtain such approval of our product candidates, including as a result of changes in regulatory standards or the regulatory environment during the development period of any of our product candidates, such as the current uncertainty regarding primary clinical endpoints for our PN and PA programs; uncertainties in clinical trial results or the timing of such trials, resulting in, among other things, an extension in the period over which we recognize deferred revenue or our failure to achieve milestones that would have provided us with revenue; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products, including our dependence on GlaxoSmithKline for the sales and marketing of Treximet; competitive factors, including the potential introduction of competing generic products; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; our inability to obtain any additional required financing; technological changes; government regulation; changes in industry practice; and one-time events, including those discussed herein and in our Quarterly Report on Form 10-Q for the period ended September 30, 2008. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.
POZEN Inc.
Both the PN 400-301/302 studies achieved the primary endpoints. Subjects taking PN 400 experienced statistically significantly fewer endoscopically confirmed gastric ulcers on PN 400 compared to subjects receiving enteric coated naproxen during the six-month period. In each of the trials, approximately 400 subjects received either PN 400 or enteric coated naproxen 500 mg, twice daily, over a six-month treatment period. Subjects underwent upper endoscopies at baseline and at one, three, and six months with the primary endpoint as the cumulative incidence of gastric ulcers. The FDA has recently informed POZEN that the appropriateness of this endpoint is the subject of an internal review and an FDA internal meeting is planned in Q1 2009 to discuss this matter.
POZEN and AstraZeneca entered into a co-development agreement for PN 400 in August 2006. PN 400 is an investigational product under clinical development in patients who require chronic non-steroidal anti-inflammation drug (NSAID) treatment for arthritis pain, such as osteoarthritis and who are at risk for developing NSAID-associated gastric ulcers. The NDA submission is planned for mid-2009. Full results of the PN 400 Phase 3 studies will be published in a timely manner.
Osteoarthritis is one of the most frequent causes of physical disability among adults. An estimated 46 million adults in the U.S. have physician diagnosed arthritis, accounting for 21 percent of the U.S. adult population, and two thirds of the people that have doctor-diagnosed arthritis are under the age of 65. Fifty percent of people on chronic NSAID's are at risk for developing NSAID-associated gastric ulcers.
About POZEN
POZEN is a pharmaceutical company committed to developing therapeutic advancements for diseases with unmet medical needs where it can improve efficacy, safety, and/or patient convenience. POZEN's efforts are focused primarily on the development of pharmaceutical products for the treatment of acute and chronic pain and other pain-related conditions. POZEN has development and commercialization alliances with GlaxoSmithKline for Treximet®, which was approved by the United States Food and Drug Administration for the acute treatment of migraine attacks; and with AstraZeneca for proprietary fixed dose combinations of naproxen with the proton pump inhibitor esomeprazole magnesium in a single tablet for conditions such as osteoarthritis and rheumatoid arthritis in patients who are at risk for developing NSAID-associated gastric ulcers. The company's common stock is traded on The Nasdaq Stock Market under the symbol "POZN". For detailed company information, including copies of this and other press releases, see POZEN's website: pozen.
Statements included in this press release that are not historical in nature are "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management's current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our failure to successfully commercialize our product candidates; costs and delays in the development and/or FDA approval of our product candidates, including as a result of the need to conduct additional studies, or the failure to obtain such approval of our product candidates, including as a result of changes in regulatory standards or the regulatory environment during the development period of any of our product candidates, such as the current uncertainty regarding primary clinical endpoints for our PN and PA programs; uncertainties in clinical trial results or the timing of such trials, resulting in, among other things, an extension in the period over which we recognize deferred revenue or our failure to achieve milestones that would have provided us with revenue; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products, including our dependence on GlaxoSmithKline for the sales and marketing of Treximet; competitive factors, including the potential introduction of competing generic products; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; our inability to obtain any additional required financing; technological changes; government regulation; changes in industry practice; and one-time events, including those discussed herein and in our Quarterly Report on Form 10-Q for the period ended September 30, 2008. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.
POZEN Inc.
Massive meta analysis clarifies cardiovascular safety of celecoxib (Celebrex)
The COX-2 specific inhibitor celecoxib (Celebrex) is not associated with an increased risk of serious cardiovascular thrombotic events compared to placebo or NSAIDs, according to a meta-analysis of 41 clinical studies in 44,308 patients, reported at the American College of Rheumatology (ACR) 2005 Annual Scientific Meeting, San Diego, California (November 12-17th).
The meta analysis, reported by Dr Lee Simon, Associate Clinical Professor of Medicine at Harvard Medical School, evaluated the cardiovascular safety of celecoxib versus both placebo and nonselective (ns) NSAIDs.
Clinical trials included in the analysis lasted at least two weeks and included end points evaluating the incidence of heart attack, stroke and death and a composite sum of these three end points, explained Dr Simon, a former Division Director of the Arthritis, Analgesic & Ophthalmologic Drug Product Division at the Center for Drug Evaluation and Research, United States Food and Drug Administration.
The meta-analysis showed that patients taking celecoxib had no more risk for heart attack, stroke, or CV death combined than those given placebo or ns-NSAIDs.
There were no significant differences in the number of strokes among patients given celecoxib or placebo. However, there were significantly more strokes among patients taking ns-NSAIDs than those treated with celecoxib.
The number of heart attacks was numerically higher with celecoxib than with ns-NSAIDs. However, the difference was not statistically significant. When evaluated against people taking placebo, people taking celecoxib had no significant difference in the number of heart attacks.
"There were no cardiovascular signals that were any different to the active comparators. Celecoxib was no different to non selective drugs in terms of cardiovascular risk," he said. Comparators included placebo, naproxen, diclofenac, ibuprofen, loxoprofen, acetaminophen and ketoprofen.
Significantly fewer patients receiving celecoxib experienced hypertension or oedema compared with those receiving nonselective NSAIDs. Furthermore, the incidence of cardiac failure was numerically lower in the celecoxib group than in the nonselective NSAID group, he explained.
"In this large meta-analysis comprising studies of two weeks to three years duration involving patients with chronic conditions, celecoxib at doses of 200mg or more total daily dose was not associated with an increased risk of serious CV thromboembolic events compared with placebo or nonselective NSAIDs," Dr Simon concluded.
Dr Gail Cawkwell, Senior Medical Director, Arthritis, Pain and Musculoskeletal at Pfizer (the company that funded the meta analysis) said that the study was being prepared for publication in a peer reviewed journal, and the data had been shared with US and EU regulatory authorities.
"This analysis confirms once again that medicines like naproxen, ibuprofen and diclofenac have very similar rates of cardiovascular endpoints (combination of heart attack, stroke and cardiovascular deaths) compared to Celebrex. It is unfortunate that European labelling separates Celebrex from those medications. The US labelling reflects what has been shown by this meta analysis: that all these drugs have a similar cardiovascular safety profile, they all carry similar risks."
"All NSAIDs, selective and nonselective, carry similar levels of risk. We certainly feel there is a level playing field. Whatever risks people have been facing for decades with medicines such as ibuprofen, albeit unknowingly, are now a bit clearer, and that those risks are similar for a medicine like Celebrex."
There was further heartening news for celecoxib from an unrelated study reported at the ACR. The GAIT study (Abstract 622) compared the dietary supplements glucosamine and chondroitin sulphate (alone and in combination) against celecoxib in 1583 patients. Lead author Dr Daniel Clegg, University of Utah, said that there was no difference between placebo and the dietary supplements: only celecoxib reached the primary efficacy endpoint. Given concern over the cardiovascular safety of coxibs, Dr Clegg said that the FDA had asked for an interim safety analysis to see if there was any signal of cardiac problems in celecoxib- versus dietary-supplement treated patients. "There was no such signal, the treatment arms of the study had indistinguishable safety profiles," he said.
Reference
Simon LS, White WB, MacDonald TM, Pan S, Rosenstein RB, Gaffney M. Cardiovascular safety of celecoxib: A meta-analysis of 41 clinical studies in 44,300 patients. Abstract 1049, American College of Rheumatology annual meeting November 2005. Published in Arthritis and Rheumatism, Volume 52, No 9, 2005 page S406.
Written by: Ian Mason
ianmasonntlworld
View drug information on Ketoprofen.
The meta analysis, reported by Dr Lee Simon, Associate Clinical Professor of Medicine at Harvard Medical School, evaluated the cardiovascular safety of celecoxib versus both placebo and nonselective (ns) NSAIDs.
Clinical trials included in the analysis lasted at least two weeks and included end points evaluating the incidence of heart attack, stroke and death and a composite sum of these three end points, explained Dr Simon, a former Division Director of the Arthritis, Analgesic & Ophthalmologic Drug Product Division at the Center for Drug Evaluation and Research, United States Food and Drug Administration.
The meta-analysis showed that patients taking celecoxib had no more risk for heart attack, stroke, or CV death combined than those given placebo or ns-NSAIDs.
There were no significant differences in the number of strokes among patients given celecoxib or placebo. However, there were significantly more strokes among patients taking ns-NSAIDs than those treated with celecoxib.
The number of heart attacks was numerically higher with celecoxib than with ns-NSAIDs. However, the difference was not statistically significant. When evaluated against people taking placebo, people taking celecoxib had no significant difference in the number of heart attacks.
"There were no cardiovascular signals that were any different to the active comparators. Celecoxib was no different to non selective drugs in terms of cardiovascular risk," he said. Comparators included placebo, naproxen, diclofenac, ibuprofen, loxoprofen, acetaminophen and ketoprofen.
Significantly fewer patients receiving celecoxib experienced hypertension or oedema compared with those receiving nonselective NSAIDs. Furthermore, the incidence of cardiac failure was numerically lower in the celecoxib group than in the nonselective NSAID group, he explained.
"In this large meta-analysis comprising studies of two weeks to three years duration involving patients with chronic conditions, celecoxib at doses of 200mg or more total daily dose was not associated with an increased risk of serious CV thromboembolic events compared with placebo or nonselective NSAIDs," Dr Simon concluded.
Dr Gail Cawkwell, Senior Medical Director, Arthritis, Pain and Musculoskeletal at Pfizer (the company that funded the meta analysis) said that the study was being prepared for publication in a peer reviewed journal, and the data had been shared with US and EU regulatory authorities.
"This analysis confirms once again that medicines like naproxen, ibuprofen and diclofenac have very similar rates of cardiovascular endpoints (combination of heart attack, stroke and cardiovascular deaths) compared to Celebrex. It is unfortunate that European labelling separates Celebrex from those medications. The US labelling reflects what has been shown by this meta analysis: that all these drugs have a similar cardiovascular safety profile, they all carry similar risks."
"All NSAIDs, selective and nonselective, carry similar levels of risk. We certainly feel there is a level playing field. Whatever risks people have been facing for decades with medicines such as ibuprofen, albeit unknowingly, are now a bit clearer, and that those risks are similar for a medicine like Celebrex."
There was further heartening news for celecoxib from an unrelated study reported at the ACR. The GAIT study (Abstract 622) compared the dietary supplements glucosamine and chondroitin sulphate (alone and in combination) against celecoxib in 1583 patients. Lead author Dr Daniel Clegg, University of Utah, said that there was no difference between placebo and the dietary supplements: only celecoxib reached the primary efficacy endpoint. Given concern over the cardiovascular safety of coxibs, Dr Clegg said that the FDA had asked for an interim safety analysis to see if there was any signal of cardiac problems in celecoxib- versus dietary-supplement treated patients. "There was no such signal, the treatment arms of the study had indistinguishable safety profiles," he said.
Reference
Simon LS, White WB, MacDonald TM, Pan S, Rosenstein RB, Gaffney M. Cardiovascular safety of celecoxib: A meta-analysis of 41 clinical studies in 44,300 patients. Abstract 1049, American College of Rheumatology annual meeting November 2005. Published in Arthritis and Rheumatism, Volume 52, No 9, 2005 page S406.
Written by: Ian Mason
ianmasonntlworld
View drug information on Ketoprofen.
Meniscus Transplant Can Ease Suffering Of Painful Knee
A meniscus transplant, a rarely performed arthroscopic procedure, might help delay the onset of arthritis and relieve knee pain for young, active people.
"This can be a great procedure for someone under the age of 50 who has pain after a significant meniscal injury or multiple previous meniscus surgeries and is too young and active for a knee replacement," said Dr. Patrick McCulloch, an orthopedic surgeon with the Methodist Center for Sports Medicine in Houston.
"In some cases, the meniscus has been damaged so severely that it has to be removed. This surgery works for people who have no functioning meniscus and have limited damage to the cartilage surfaces of the joint."
The meniscus is a piece of rubbery cartilage that sits between the bones in the knee and acts as a shock absorber and helps to stabilize the knee. People who have had the meniscus removed are more likely to see degenerative changes in the knee joint. This can cause the remaining cartilage that covers the bone to wear away, exposing the bone, which is extremely painful.
"When someone is left with little or no meniscus, we find an organ donor with the same size knee," McCulloch said. "We transplant the meniscus into the patient's knee and once it heals, the hope is that it will act like a normal meniscus and relieve pain."
This technique is used to slow down the progression of arthritis in the knee. While some patients will eventually need a knee replacement, this procedure can give them a number of years of pain-free activity before this has to be considered.
"A meniscus transplant is an arthroscopic procedure, but patients can expect to be on crutches for four to six weeks and spend a few months in rehabilitation," McCulloch said. "My focus is on joint restoration and procedures that regenerate cartilage in the knee. The meniscus transplant is another positive procedure that can relieve pain and keep people active."
Source: Methodist Hospital, Houston
"This can be a great procedure for someone under the age of 50 who has pain after a significant meniscal injury or multiple previous meniscus surgeries and is too young and active for a knee replacement," said Dr. Patrick McCulloch, an orthopedic surgeon with the Methodist Center for Sports Medicine in Houston.
"In some cases, the meniscus has been damaged so severely that it has to be removed. This surgery works for people who have no functioning meniscus and have limited damage to the cartilage surfaces of the joint."
The meniscus is a piece of rubbery cartilage that sits between the bones in the knee and acts as a shock absorber and helps to stabilize the knee. People who have had the meniscus removed are more likely to see degenerative changes in the knee joint. This can cause the remaining cartilage that covers the bone to wear away, exposing the bone, which is extremely painful.
"When someone is left with little or no meniscus, we find an organ donor with the same size knee," McCulloch said. "We transplant the meniscus into the patient's knee and once it heals, the hope is that it will act like a normal meniscus and relieve pain."
This technique is used to slow down the progression of arthritis in the knee. While some patients will eventually need a knee replacement, this procedure can give them a number of years of pain-free activity before this has to be considered.
"A meniscus transplant is an arthroscopic procedure, but patients can expect to be on crutches for four to six weeks and spend a few months in rehabilitation," McCulloch said. "My focus is on joint restoration and procedures that regenerate cartilage in the knee. The meniscus transplant is another positive procedure that can relieve pain and keep people active."
Source: Methodist Hospital, Houston
New 'Biofactories' Produce Rare Healing Substances In The Endangered Devil's Claw Plant
Deep in Africa's Kalahari Desert lies the "Devil's claw," a plant that may hold the key to effective treatments for arthritis, tendonitis and other illnesses that affect millions each year. Unfortunately, years of drought have pushed the Devil's claw toward extinction, so scientists are scrambling to devise new ways to produce the valuable medicinal chemicals of the Devil's claw and other rare plants.
One group of scientists reported a major advance toward that goal here today at the 238th National Meeting of the American Chemical Society (ACS). They described the first successful method of producing the active ingredients in Devil's claw - ingredients that have made the Devil's claw a sensation in alternative medicine in Europe. Their technique may eventually lead to the development of "biofactories" that could produce huge quantities of rare plant extracts quickly and at little cost.
Milen I. Georgiev, Ph.D., who delivered the report, pointed out that for thousands of years, native populations in Southern Africa have used the Devil's claw as a remedy for a huge number of ailments, including fever, diarrhea and blood diseases. Today, there are dozens of medicinal and herbal products around the world that are based on chemicals derived from the Devil's claw.
In particular, studies suggest that two chemicals - the so-called iridoid glycosides harpagoside and harpagide - may have beneficial effects in the treatment of degenerative rheumatoid arthritis, osteoarthritis, tendonitis, and other conditions, Georgiev said.
"In Germany, 57 pharmaceutical products based on Devil's claw, marketed by 46 different companies, have cumulative sales volumes alone worth more than $40 million." Georgiev noted. In the United States, Devil's claw extracts are in phase II clinical trials for the treatment of hip and knee arthritis. Other promising uses are not far behind. But while the demand for these beneficial compounds is increasing, the supply of natural Devil's claw is dwindling.
"The Devil's Claw faces significant problems with its natural renewal, especially low rainfall," Georgiev notes. "These problems are driving efforts to find alternative ways to produce high value compounds from the plant, independent of geographical and climatic factors," he says.
Currently, more than 25 percent of all prescribed medicines used in industrialized countries are derived either directly or indirectly from plants, many of which are rare and sometimes endangered. "Hairy root," an infectious plant disease caused by the soil bacteria Agrobacterium rhizogenes, is at the core of a promising new technique that could one day lead to "biofactories" that produce medicines derived from rare plants in huge quantities at a low cost. Georgiev notes that hairy roots are a big improvement over traditional, greenhouse-based plant culturing.
"The transformed root cultures possess fast growth rates, genetic and biochemical stability and the capacity for synthesis of plant metabolites. It should be also mentioned that the amount of active metabolites in naturally grown plants in greenhouses significantly vary seasonally," notes Georgiev. Hairy root biofactories, on the other hand, could produce consistently high levels of plant metabolites year round.
Georgiev and his team are the first to induce hairy root cultures of Devil's claw. They took the roots of the Devil's claw and infected them with the A. rhizogenes soil bacteria - a natural genetic engineer - to create a system of hairy roots to produce the plant's key medicinal chemicals. Their studies demonstrated stable growth and high production of both iridoid glycosides harpagoside and harpagide. Previous studies were only capable of producing one of these two compounds.
Georgiev notes that there is a long way to go before hairy root biofactories become commercialized, but he hopes to make the technology ready for use within a few years.
"Our target aim is to develop such technology, so we are paying attention not only to fundamental scientific tasks, but also to those related to some of the technological problems associated with hairy root biofactories," Georgiev said. "It is the desire of each scientist is to see the fruits of his work. In the current case, we hope to be able to develop cost-effective laboratory technology for production of these pharmaceutically-important metabolites within the next five years."
Source:
Michael Bernstein
American Chemical Society
One group of scientists reported a major advance toward that goal here today at the 238th National Meeting of the American Chemical Society (ACS). They described the first successful method of producing the active ingredients in Devil's claw - ingredients that have made the Devil's claw a sensation in alternative medicine in Europe. Their technique may eventually lead to the development of "biofactories" that could produce huge quantities of rare plant extracts quickly and at little cost.
Milen I. Georgiev, Ph.D., who delivered the report, pointed out that for thousands of years, native populations in Southern Africa have used the Devil's claw as a remedy for a huge number of ailments, including fever, diarrhea and blood diseases. Today, there are dozens of medicinal and herbal products around the world that are based on chemicals derived from the Devil's claw.
In particular, studies suggest that two chemicals - the so-called iridoid glycosides harpagoside and harpagide - may have beneficial effects in the treatment of degenerative rheumatoid arthritis, osteoarthritis, tendonitis, and other conditions, Georgiev said.
"In Germany, 57 pharmaceutical products based on Devil's claw, marketed by 46 different companies, have cumulative sales volumes alone worth more than $40 million." Georgiev noted. In the United States, Devil's claw extracts are in phase II clinical trials for the treatment of hip and knee arthritis. Other promising uses are not far behind. But while the demand for these beneficial compounds is increasing, the supply of natural Devil's claw is dwindling.
"The Devil's Claw faces significant problems with its natural renewal, especially low rainfall," Georgiev notes. "These problems are driving efforts to find alternative ways to produce high value compounds from the plant, independent of geographical and climatic factors," he says.
Currently, more than 25 percent of all prescribed medicines used in industrialized countries are derived either directly or indirectly from plants, many of which are rare and sometimes endangered. "Hairy root," an infectious plant disease caused by the soil bacteria Agrobacterium rhizogenes, is at the core of a promising new technique that could one day lead to "biofactories" that produce medicines derived from rare plants in huge quantities at a low cost. Georgiev notes that hairy roots are a big improvement over traditional, greenhouse-based plant culturing.
"The transformed root cultures possess fast growth rates, genetic and biochemical stability and the capacity for synthesis of plant metabolites. It should be also mentioned that the amount of active metabolites in naturally grown plants in greenhouses significantly vary seasonally," notes Georgiev. Hairy root biofactories, on the other hand, could produce consistently high levels of plant metabolites year round.
Georgiev and his team are the first to induce hairy root cultures of Devil's claw. They took the roots of the Devil's claw and infected them with the A. rhizogenes soil bacteria - a natural genetic engineer - to create a system of hairy roots to produce the plant's key medicinal chemicals. Their studies demonstrated stable growth and high production of both iridoid glycosides harpagoside and harpagide. Previous studies were only capable of producing one of these two compounds.
Georgiev notes that there is a long way to go before hairy root biofactories become commercialized, but he hopes to make the technology ready for use within a few years.
"Our target aim is to develop such technology, so we are paying attention not only to fundamental scientific tasks, but also to those related to some of the technological problems associated with hairy root biofactories," Georgiev said. "It is the desire of each scientist is to see the fruits of his work. In the current case, we hope to be able to develop cost-effective laboratory technology for production of these pharmaceutically-important metabolites within the next five years."
Source:
Michael Bernstein
American Chemical Society
Ten Elsevier Books Win First Prize At BMA Medical Book Competition
Elsevier is pleased to announce that ten of its professional and scholarly books were honored at the annual BMA Medical Book Competition ceremony in London on September 8th 2009. An additional 19 Elsevier books were highly commended. In total, 684 books were entered to the BMA's competition with 126 prizes awarded with 26 first prizes, 91 highly commended prizes and 9 commended prizes.
Gray's Anatomy for Students by Richard Drake, Wayne Vogl, and Adam Mitchell won first prize in the BMA Basic and Clinical Science category. This is the second edition of an anatomy textbook for medical students that has quickly become a favorite textbook around the world, translated into a dozen languages. It has captured a strong following because it explains complex anatomy with clear, understandable language, strong clinical correlations, and a stunning full-color artwork program. It is now part of an extensive family of Gray's products including Gray's Atlas of Anatomy, Gray's Anatomy for Students Flashcards, Gray's Anatomy Review, Dorland/Gray's Pocket Atlas of Anatomy and, of course, Gray's Anatomy, 40th Edition.
Elsevier's Rheumatoid Arthritis by Marc C. Hochberg, Alan J. Silman, Josef S. Smolen, Michael E. Weinblatt, and Michael H. Weisman was awarded first prize in the BMA Orthopaedics and Rheumatology category. A first edition in brilliant color, it provides the most current insights into the pathogenesis of rheumatoid arthritis, while also including comprehensive coverage of clinical features of the disease, as well as evidence-based options for treatment.
"We congratulate all of the winners and especially thank all of the authors, editors and Elsevier publishing staff who have worked on these prize-winning titles," said Randy Charles, Managing Director Global Clinical Reference Group at Elsevier. "This is an amazing achievement and reflects our dedication to developing and delivering quality content."
First prizes were awarded to Elsevier books in the following categories:
Anesthesia: Andrew Bersten and Neil Soni - Oh's Intensive Care Manual, 6th edition
Basic and Clinical Science: Richard Drake, A. Wayne Vogl, and Adam WM Mitchell - Gray's Anatomy for Students, 2nd edition
Cardiology: John Hampton - The ECG in Practice, 5th edition
Haematology: Stuart H. Orkin and others - Nathan and Oski's Hematology of Infancy and Childhood, 7th edition
Health Care for the Elderly: Hylton B. Menz - Foot Problems in Older People
Medicine: Mark Strachan, Surendra Sharma and John Hunter - Davidson's Clinical Cases
Orthopaedics and Rheumatology: Marc C. Hochberg and others - Rheumatoid Arthritis
Primary Health Care: Andrew Polmear - Evidence-Based Diagnosis in Primary Care
Radiology: Gerald de Lacey, Simon Morley and Laurence Berman - The Chest X-Ray: A Survival Guide
BMA Student Textbook Award: Elspeth Brown and others - Heart Sounds Made Easy with CD-ROM, 2nd edition
Source:
Anna Hogrebe
Elsevier
Gray's Anatomy for Students by Richard Drake, Wayne Vogl, and Adam Mitchell won first prize in the BMA Basic and Clinical Science category. This is the second edition of an anatomy textbook for medical students that has quickly become a favorite textbook around the world, translated into a dozen languages. It has captured a strong following because it explains complex anatomy with clear, understandable language, strong clinical correlations, and a stunning full-color artwork program. It is now part of an extensive family of Gray's products including Gray's Atlas of Anatomy, Gray's Anatomy for Students Flashcards, Gray's Anatomy Review, Dorland/Gray's Pocket Atlas of Anatomy and, of course, Gray's Anatomy, 40th Edition.
Elsevier's Rheumatoid Arthritis by Marc C. Hochberg, Alan J. Silman, Josef S. Smolen, Michael E. Weinblatt, and Michael H. Weisman was awarded first prize in the BMA Orthopaedics and Rheumatology category. A first edition in brilliant color, it provides the most current insights into the pathogenesis of rheumatoid arthritis, while also including comprehensive coverage of clinical features of the disease, as well as evidence-based options for treatment.
"We congratulate all of the winners and especially thank all of the authors, editors and Elsevier publishing staff who have worked on these prize-winning titles," said Randy Charles, Managing Director Global Clinical Reference Group at Elsevier. "This is an amazing achievement and reflects our dedication to developing and delivering quality content."
First prizes were awarded to Elsevier books in the following categories:
Anesthesia: Andrew Bersten and Neil Soni - Oh's Intensive Care Manual, 6th edition
Basic and Clinical Science: Richard Drake, A. Wayne Vogl, and Adam WM Mitchell - Gray's Anatomy for Students, 2nd edition
Cardiology: John Hampton - The ECG in Practice, 5th edition
Haematology: Stuart H. Orkin and others - Nathan and Oski's Hematology of Infancy and Childhood, 7th edition
Health Care for the Elderly: Hylton B. Menz - Foot Problems in Older People
Medicine: Mark Strachan, Surendra Sharma and John Hunter - Davidson's Clinical Cases
Orthopaedics and Rheumatology: Marc C. Hochberg and others - Rheumatoid Arthritis
Primary Health Care: Andrew Polmear - Evidence-Based Diagnosis in Primary Care
Radiology: Gerald de Lacey, Simon Morley and Laurence Berman - The Chest X-Ray: A Survival Guide
BMA Student Textbook Award: Elspeth Brown and others - Heart Sounds Made Easy with CD-ROM, 2nd edition
Source:
Anna Hogrebe
Elsevier
New Lupus Drug Showed Positive Results In Trial Said Manufacturer
A phase 2 trial of the drug belimumab in patients with active systemic lupus erythematosus (SLE) showed positive results, according to the drug
company.
Human Genome Sciences (HGS) of Rockville, Maryland, USA, told delegates attending the 2009 Congress of the European League Against
Rheumatism (EULAR) in Copenhagen on 11 June that the four-year trial results showed "sustained improvement in disease activity and patient
response rate", frequency of disease flares went down, and there was no overall increase in adverse events, serious or otherwise.
HGS and GlaxoSmithKline (GSK) have agreed terms to develop and sell belimumab, formerly LymphoStat-B and now known under the brand name
Benlysta. Under the agreement HGS will conduct the phase 3 trial, with help from GSK.
Lupus is an autoimmune disease that affects mainly women in their childbearing years. The immune system attacks the patient's own body and tissue,
causing inflammation at the site of the attack, which varies from person to person.
Estimates suggest there are 5 million people worldwide living with various forms of lupus, including SLE, 1.5 million of them in the US. For many
people with lupus it is little more than a nuisance, but for some it is life-threatening.
Symptoms of lupus vary, depending on which part of the body is affected, for instance it could be a rash if the skin is attacked, or joint pain if the joints are
attacked. For this reason lupus often mimics other diseases such as multiple sclerosis and rheumatoid arthritis and can be very difficult to diagnose.
There is no single definitive test of the disease and accurate diagnosis relies on a number of factors, including symptoms and history.
There are two types of lupus: discoid, which affects only the skin, and the other is systemic (full name systemic lupus erythematosus, SLE), which
affects the skin, joints and often internal organs such as the heart and/or kidneys. Belimumab, the drug tested in this trial, is designed to treat the second type, SLE.
Dr Joan T Merrill, a study investigator, Program Chair, Clinical Pharmacology Research Program, Oklahoma Medical Research Foundation,
Oklahoma City, and Professor, Department of Medicine, University of Oklahoma Health Sciences Center, said that the results presented at EULAR
2009 suggest:
"The apparent durability of clinical effect and the favorable safety profile observed for belimumab suggest that belimumab has the potential to become
an important new treatment for patients with SLE."
HGS Vice President, Clinical Research - Immunology, Rheumatology and Infectious Diseases, Dr William W Freimuth, said they were encouraged by
the results and the safety data presented at the meeting.
"The incidence rates per 100 patient years of all adverse event categories, including serious adverse events, overall adverse events, and serious
infections were similar for belimumab and placebo during the 52-week double-blind period, and remained the same or decreased over four years of
continuous treatment," said Freimuth.
Depending on how well Benlysta (belimumab) performs in the phase 3 trial, the drug could "represent a significant advance in the treatment of SLE",
he added.
The phase 3 data for Benlysta will appear in July 2009 from the BLISS-52 trial, and in November 2009 from the BLISS-76 trial. Both these trials are
the largest clinical trials ever conducted in lupus patients, said HGS in a press statement.
Benlysta (belimumab) is a human monoclonal antibody that selectively targets and inhibits the B-lymphocyte stimulator (BLyS), a naturally occurring protein
discovered by HGS. The protein plays an important role in turning B-lymphocyte cells into mature plasma B cells, which produce antibodies, the
immune system's first line of defence against infection (the "foot soldiers" of the immune system).
Higher than normal levels of BLyS produce too many antibodies, which appears to correlate with the severity of disease in lupus and other
autoimmune illnesses.
"Preclinical and clinical studies demonstrate that BLyS antagonists can reduce autoantibody levels and help control autoimmune disease activity," said
the HGS statement, which stated that the trial data presented at the EULAR 2009 meeting showed:
Continued treatment with Benlysta (belimumab) was associated with "sustained improvement or stabilization of SLE disease activity and with
decreased frequency of SLE disease flares in serologically active patients through four years of treatment".
The overall incidence of adverse events, serious or otherwise, infections and malignancies, including lab abnormalities either decreased or
stabilized from week 52 to week 208 of the trial.
Increase from 46 to 57 per cent in the response rate that was chosen as the primary endpoint of the phase 3 trial. This was a cluster of measures,
including:" improvement in SELENA SLEDAI score of 4 points or more, no BILAG worsening, and no worsening in Physician's Global Assessment;
post hoc; intention-to-treat analysis".
Decrease from 62 to 16 per cent in the overall frequency of SLE flares, as measured by the SELENA SLEDAI Flare Index.
Plus a decrease from 8 to 1 per cent in frequency of severe flares.
Decrease from 23 to 5 per cent in frequency of patients having one new BILAG A organ domain score, or more than one new BILAG B organ
domain score (BILAG A indicates a severe flare, while B indicates a moderate flare due to lupus disease).
For the trial, which evaluated the effectiveness and safety of Benlysta (belimumab) plus standard care against placebo plus standard care, a total of 449
SLE patients were randomly assigned to have either one of three different doses of the active drug or placebo over 52 weeks.
At the end of 52 weeks, 345 of the patients chose to continue in an optional 24 week extension, during which all patients received the active drug. At
the end of 76 weeks, 296 patients chose to continue with belimumab in an "open-label long-term continuation phase" where all patients were given the
same dose. The current situation, as of 1 June 2009, is that 213 patients are still receiving treatment in the continuation study, said HGS.
Source: Human Genome Sciences, Arthritis Research Campaign.
Written by: , PhD
company.
Human Genome Sciences (HGS) of Rockville, Maryland, USA, told delegates attending the 2009 Congress of the European League Against
Rheumatism (EULAR) in Copenhagen on 11 June that the four-year trial results showed "sustained improvement in disease activity and patient
response rate", frequency of disease flares went down, and there was no overall increase in adverse events, serious or otherwise.
HGS and GlaxoSmithKline (GSK) have agreed terms to develop and sell belimumab, formerly LymphoStat-B and now known under the brand name
Benlysta. Under the agreement HGS will conduct the phase 3 trial, with help from GSK.
Lupus is an autoimmune disease that affects mainly women in their childbearing years. The immune system attacks the patient's own body and tissue,
causing inflammation at the site of the attack, which varies from person to person.
Estimates suggest there are 5 million people worldwide living with various forms of lupus, including SLE, 1.5 million of them in the US. For many
people with lupus it is little more than a nuisance, but for some it is life-threatening.
Symptoms of lupus vary, depending on which part of the body is affected, for instance it could be a rash if the skin is attacked, or joint pain if the joints are
attacked. For this reason lupus often mimics other diseases such as multiple sclerosis and rheumatoid arthritis and can be very difficult to diagnose.
There is no single definitive test of the disease and accurate diagnosis relies on a number of factors, including symptoms and history.
There are two types of lupus: discoid, which affects only the skin, and the other is systemic (full name systemic lupus erythematosus, SLE), which
affects the skin, joints and often internal organs such as the heart and/or kidneys. Belimumab, the drug tested in this trial, is designed to treat the second type, SLE.
Dr Joan T Merrill, a study investigator, Program Chair, Clinical Pharmacology Research Program, Oklahoma Medical Research Foundation,
Oklahoma City, and Professor, Department of Medicine, University of Oklahoma Health Sciences Center, said that the results presented at EULAR
2009 suggest:
"The apparent durability of clinical effect and the favorable safety profile observed for belimumab suggest that belimumab has the potential to become
an important new treatment for patients with SLE."
HGS Vice President, Clinical Research - Immunology, Rheumatology and Infectious Diseases, Dr William W Freimuth, said they were encouraged by
the results and the safety data presented at the meeting.
"The incidence rates per 100 patient years of all adverse event categories, including serious adverse events, overall adverse events, and serious
infections were similar for belimumab and placebo during the 52-week double-blind period, and remained the same or decreased over four years of
continuous treatment," said Freimuth.
Depending on how well Benlysta (belimumab) performs in the phase 3 trial, the drug could "represent a significant advance in the treatment of SLE",
he added.
The phase 3 data for Benlysta will appear in July 2009 from the BLISS-52 trial, and in November 2009 from the BLISS-76 trial. Both these trials are
the largest clinical trials ever conducted in lupus patients, said HGS in a press statement.
Benlysta (belimumab) is a human monoclonal antibody that selectively targets and inhibits the B-lymphocyte stimulator (BLyS), a naturally occurring protein
discovered by HGS. The protein plays an important role in turning B-lymphocyte cells into mature plasma B cells, which produce antibodies, the
immune system's first line of defence against infection (the "foot soldiers" of the immune system).
Higher than normal levels of BLyS produce too many antibodies, which appears to correlate with the severity of disease in lupus and other
autoimmune illnesses.
"Preclinical and clinical studies demonstrate that BLyS antagonists can reduce autoantibody levels and help control autoimmune disease activity," said
the HGS statement, which stated that the trial data presented at the EULAR 2009 meeting showed:
Continued treatment with Benlysta (belimumab) was associated with "sustained improvement or stabilization of SLE disease activity and with
decreased frequency of SLE disease flares in serologically active patients through four years of treatment".
The overall incidence of adverse events, serious or otherwise, infections and malignancies, including lab abnormalities either decreased or
stabilized from week 52 to week 208 of the trial.
Increase from 46 to 57 per cent in the response rate that was chosen as the primary endpoint of the phase 3 trial. This was a cluster of measures,
including:" improvement in SELENA SLEDAI score of 4 points or more, no BILAG worsening, and no worsening in Physician's Global Assessment;
post hoc; intention-to-treat analysis".
Decrease from 62 to 16 per cent in the overall frequency of SLE flares, as measured by the SELENA SLEDAI Flare Index.
Plus a decrease from 8 to 1 per cent in frequency of severe flares.
Decrease from 23 to 5 per cent in frequency of patients having one new BILAG A organ domain score, or more than one new BILAG B organ
domain score (BILAG A indicates a severe flare, while B indicates a moderate flare due to lupus disease).
For the trial, which evaluated the effectiveness and safety of Benlysta (belimumab) plus standard care against placebo plus standard care, a total of 449
SLE patients were randomly assigned to have either one of three different doses of the active drug or placebo over 52 weeks.
At the end of 52 weeks, 345 of the patients chose to continue in an optional 24 week extension, during which all patients received the active drug. At
the end of 76 weeks, 296 patients chose to continue with belimumab in an "open-label long-term continuation phase" where all patients were given the
same dose. The current situation, as of 1 June 2009, is that 213 patients are still receiving treatment in the continuation study, said HGS.
Source: Human Genome Sciences, Arthritis Research Campaign.
Written by: , PhD
Prescription Acetaminophen Drugs To Have 325 Milligram Limit To Protect Liver
Manufacturers that produce prescription combination products containing acetaminophen are being asked by the FDA to limit the dosage to 325 mg per capsule or tablet to protect liver toxicity. Acetaminophen relives fever and pain and can be found in several OTC (over-the-counter) and prescription medications, such as codeine, Percocet (oxycodone), and Vicodin (hydrocodone).
The FDA (Food and Drug Administration) has informed manufacturers that all their prescription products containing an acetaminophen combination will need updated labels, warning about potential severe liver injury risk.
The FDA, in a communiqu?© today, added that OTC acetaminophen medications are not included in this action.
Sandra Kweder, M.D., deputy director of the Office of New Drugs in FDA's Center for Drug Evaluation and Research (CDER), said:
"FDA is taking this action to make prescription combination pain medications containing acetaminophen safer for patients to use. Overdose from prescription combination products containing acetaminophen account for nearly half of all cases of acetaminophen-related liver failure in the United States; many of which result in liver transplant or death."
There should not be any shortages of pain medication, the FDA informed, because this action will be phased-in over the 3-year period. The Agency added that combination drugs with a 325mg acetaminophen limit offer effective pain relief.
Kweder, said:
"There is no immediate danger to patients who take these combination pain medications and they should continue to take them as directed by their health care provider. The risk of liver injury primarily occurs when patients take multiple products containing acetaminophen at one time and exceed the current maximum dose of 4,000 milligrams within a 24-hour period."
According to the FDA, acetaminophen is commonly used as an OTC fever and pain drug, and is often combined with other OTC medications, such as those for coughs and colds. This FDA action does not affect these over-the-counter products.
Continued reports of liver injury prompted the FDA to take this measure. The FDA proposes that boxed warnings be added to all combo-prescription products containing acetaminophen.
In the vast majority of cases, severe liver injury reports have occurred in individuals who overdosed - took more than the prescribed acetaminophen-combo dose for a 24-hour period, took more than one acetaminophen-containing drug simultaneously, or consumed alcohol while on acetaminophen treatment.
A panel of experts (FDA advisory committee) concluded in June, 2009 that prescription medications containing acetaminophen should have a stronger warning about severe liver injury on their labels.
"FDA Panel Votes To Restrict Acetaminophen"
Acute overdoses of acetaminophen can cause potentially fatal liver damage. In rare cases, some people can experience damage with normal dosages. Risk of damage is heightened by alcohol consumption. Acetaminophen is the main cause of acute liver damage in North America and Europe, and accounts for the majority of drug overdose cases in the USA, UK, New Zealand and Australia.
Source: FDA
Written by
View drug information on Oxycodone and Aspirin.
The FDA (Food and Drug Administration) has informed manufacturers that all their prescription products containing an acetaminophen combination will need updated labels, warning about potential severe liver injury risk.
The FDA, in a communiqu?© today, added that OTC acetaminophen medications are not included in this action.
Sandra Kweder, M.D., deputy director of the Office of New Drugs in FDA's Center for Drug Evaluation and Research (CDER), said:
"FDA is taking this action to make prescription combination pain medications containing acetaminophen safer for patients to use. Overdose from prescription combination products containing acetaminophen account for nearly half of all cases of acetaminophen-related liver failure in the United States; many of which result in liver transplant or death."
There should not be any shortages of pain medication, the FDA informed, because this action will be phased-in over the 3-year period. The Agency added that combination drugs with a 325mg acetaminophen limit offer effective pain relief.
Kweder, said:
"There is no immediate danger to patients who take these combination pain medications and they should continue to take them as directed by their health care provider. The risk of liver injury primarily occurs when patients take multiple products containing acetaminophen at one time and exceed the current maximum dose of 4,000 milligrams within a 24-hour period."
According to the FDA, acetaminophen is commonly used as an OTC fever and pain drug, and is often combined with other OTC medications, such as those for coughs and colds. This FDA action does not affect these over-the-counter products.
Continued reports of liver injury prompted the FDA to take this measure. The FDA proposes that boxed warnings be added to all combo-prescription products containing acetaminophen.
In the vast majority of cases, severe liver injury reports have occurred in individuals who overdosed - took more than the prescribed acetaminophen-combo dose for a 24-hour period, took more than one acetaminophen-containing drug simultaneously, or consumed alcohol while on acetaminophen treatment.
A panel of experts (FDA advisory committee) concluded in June, 2009 that prescription medications containing acetaminophen should have a stronger warning about severe liver injury on their labels.
"FDA Panel Votes To Restrict Acetaminophen"
Acute overdoses of acetaminophen can cause potentially fatal liver damage. In rare cases, some people can experience damage with normal dosages. Risk of damage is heightened by alcohol consumption. Acetaminophen is the main cause of acute liver damage in North America and Europe, and accounts for the majority of drug overdose cases in the USA, UK, New Zealand and Australia.
Source: FDA
Written by
View drug information on Oxycodone and Aspirin.
The Beneficial Effects Of Pregnancy And Childbearing On Arthritic Conditions May Be More Long-Term Than Previously Understood
Nulliparous women (those who have not given birth to children) are diagnosed with chronic arthritides (including ankylosing spondylitis, psoriatic arthritis and rheumatoid arthritis (RA) an average of 5.2 years before parous women (those who have given birth to children), according to a new study presented at EULAR 2009, the Annual Congress of the European League Against Rheumatism in Copenhagen, Denmark.
Previous studies have highlighted that pregnancy may be a protective factor against the development of RA, whereas this is the first study to assess the effect of pregnancy and having children on the development of chronic arthritic conditions in premenopausal women. Within the study, the mean age at time of diagnosis for nulliparous women was 26 years, compared with 31.2 years for parous women (p< 0.001).
Rheumatoid factor (an autoantibody sometimes found in the immune systems of people with RA) was also present in 37.1% of the nulliparous women compared with 41.1% of the parous women (p=0.21), which, although not statistically significant, may indicate that the parous women studied may possess a higher disposition to developing arthritis than the nulliparous women.
Dr Marianne Wallenius, of the Norwegian University of Science and Technology, Norway, who led the study, said: "Arthritic conditions tend to occur more commonly in women, particularly those of childbearing age. Some symptoms of RA, for example, can improve during pregnancy, but our study indicates that the processes of pregnancy and childbearing could delay the onset of arthritic conditions. Continued examination of the complex interactions between the female reproductive processes and the epidemiology of RA could yield further interesting insights."
The retrospective study analysed 557 women aged 18-45 years from the Norwegian Disease Modifying Antirheumatic Drug (NOR-DMARD) study, who were all diagnosed with chronic arthritides before the age of 45 years. Information about parous status was confirmed through linking the NOR-DMARD patient cohort with the Medical Birth Registry of Norway (MBRN).
The time of diagnosis was recorded at the time of enrollment into the study and group comparisons were performed with Mann-Whitney U test for continuous variables and chi-square tests for categorical variables. Cox multiple regression analyses were used to compare the age at diagnosis for nulliparous and parous women. The analyses were adjusted for smoking, length of education and age at the time of the current analyses.
Of the 557 women identified, 163 were nulliparous and 394 were parous (with a minimum of one delivery). The mean age at the time of the current analyses was 36.2 years for the nulliparious women, and 41.1 years for the parous women (p< 0.001).
Nulliparous women were found to have a significantly higher educational level than parous women (p=0.02), although smoking habits were not found to be significantly different between the groups (p=0.11). Unadjusted in the Cox multiple regression analyses, the nulliparous women were diagnosed at a significantly earlier age than the parous women: RR (95% CI) 1.83 (p< 0.001). However, when adjusted for educational level, smoking and age at the current analyses, a significant difference was still observed: RR (95% CI) 1.23 (p=0.04).
Abstract number: FRI0532
Source:
Rory Berrie
European League Against Rheumatism
Previous studies have highlighted that pregnancy may be a protective factor against the development of RA, whereas this is the first study to assess the effect of pregnancy and having children on the development of chronic arthritic conditions in premenopausal women. Within the study, the mean age at time of diagnosis for nulliparous women was 26 years, compared with 31.2 years for parous women (p< 0.001).
Rheumatoid factor (an autoantibody sometimes found in the immune systems of people with RA) was also present in 37.1% of the nulliparous women compared with 41.1% of the parous women (p=0.21), which, although not statistically significant, may indicate that the parous women studied may possess a higher disposition to developing arthritis than the nulliparous women.
Dr Marianne Wallenius, of the Norwegian University of Science and Technology, Norway, who led the study, said: "Arthritic conditions tend to occur more commonly in women, particularly those of childbearing age. Some symptoms of RA, for example, can improve during pregnancy, but our study indicates that the processes of pregnancy and childbearing could delay the onset of arthritic conditions. Continued examination of the complex interactions between the female reproductive processes and the epidemiology of RA could yield further interesting insights."
The retrospective study analysed 557 women aged 18-45 years from the Norwegian Disease Modifying Antirheumatic Drug (NOR-DMARD) study, who were all diagnosed with chronic arthritides before the age of 45 years. Information about parous status was confirmed through linking the NOR-DMARD patient cohort with the Medical Birth Registry of Norway (MBRN).
The time of diagnosis was recorded at the time of enrollment into the study and group comparisons were performed with Mann-Whitney U test for continuous variables and chi-square tests for categorical variables. Cox multiple regression analyses were used to compare the age at diagnosis for nulliparous and parous women. The analyses were adjusted for smoking, length of education and age at the time of the current analyses.
Of the 557 women identified, 163 were nulliparous and 394 were parous (with a minimum of one delivery). The mean age at the time of the current analyses was 36.2 years for the nulliparious women, and 41.1 years for the parous women (p< 0.001).
Nulliparous women were found to have a significantly higher educational level than parous women (p=0.02), although smoking habits were not found to be significantly different between the groups (p=0.11). Unadjusted in the Cox multiple regression analyses, the nulliparous women were diagnosed at a significantly earlier age than the parous women: RR (95% CI) 1.83 (p< 0.001). However, when adjusted for educational level, smoking and age at the current analyses, a significant difference was still observed: RR (95% CI) 1.23 (p=0.04).
Abstract number: FRI0532
Source:
Rory Berrie
European League Against Rheumatism
Rheumatoid Arthritis - New Data Also Proves MabThera's Inhibition Of Joint Damage Is Maintained Over Two Years
A recent study [1] has called into question the practice of putting rheumatoid arthritis (RA) patients onto a second tumour necrosis factor (TNF) inhibitor therapy, a commonly used class of RA drugs, when they do not respond to the first TNF inhibitor.
The study, presented at the EULAR annual meeting (European League Against Rheumatism) in Paris, revealed that when RA patients do not respond to a TNF inhibitor, it is more effective to treat them with MabThera (rituximab), an RA drug with a different mode of action, than to use a second TNF inhibitor therapy.1
The study was conducted among 300 patients who had previously not responded to TNF inhibitor therapy. It analyzed the improvement in the disease activity score (DAS28)2 of patients receiving MabThera compared to patients receiving an alternative TNF inhibitor. Data at six months showed that MabThera achieved a significantly larger reduction in disease activity (DAS28) than a subsequent TNF inhibitor in patients who had interrupted TNF inhibitor therapy due to lack of efficacy (reduction in DAS28 by 1.55 versus 1.03)1.
"These findings are significant because they confirm the benefit of switching to an alternative biological agent, such as rituximab, in the subset of RA patients who don't respond to a first anti-TNF agent", said Dr Axel Finckh, Rheumatology Division, University of Geneva, Switzerland, presenting the results. "In patients with persistent active disease despite anti-TNF therapy, our data suggest that switching to rituximab is more effective than switching to an alternative anti-TNF agent."
Inhibition of joint damage
New data from another study, REFLEX3, also presented at EULAR, demonstrate that MabThera continues to significantly inhibit the progression of joint damage caused by RA over a period of two years in those patients who do not respond to TNF inhibitor therapy4. X-ray evidence at two years showed that the narrowing of joint spaces and appearance of new bone erosions were reduced by more than 50% in patients receiving MabThera and methotrexate (a commonly used RA drug) compared to patients receiving methotrexate alone (Genant-modified Sharp Score increase of 1.14 versus 2.81 respectively, p
Patient preference
Additional data presented at EULAR identified that RA patients prefer treatments with infrequent administration. Based on a range of treatment preferences and key drivers of choice, the study found that patients favour a treatment like MabThera which offers symptom control with extended interval time between treatment administrations, therefore providing minimum disruption to a patient's life6.
About rheumatoid arthritis and MabThera
Rheumatoid arthritis (RA) is an autoimmune disease characterized by inflammation that leads to stiff, swollen and painful joints. This ultimately results in irreversible joint damage and disability. MabThera selectively targets B cells and represents a new highly effective therapeutic approach for RA in addition to existing treatments such as disease-modifying anti-rheumatic drugs (DMARDs) and tumour necrosis factor (TNF) inhibitors.
B cells are known to play a key role in the inflammation associated with RA. As the first and only selective B cell therapy available for the treatment of RA, MabThera represents a proven and truly different alternative for patients who have inadequate response or are not able to tolerate TNF inhibitor therapy. MabThera is the only RA treatment that has demonstrated the ability to preserve joint structure in this patient group and offers an unprecedented duration of response of at least six months with each course. Each course of MabThera also provides the opportunity of sustained or improved relief for patients from the signs and symptoms of their disease.
MabThera is marketed in the US by Genentech and Biogen Idec under the brand name Rituxan®.
For a selection of broadcast footage clips relating to MabThera and rheumatoid arthritis please visit thenewsmarket/roche.
To view and download high resolution stills and media materials please visit the MabThera Virtual Press Office at mabthera-ra
About Roche in rheumatoid arthritis
One of the most important drivers for growth at Roche over the next few years is expected to be the company's emerging franchise in autoimmune diseases with rheumatoid arthritis as the first indication. Following the launch of MabThera (rituximab) there are a number of projects in development, potentially allowing Roche to build on further opportunities. MabThera is the first and only selective B-cell therapy for RA, providing a fundamentally different treatment approach by targeting B cells, one of the key players in the pathogenesis of RA. Actemra is Roche's second novel medicine and is a humanised monoclonal antibody to the interleukin-6 (IL-6) receptor, inhibiting the activity of IL-6, a protein that plays a major role in the RA inflammation process. Additional projects creating a rich pipeline include compounds in Phase I, II and III clinical trials. Notably, ocrelizumab, a humanised anti-CD20 antibody, has entered phase III development for RA.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world's biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. In 2007 sales by the Pharmaceuticals Division totalled 36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3 billion francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 79,000 people. Additional information is available on the Internet at roche.
All trademarks used or mentioned in this release are legally protected.
References
1. Finckh, A et al. Which subgroup of rheumatoid arthritis patients benefit most from switching to rituximab versus alternative anti-TNF agents after previous failure to anti-TNF agent? Abstract OP-0249, EULAR 2008
2. DAS28 is a measurement score used to assess whether a patient shows an improvement in disease activity. DAS28 provides a number on a scale from 0 to 10 which indicates the current activity of the disease.
3. A Randomised Evaluation oF Long-term Efficacy of rituXimab in RA
4. Cohen, S et al. Continued inhibition of structural damage in rheumatoid arthritis patients treated with rituximab at 2 tears: REFLEX study. Abstract THU0167, EULAR 2008
5. As measured by the mean increase from baseline in the total Genant-modified Sharp Score, an x-ray measurement of change in joint damage
6. Ostor, AJK et al. Patient preference for rituximab as a treatment for rheumatoid arthritis: a study using discrete choice analysis. Abstract AB0375, EULAR 2008
roche
View drug information on Actemra; Rituxan.
The study, presented at the EULAR annual meeting (European League Against Rheumatism) in Paris, revealed that when RA patients do not respond to a TNF inhibitor, it is more effective to treat them with MabThera (rituximab), an RA drug with a different mode of action, than to use a second TNF inhibitor therapy.1
The study was conducted among 300 patients who had previously not responded to TNF inhibitor therapy. It analyzed the improvement in the disease activity score (DAS28)2 of patients receiving MabThera compared to patients receiving an alternative TNF inhibitor. Data at six months showed that MabThera achieved a significantly larger reduction in disease activity (DAS28) than a subsequent TNF inhibitor in patients who had interrupted TNF inhibitor therapy due to lack of efficacy (reduction in DAS28 by 1.55 versus 1.03)1.
"These findings are significant because they confirm the benefit of switching to an alternative biological agent, such as rituximab, in the subset of RA patients who don't respond to a first anti-TNF agent", said Dr Axel Finckh, Rheumatology Division, University of Geneva, Switzerland, presenting the results. "In patients with persistent active disease despite anti-TNF therapy, our data suggest that switching to rituximab is more effective than switching to an alternative anti-TNF agent."
Inhibition of joint damage
New data from another study, REFLEX3, also presented at EULAR, demonstrate that MabThera continues to significantly inhibit the progression of joint damage caused by RA over a period of two years in those patients who do not respond to TNF inhibitor therapy4. X-ray evidence at two years showed that the narrowing of joint spaces and appearance of new bone erosions were reduced by more than 50% in patients receiving MabThera and methotrexate (a commonly used RA drug) compared to patients receiving methotrexate alone (Genant-modified Sharp Score increase of 1.14 versus 2.81 respectively, p
Patient preference
Additional data presented at EULAR identified that RA patients prefer treatments with infrequent administration. Based on a range of treatment preferences and key drivers of choice, the study found that patients favour a treatment like MabThera which offers symptom control with extended interval time between treatment administrations, therefore providing minimum disruption to a patient's life6.
About rheumatoid arthritis and MabThera
Rheumatoid arthritis (RA) is an autoimmune disease characterized by inflammation that leads to stiff, swollen and painful joints. This ultimately results in irreversible joint damage and disability. MabThera selectively targets B cells and represents a new highly effective therapeutic approach for RA in addition to existing treatments such as disease-modifying anti-rheumatic drugs (DMARDs) and tumour necrosis factor (TNF) inhibitors.
B cells are known to play a key role in the inflammation associated with RA. As the first and only selective B cell therapy available for the treatment of RA, MabThera represents a proven and truly different alternative for patients who have inadequate response or are not able to tolerate TNF inhibitor therapy. MabThera is the only RA treatment that has demonstrated the ability to preserve joint structure in this patient group and offers an unprecedented duration of response of at least six months with each course. Each course of MabThera also provides the opportunity of sustained or improved relief for patients from the signs and symptoms of their disease.
MabThera is marketed in the US by Genentech and Biogen Idec under the brand name Rituxan®.
For a selection of broadcast footage clips relating to MabThera and rheumatoid arthritis please visit thenewsmarket/roche.
To view and download high resolution stills and media materials please visit the MabThera Virtual Press Office at mabthera-ra
About Roche in rheumatoid arthritis
One of the most important drivers for growth at Roche over the next few years is expected to be the company's emerging franchise in autoimmune diseases with rheumatoid arthritis as the first indication. Following the launch of MabThera (rituximab) there are a number of projects in development, potentially allowing Roche to build on further opportunities. MabThera is the first and only selective B-cell therapy for RA, providing a fundamentally different treatment approach by targeting B cells, one of the key players in the pathogenesis of RA. Actemra is Roche's second novel medicine and is a humanised monoclonal antibody to the interleukin-6 (IL-6) receptor, inhibiting the activity of IL-6, a protein that plays a major role in the RA inflammation process. Additional projects creating a rich pipeline include compounds in Phase I, II and III clinical trials. Notably, ocrelizumab, a humanised anti-CD20 antibody, has entered phase III development for RA.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world's biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. In 2007 sales by the Pharmaceuticals Division totalled 36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3 billion francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 79,000 people. Additional information is available on the Internet at roche.
All trademarks used or mentioned in this release are legally protected.
References
1. Finckh, A et al. Which subgroup of rheumatoid arthritis patients benefit most from switching to rituximab versus alternative anti-TNF agents after previous failure to anti-TNF agent? Abstract OP-0249, EULAR 2008
2. DAS28 is a measurement score used to assess whether a patient shows an improvement in disease activity. DAS28 provides a number on a scale from 0 to 10 which indicates the current activity of the disease.
3. A Randomised Evaluation oF Long-term Efficacy of rituXimab in RA
4. Cohen, S et al. Continued inhibition of structural damage in rheumatoid arthritis patients treated with rituximab at 2 tears: REFLEX study. Abstract THU0167, EULAR 2008
5. As measured by the mean increase from baseline in the total Genant-modified Sharp Score, an x-ray measurement of change in joint damage
6. Ostor, AJK et al. Patient preference for rituximab as a treatment for rheumatoid arthritis: a study using discrete choice analysis. Abstract AB0375, EULAR 2008
roche
View drug information on Actemra; Rituxan.
New Platelet Rich Plasma Study Shows Promise For Knee Osteoarthritis
The first American study that positions Platelet Rich Plasma Therapy (PRP) as a viable means in managing knee osteoarthritis, appeared today in the December issue of the American Journal of Physical Medicine & Rehabilitation (AJPMR). The study, authored by Dr. Steven Sampson of the Orthohealing Center in Los Angeles, details the account of 14 patients with primary and secondary knee osteoarthritis receiving three platelet-rich plasma injections in the affected knee at 4-week intervals with one year follow up. The study demonstrated significant and almost linear improvements in pain and function with majority of the patients expressing favorable outcomes at 12-months after the PRP treatment. The American Journal of Physical Medicine & Rehabilitation is published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health, a leading provider of information and business intelligence for students, professionals, and institutions in medicine, nursing, allied health, and pharmacy.
"PRP is no longer a treatment that only benefits high-profile athletes," states Dr. Sampson, "The positive effects of this therapy are quickly spreading into many areas of mainstream medicine." Dr. Sampson further explains, "This pilot study sets the foundation for a large multi-center clinical trial to further demonstrate if PRP is safe and effective for the treatment of knee osteoarthritis." Dr. Sampson adds, "We are facing an epidemic with patients suffering from arthritis at earlier ages. Unfortunately most conservative options are limited and address the symptoms of inflammation, rather than address the biochemical process of the disease."
PRP is a non-surgical healing treatment used in many fields including plastic surgery, cardiothoracic surgery, and dentistry. Blood is made up of primarily red and white blood cells, plasma, and platelets. Each of these components has a specific role, for example white blood cells fight off infection. Platelets are known to release powerful healing proteins called "growth factors" that coordinate repair and regeneration of soft tissue. By spinning the blood in a machine called a centrifuge, doctors are able to isolate out the platelets, increasing their concentration up to 1000%. Then these growth factors are injected under ultrasound guidance directly into the injury to stimulate healing. Using cutting edge technology, doctors are able to guide the platelets within a millimeter of the target site for maximal benefit. Based on current research, soft tissue injuries are the most responsive to PRP. This includes tendon and ligament injuries, and muscle tears. Because of a growing need for non-surgical treatments for arthritis, PRP has been applied to osteoarthritis of joints throughout the body.
The implications from this study invite the need for a large-scale research effort to further position PRP as a strong candidate in managing osteoarthritis.
Source:
Wolters Kluwer Health: Lippincott Williams & Wilkins
Orthohealing Center
"PRP is no longer a treatment that only benefits high-profile athletes," states Dr. Sampson, "The positive effects of this therapy are quickly spreading into many areas of mainstream medicine." Dr. Sampson further explains, "This pilot study sets the foundation for a large multi-center clinical trial to further demonstrate if PRP is safe and effective for the treatment of knee osteoarthritis." Dr. Sampson adds, "We are facing an epidemic with patients suffering from arthritis at earlier ages. Unfortunately most conservative options are limited and address the symptoms of inflammation, rather than address the biochemical process of the disease."
PRP is a non-surgical healing treatment used in many fields including plastic surgery, cardiothoracic surgery, and dentistry. Blood is made up of primarily red and white blood cells, plasma, and platelets. Each of these components has a specific role, for example white blood cells fight off infection. Platelets are known to release powerful healing proteins called "growth factors" that coordinate repair and regeneration of soft tissue. By spinning the blood in a machine called a centrifuge, doctors are able to isolate out the platelets, increasing their concentration up to 1000%. Then these growth factors are injected under ultrasound guidance directly into the injury to stimulate healing. Using cutting edge technology, doctors are able to guide the platelets within a millimeter of the target site for maximal benefit. Based on current research, soft tissue injuries are the most responsive to PRP. This includes tendon and ligament injuries, and muscle tears. Because of a growing need for non-surgical treatments for arthritis, PRP has been applied to osteoarthritis of joints throughout the body.
The implications from this study invite the need for a large-scale research effort to further position PRP as a strong candidate in managing osteoarthritis.
Source:
Wolters Kluwer Health: Lippincott Williams & Wilkins
Orthohealing Center
Biogen Idec Researchers Identify Potential New Pathway In Rheumatoid Arthritis Disease Process
Researchers at Biogen Idec (NASDAQ: BIIB), a global biotechnology leader with products and capabilities in oncology, neurology and immunology, reported in the August 15, 2006 issue of the Journal of Immunology that activation of a recently discovered inflammation pathway may play an important role in the disease process that causes rheumatoid arthritis (RA). The studies advance the understanding of RA and demonstrate that inhibiting the TWEAK molecule may provide a new approach to developing RA treatments.
Discovered by Biogen Idec and University of Geneva scientists, TWEAK belongs to a family of molecules called tumor necrosis factor (TNF) that plays an important role in normal immune system and inflammatory responses. TNF-inhibiting therapies are currently used to treat a number of diseases including RA, a chronic, autoimmune disease that causes inflammation and swelling of the joints and the surrounding synovial tissue, resulting in progressive damage to the cartilage and bone.
TWEAK stimulates blood vessel growth (angiogenesis) and production of inflammatory proteins called cytokines and chemokines. The published studies found that TWEAK promotes a number of events that are hallmarks of rheumatoid arthritis, including joint inflammation and synovial angiogenesis (blood vessel growth in joints).
"Despite considerable progress, many rheumatoid arthritis patients do not adequately respond to current treatments, indicating that other pathways are involved in this complex disease," said Timothy Zheng, Ph.D., Senior Scientist, Molecular Discovery at Biogen Idec. "Our investigative research suggests that TWEAK contributes to the disease through multiple mechanisms, and inhibiting the TWEAK pathway may represent a new set of opportunities for treatment."
Specifically, the Biogen Idec researchers found that TWEAK promotes joint inflammation by stimulating the production of several types of inflammatory proteins, triggers joint damage by stimulating the production of damaging metalloprotease enzymes and promoting bone breakdown, and contributes to joint tissue disease by directly promoting angiogenesis in synovial tissue. The studies also suggest that TWEAK may impede normal bone repair mechanisms.
"Our research is part of a broader effort to identify the role of the TWEAK pathway in several autoimmune diseases," added Linda Burkly, Ph.D., the TWEAK program leader at Biogen Idec.
About Biogen Idec.
Biogen Idec creates new standards of care in oncology, neurology and immunology. As a global leader in the development, manufacturing, and commercialization of novel therapies, Biogen Idec transforms scientific discoveries into advances in human healthcare. For press releases and additional information about the company, please visit biogenidec.
Discovered by Biogen Idec and University of Geneva scientists, TWEAK belongs to a family of molecules called tumor necrosis factor (TNF) that plays an important role in normal immune system and inflammatory responses. TNF-inhibiting therapies are currently used to treat a number of diseases including RA, a chronic, autoimmune disease that causes inflammation and swelling of the joints and the surrounding synovial tissue, resulting in progressive damage to the cartilage and bone.
TWEAK stimulates blood vessel growth (angiogenesis) and production of inflammatory proteins called cytokines and chemokines. The published studies found that TWEAK promotes a number of events that are hallmarks of rheumatoid arthritis, including joint inflammation and synovial angiogenesis (blood vessel growth in joints).
"Despite considerable progress, many rheumatoid arthritis patients do not adequately respond to current treatments, indicating that other pathways are involved in this complex disease," said Timothy Zheng, Ph.D., Senior Scientist, Molecular Discovery at Biogen Idec. "Our investigative research suggests that TWEAK contributes to the disease through multiple mechanisms, and inhibiting the TWEAK pathway may represent a new set of opportunities for treatment."
Specifically, the Biogen Idec researchers found that TWEAK promotes joint inflammation by stimulating the production of several types of inflammatory proteins, triggers joint damage by stimulating the production of damaging metalloprotease enzymes and promoting bone breakdown, and contributes to joint tissue disease by directly promoting angiogenesis in synovial tissue. The studies also suggest that TWEAK may impede normal bone repair mechanisms.
"Our research is part of a broader effort to identify the role of the TWEAK pathway in several autoimmune diseases," added Linda Burkly, Ph.D., the TWEAK program leader at Biogen Idec.
About Biogen Idec.
Biogen Idec creates new standards of care in oncology, neurology and immunology. As a global leader in the development, manufacturing, and commercialization of novel therapies, Biogen Idec transforms scientific discoveries into advances in human healthcare. For press releases and additional information about the company, please visit biogenidec.
Lifestyle Coaching Program Helps People with Rheumatoid Arthritis Remain Active
The Arthritis Foundation, Amgen and Wyeth Pharmaceuticals (NYSE:WYE) today introduced "RheumMates"(TM), a lifestyle-coaching program for people with rheumatoid arthritis (RA) to help manage the physical and emotional impact of this disease. At the core of the program is RheumMates, a new online resource creating a virtual partnership between lifestyle experts and people with RA to help them understand treatment options and help them maintain an active life. The site offers content, tools and advice from experts in fields such as fitness, nutrition, relationships and careers.
Starting today, people can register on RheumMates for an interactive Web cast being held on August 6, 2004, featuring fitness expert Bob Greene. This will be the first in a series of Web casts on the site. Greene, who rose to fame as Oprah Winfrey's personal trainer and is the best selling author of "Get With the Program," will share his advice and encouragement for living a fit and active life. Joining Greene will be John H. Klippel, M.D., president and CEO of the Arthritis Foundation.
The two experts will share their strategies to help people with RA stay active to gain greater control of their disease. RheumMates is a Web site complementing the Arthritis Foundation's RA Connect community at arthritis.
"RA can be a devastating disease that can take a toll on every aspect of a person's life. It can affect anyone, but primarily targets women in their young- to mid-adult years," said Dr. Klippel. "The Internet is making it easier for people with RA and their families to get information about the condition and connect with others who have the disease. In addition to finding appropriate treatment with a rheumatologist, we encourage people with RA and their families to start utilizing RheumMates' and to take an active role in limiting the potential impact of RA."
"RA can pose serious challenges to physical activity and flexibility, but it does not have to mean the end of an active and healthy life," said Bob Greene. "We believe that my approach to fitness, involving mind, body and spirit, will help empower and motivate people with RA to start or restart an appropriate fitness program."
Affecting more than 2 million Americans, RA is a chronic and potentially disabling autoimmune disease that can cause painful swelling and stiffness in the joints of the hands, feet and wrists. Left untreated or improperly diagnosed, joint damage can limit a person's ability to function. The symptoms of RA can make any task difficult, from simple acts such as getting dressed or holding a cup of coffee, to more complex activities such as cooking, playing golf or gardening.
It is critical for people with RA to work closely with a rheumatologist to obtain appropriate treatment that can help manage often painful and devastating symptoms.
A wide range of treatment options is available to help manage the symptoms of RA, from exercise and joint protection, to medication such as non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, disease-modifying anti-rheumatic drugs and biologic agents.
Biologic agents are a new class of medications that can specifically target parts of the immune system that are affected by RA and can lead to joint and tissue damage. These treatments not only relieve pain and reduce inflammation, but are the only treatments indicated to inhibit the progression of joint damage, which may lead to improved patient mobility and vitality.
"An important goal, both physically and mentally for many people with RA, is to resume their normal daily activities following their diagnosis," said Dr. Klippel. "People with RA need support for the whole person. In addition to staying active, it is essential that people with RA seek out a comprehensive treatment plan that can help them improve their mobility and limit the affects of joint damage."
"RheumMates": Lifestyle Coaching for Active Living
"RheumMates" is a lifestyle coaching program for people with RA to learn about the real-life impact of their diagnosis, provide tools for understanding treatment options, and get expert advice to help meet the challenges of daily living. Offering content, tools and advice from experts in fields such as fitness, nutrition, relationships and careers, RheumMates is an online resource creating a virtual partnership between lifestyle experts and people with RA to help them maintain an active lifestyle. "RheumMates" was created by the Arthritis Foundation, along with Amgen and Wyeth Pharmaceuticals, as a new resource for the millions of Americans with RA.
About the Arthritis Foundation
The Arthritis Foundation is the only nationwide, non-profit health organization helping people take greater control of arthritis by leading efforts to prevent, control and cure arthritis and related diseases -- the nation's number one cause of disability. For free information about arthritis, contact the Arthritis Foundation at 1-800-283-7800 or on the Web at arthritis.
About Amgen and Wyeth Pharmaceuticals
Amgen is a global biotechnology company that discovers, develops, manufactures and markets important human therapeutics based on advances in cellular and molecular biology. Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, cardiovascular disease, central nervous system, inflammation, hemophilia, oncology and vaccines. Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
CONTACT: Amgen
Andrea Rothschild, 805-447-4587
or
Wyeth Pharmaceuticals
Jenifer Antonacci, 484-865-5220
or
Arthritis Foundation
Kerry Spivey, 404-965-7635
SOURCE: Amgen
Starting today, people can register on RheumMates for an interactive Web cast being held on August 6, 2004, featuring fitness expert Bob Greene. This will be the first in a series of Web casts on the site. Greene, who rose to fame as Oprah Winfrey's personal trainer and is the best selling author of "Get With the Program," will share his advice and encouragement for living a fit and active life. Joining Greene will be John H. Klippel, M.D., president and CEO of the Arthritis Foundation.
The two experts will share their strategies to help people with RA stay active to gain greater control of their disease. RheumMates is a Web site complementing the Arthritis Foundation's RA Connect community at arthritis.
"RA can be a devastating disease that can take a toll on every aspect of a person's life. It can affect anyone, but primarily targets women in their young- to mid-adult years," said Dr. Klippel. "The Internet is making it easier for people with RA and their families to get information about the condition and connect with others who have the disease. In addition to finding appropriate treatment with a rheumatologist, we encourage people with RA and their families to start utilizing RheumMates' and to take an active role in limiting the potential impact of RA."
"RA can pose serious challenges to physical activity and flexibility, but it does not have to mean the end of an active and healthy life," said Bob Greene. "We believe that my approach to fitness, involving mind, body and spirit, will help empower and motivate people with RA to start or restart an appropriate fitness program."
Affecting more than 2 million Americans, RA is a chronic and potentially disabling autoimmune disease that can cause painful swelling and stiffness in the joints of the hands, feet and wrists. Left untreated or improperly diagnosed, joint damage can limit a person's ability to function. The symptoms of RA can make any task difficult, from simple acts such as getting dressed or holding a cup of coffee, to more complex activities such as cooking, playing golf or gardening.
It is critical for people with RA to work closely with a rheumatologist to obtain appropriate treatment that can help manage often painful and devastating symptoms.
A wide range of treatment options is available to help manage the symptoms of RA, from exercise and joint protection, to medication such as non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, disease-modifying anti-rheumatic drugs and biologic agents.
Biologic agents are a new class of medications that can specifically target parts of the immune system that are affected by RA and can lead to joint and tissue damage. These treatments not only relieve pain and reduce inflammation, but are the only treatments indicated to inhibit the progression of joint damage, which may lead to improved patient mobility and vitality.
"An important goal, both physically and mentally for many people with RA, is to resume their normal daily activities following their diagnosis," said Dr. Klippel. "People with RA need support for the whole person. In addition to staying active, it is essential that people with RA seek out a comprehensive treatment plan that can help them improve their mobility and limit the affects of joint damage."
"RheumMates": Lifestyle Coaching for Active Living
"RheumMates" is a lifestyle coaching program for people with RA to learn about the real-life impact of their diagnosis, provide tools for understanding treatment options, and get expert advice to help meet the challenges of daily living. Offering content, tools and advice from experts in fields such as fitness, nutrition, relationships and careers, RheumMates is an online resource creating a virtual partnership between lifestyle experts and people with RA to help them maintain an active lifestyle. "RheumMates" was created by the Arthritis Foundation, along with Amgen and Wyeth Pharmaceuticals, as a new resource for the millions of Americans with RA.
About the Arthritis Foundation
The Arthritis Foundation is the only nationwide, non-profit health organization helping people take greater control of arthritis by leading efforts to prevent, control and cure arthritis and related diseases -- the nation's number one cause of disability. For free information about arthritis, contact the Arthritis Foundation at 1-800-283-7800 or on the Web at arthritis.
About Amgen and Wyeth Pharmaceuticals
Amgen is a global biotechnology company that discovers, develops, manufactures and markets important human therapeutics based on advances in cellular and molecular biology. Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, cardiovascular disease, central nervous system, inflammation, hemophilia, oncology and vaccines. Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
CONTACT: Amgen
Andrea Rothschild, 805-447-4587
or
Wyeth Pharmaceuticals
Jenifer Antonacci, 484-865-5220
or
Arthritis Foundation
Kerry Spivey, 404-965-7635
SOURCE: Amgen
Brightly-coloured fruit and veg may protect against arthritis
Rheumatoid arthritis currently affects around 1% adults in the UK. Previous studies have suggested that vitamin C and the pigment beta-cryptoxanthin, both of which are found in brightly-coloured fruit and veg, may act as antioxidants, and protect the body against the oxidative damage which can cause inflammation.
The Manchester team, based in the Arthritis Research Campaign's Epidemiology Unit, worked with researchers from the Institute of Public Health at the University of Cambridge to analyse health questionnaires and diet diaries by over 25000 45-74 year-olds; completed as part of the EPIC (European Prospective Investigation of Cancer) Norfolk study of diet and chronic disease in the 1990s. They then followed-up the participants over a nine year period to identify new cases of inflammatory polyarthritis (IP), including rheumatoid arthritis.
Dr Dorothy Pattison, who led the research, said: "We found that the average daily beta-cryptoxanthin intake of the 88 patients who had developed inflammatory polyarthritis was 40% lower than those who hadn't, and their intake of another carotenoid, zeaxanthin, was 20% lower.
"Those in the top third for beta-cryptoxanthin intake were only half as likely to develop IP as those in the lowest third, and vitamin C was also found to be an important factor."
The findings appear to confirm previous evidence that a modest increase in fruit and vegetables containing beta-cryptoxanthin and vitamin C, equivalent to one glass of freshly-squeezed orange juice each day, might help to protect against developing inflammatory joint diseases.
Dr Pattison has previously published research which found that both low intakes of fruit and vegetables (in particular those high in vitamin C), and high levels of red meat consumption were associated with an increased risk of developing IP.
A full paper on the findings of the research appears in the August issue of The American Journal of Clinical Nutrition (ajcn/current.shtml).
The EPIC Norfolk study is funded by the Medical Research Council, Cancer Research UK and the British Heart Foundation.
The University of Manchester (manchester.ac.uk) was formed by the merger of The Victoria University of Manchester and UMIST in October 2004, and with 36 000 students expected in the coming academic year is the largest higher education institution in the country. Its Faculty of Medical & Human Sciences (mhs.manchester.ac.uk) is one of the largest faculties of clinical and health sciences in Europe, with a research income of over ?37 million.
The School of Medicine (medicine.manchester.ac.uk) is the largest of the Faculty's five Schools, with 1300 staff, almost 2000 undergraduates and a ?32M research income. The School encompasses five teaching hospitals, and is closely linked to a range of general hospitals and community practices across the North West of England.
The Arthritis Research Campaign (arc) is the fourth largest medical research charity in the UK, funding research totalling ?20 million annually. For more information please contact arc press officer Jane Tadman on 01246 541107 or visit arc.uk.
The University of Cambridge's (cam.ac.uk) reputation for outstanding academic achievement is known worldwide and reflects the intellectual achievement of its students as well as the world-class original research carried out by the staff of the University and the Colleges.
As Cambridge approaches its 800th anniversary in 2009, it continues to change in response to the challenges it faces. The modern University is an international centre of teaching and research in a vast range of subjects: about half of the students study science or technology. Members of the University have won over 80 Nobel Prizes.
Jo NIghtingale
joanne.nightingalemanchester.ac.uk
44-161-275-8156
University of Manchester
manchester.ac.uk
The Manchester team, based in the Arthritis Research Campaign's Epidemiology Unit, worked with researchers from the Institute of Public Health at the University of Cambridge to analyse health questionnaires and diet diaries by over 25000 45-74 year-olds; completed as part of the EPIC (European Prospective Investigation of Cancer) Norfolk study of diet and chronic disease in the 1990s. They then followed-up the participants over a nine year period to identify new cases of inflammatory polyarthritis (IP), including rheumatoid arthritis.
Dr Dorothy Pattison, who led the research, said: "We found that the average daily beta-cryptoxanthin intake of the 88 patients who had developed inflammatory polyarthritis was 40% lower than those who hadn't, and their intake of another carotenoid, zeaxanthin, was 20% lower.
"Those in the top third for beta-cryptoxanthin intake were only half as likely to develop IP as those in the lowest third, and vitamin C was also found to be an important factor."
The findings appear to confirm previous evidence that a modest increase in fruit and vegetables containing beta-cryptoxanthin and vitamin C, equivalent to one glass of freshly-squeezed orange juice each day, might help to protect against developing inflammatory joint diseases.
Dr Pattison has previously published research which found that both low intakes of fruit and vegetables (in particular those high in vitamin C), and high levels of red meat consumption were associated with an increased risk of developing IP.
A full paper on the findings of the research appears in the August issue of The American Journal of Clinical Nutrition (ajcn/current.shtml).
The EPIC Norfolk study is funded by the Medical Research Council, Cancer Research UK and the British Heart Foundation.
The University of Manchester (manchester.ac.uk) was formed by the merger of The Victoria University of Manchester and UMIST in October 2004, and with 36 000 students expected in the coming academic year is the largest higher education institution in the country. Its Faculty of Medical & Human Sciences (mhs.manchester.ac.uk) is one of the largest faculties of clinical and health sciences in Europe, with a research income of over ?37 million.
The School of Medicine (medicine.manchester.ac.uk) is the largest of the Faculty's five Schools, with 1300 staff, almost 2000 undergraduates and a ?32M research income. The School encompasses five teaching hospitals, and is closely linked to a range of general hospitals and community practices across the North West of England.
The Arthritis Research Campaign (arc) is the fourth largest medical research charity in the UK, funding research totalling ?20 million annually. For more information please contact arc press officer Jane Tadman on 01246 541107 or visit arc.uk.
The University of Cambridge's (cam.ac.uk) reputation for outstanding academic achievement is known worldwide and reflects the intellectual achievement of its students as well as the world-class original research carried out by the staff of the University and the Colleges.
As Cambridge approaches its 800th anniversary in 2009, it continues to change in response to the challenges it faces. The modern University is an international centre of teaching and research in a vast range of subjects: about half of the students study science or technology. Members of the University have won over 80 Nobel Prizes.
Jo NIghtingale
joanne.nightingalemanchester.ac.uk
44-161-275-8156
University of Manchester
manchester.ac.uk
Increased Incidence Of Melanoma Found In Rheumatoid Arthritis Patients Treated With Methotrexate
A chronic, inflammatory disease of unknown origin, rheumatoid arthritis (RA) affects about 1 percent of adults worldwide. Marked by joint destruction, RA often leads to disability and diminished quality of life. It can also lead to an early death from cancer. Various studies have linked RA to an increased risk of Hodgkin's and non-Hodgkin's lymphoma, leukemia, myeloma, and lung cancer. A link between methotrexate (MTX), a disease-modifying antirheumatic drug (DMARD) commonly prescribed to RA patients, and cancer has also been suggested. Numerous case reports of RA patients treated with MTX developing lymphoma and, even more strikingly, tumors disappearing when the drug was discontinued, have prompted concern that MTX itself may be carcinogenic. So far, however, studies addressing this concern have been inconclusive.
To shed further light on the cancer risk for RA patients treated with MTX, researchers in Australia, where RA affects over 2 percent of adults, studied the cancer incidence in RA patients treated with MTX by local doctors. Their findings, featured in the June 2008 issue of Arthritis Care & Research, suggest an increased risk of melanoma, as well as other malignancies, for RA patients receiving MTX.
The study focused on 459 RA patients, 309 women and 150 men, regularly seen by 1 of 6 rheumatologists based in Melbourne. All had started treatment with MTX prior to June 1986. The majority had no previous history of immunosuppressant therapy. 61 percent were rheumatoid factor positive. Researchers set out to determine the cancer incidence in these patients compared with the general population and compared with the results of published studies on the incidence of malignancy in MTX-treated RA populations in other countries. For all patients, followup started on the date they first started MTX therapy and ended on the date of their last confirmed doctor visit or death. Over the total of 4,273 person-years of followup, an average of 9.3 years per patient, 87 malignancies were identified.
Researchers then compared the cancer incidence observed among these RA patients with that of their healthy peers in Victoria, Australia. Standard incidence ratios (SRIs) for all malignancies and for selected cancers were calculated using state population cancer rates, stratified by sex, age (in 5 age groups: under 40, 40-49, 50-59, 60-69, and 70 and over), and calendars years, from 1983-1999. Cox regression analysis was also performed, including positive rheumatoid factor and ever use of two immunosuppressive agents, azathioprine and cyclophosphamide.
RA patients exposed to MTX were found to have an estimated 50 percent excess risk of developing cancer in any form. The risk of non-Hodgkin's lymphoma was more than 5 times higher in RA patients than in the general population. RA patients also had a 3-fold increased risk of melanoma and almost a 3-fold increased risk of lung cancer.
While the increased risk levels for non-Hodgkin's lymphoma and lung cancer were in line with the findings of related studies in Europe and the United States, the high risk for melanoma stood out as novel. "This study is, to our knowledge, the first to report an increased risk of melanoma in patients with RA treated with MTX compared with the general population," notes its lead author, Dr. Rachelle Buchbinder.
Interestingly, the researchers observed a 2.5-fold increased cancer risk for MTX-treated RA patients exposed to cyclophosphamide, but contrary to expectation, no increased risk with exposure to azathioprine.
Despite its limitations - lack of a RA control group who was not exposed to MTX, for one - this study has important implications, particularly in regard to the risk of melanoma for RA patients. "Further investigation is needed to determine whether this risk is unique to Australia and what role MTX, immunosuppression per se, and/or environmental factors such as exposure to UV radiation play in its development," Dr. Buchbinder stresses. "Our findings, taken together with other studies investigating the risk of skin cancer in patients with RA, may support a role for regular skin cancer screening for all patients with RA, particularly those receiving immunosuppressive therapy."
Article: "Incidence of Melanoma and Other Malignancies Among Rheumatoid Arthritis Patients Treated With Methotrexate," Rachelle Buchbinder, Melissa Barber, Louise Heuzenroeder, Anita E. Wluka, Graham Giles, Stephen Hall, Andrew Harkness, Daniel Lewis, Geoff Littlejohn, Marian H. Miller, Peter F.J. Ryan, and Damien Jolley, Arthritis & Rheumatism (Arthritis Care & Research), June 15, 2008; 59:6, pp. 794-799.
Source: Sean Wagner
Wiley-Blackwell
To shed further light on the cancer risk for RA patients treated with MTX, researchers in Australia, where RA affects over 2 percent of adults, studied the cancer incidence in RA patients treated with MTX by local doctors. Their findings, featured in the June 2008 issue of Arthritis Care & Research, suggest an increased risk of melanoma, as well as other malignancies, for RA patients receiving MTX.
The study focused on 459 RA patients, 309 women and 150 men, regularly seen by 1 of 6 rheumatologists based in Melbourne. All had started treatment with MTX prior to June 1986. The majority had no previous history of immunosuppressant therapy. 61 percent were rheumatoid factor positive. Researchers set out to determine the cancer incidence in these patients compared with the general population and compared with the results of published studies on the incidence of malignancy in MTX-treated RA populations in other countries. For all patients, followup started on the date they first started MTX therapy and ended on the date of their last confirmed doctor visit or death. Over the total of 4,273 person-years of followup, an average of 9.3 years per patient, 87 malignancies were identified.
Researchers then compared the cancer incidence observed among these RA patients with that of their healthy peers in Victoria, Australia. Standard incidence ratios (SRIs) for all malignancies and for selected cancers were calculated using state population cancer rates, stratified by sex, age (in 5 age groups: under 40, 40-49, 50-59, 60-69, and 70 and over), and calendars years, from 1983-1999. Cox regression analysis was also performed, including positive rheumatoid factor and ever use of two immunosuppressive agents, azathioprine and cyclophosphamide.
RA patients exposed to MTX were found to have an estimated 50 percent excess risk of developing cancer in any form. The risk of non-Hodgkin's lymphoma was more than 5 times higher in RA patients than in the general population. RA patients also had a 3-fold increased risk of melanoma and almost a 3-fold increased risk of lung cancer.
While the increased risk levels for non-Hodgkin's lymphoma and lung cancer were in line with the findings of related studies in Europe and the United States, the high risk for melanoma stood out as novel. "This study is, to our knowledge, the first to report an increased risk of melanoma in patients with RA treated with MTX compared with the general population," notes its lead author, Dr. Rachelle Buchbinder.
Interestingly, the researchers observed a 2.5-fold increased cancer risk for MTX-treated RA patients exposed to cyclophosphamide, but contrary to expectation, no increased risk with exposure to azathioprine.
Despite its limitations - lack of a RA control group who was not exposed to MTX, for one - this study has important implications, particularly in regard to the risk of melanoma for RA patients. "Further investigation is needed to determine whether this risk is unique to Australia and what role MTX, immunosuppression per se, and/or environmental factors such as exposure to UV radiation play in its development," Dr. Buchbinder stresses. "Our findings, taken together with other studies investigating the risk of skin cancer in patients with RA, may support a role for regular skin cancer screening for all patients with RA, particularly those receiving immunosuppressive therapy."
Article: "Incidence of Melanoma and Other Malignancies Among Rheumatoid Arthritis Patients Treated With Methotrexate," Rachelle Buchbinder, Melissa Barber, Louise Heuzenroeder, Anita E. Wluka, Graham Giles, Stephen Hall, Andrew Harkness, Daniel Lewis, Geoff Littlejohn, Marian H. Miller, Peter F.J. Ryan, and Damien Jolley, Arthritis & Rheumatism (Arthritis Care & Research), June 15, 2008; 59:6, pp. 794-799.
Source: Sean Wagner
Wiley-Blackwell
FDA Approves New Test To Aid In The Diagnosis Of Rheumatoid Arthritis
An important assay used to aid in the diagnosis of rheumatoid arthritis (RA) will soon be available on Abbott's ARCHITECT immunoassay analyzers. The FDA has granted 510(k) clearance for an antibody cyclic-citrulinated peptide, or anti-CCP assay, to run on the world class systems.
Many patients with RA develop an immune response against proteins containing citrulline long before they present symptoms of the disease. Studies show detecting the level of these antibodies earlier in the disease continuum, in conjunction with other clinical information, is critical to the early diagnosis of the disease. The American College of Rheumatology treatment guidelines for RA recommends early diagnosis of the disease and timely introduction of therapies to prevent potentially irreversible joint damage.
The assay was developed by Axis-Shield to run on Abbott's ARCHITECT i1000SR and i2000SR systems. The anti-CCP assay is already approved and available on the Abbott ARCHITECT outside the United States.
"The approval of the anti-CCP assay for use on the ARCHITECT provides an important tool for physicians to aid in the early diagnosis of RA. We are pleased to add this assay to the existing panel of autoimmune disease biomarker assays currently available on the ARCHITECT and clinical chemistry platforms as we underscore Abbott's continued commitment to the area of immunology," said Michael Warmuth, senior vice president, diagnostics, Abbott.
Important Product Usage and Safety Information
The ARCHITECT Anti-CCP assay is a chemiluminescent microparticle immunoassay (CMIA) for the semi-quantitative determination of the lgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum or plasma on the ARCHITECT i System. Detection of anti-CCP antibodies is used as an aid in the diagnosis of Rheumatoid Arthritis (RA) and should be used in conjunction with other clinical information. This product is for in vitro diagnostic use only. Use of this product requires the handling of human specimens, and it is recommended that all human-sourced materials be considered potentially infectious. This product contains sodium azide, and both the material and its container should be disposed of safely. Assay specific information is presented in the assay package insert which can be accessed at abbottdiagnostics once the product is available.
About the ARCHITECT Instrument Family
The ARCHITECT family of analyzers includes the i1000SR and i2000SR for immunoassay testing, the c4000, c8000, and c16000 for clinical chemistry testing, and the ci4100, ci8200, and ci16200 integrated immunoassay/chemistry systems. Abbott's unique technologies include the Robotic Sample Handler to prioritize emergency tests; sample clot and bubble detection to verify sampling integrity; and FlexRate and CHEMIFLEX assay technologies. ARCHITECT systems use identical easy-to-use software and common reagents across all members of the family.
About Abbott Diagnostics
Abbott Diagnostics is a global leader in in vitro diagnostics and offers a broad range of innovative instrument systems and tests for hospitals, reference labs, blood banks, physician offices and clinics. With more than 69,000 institutional customers in more than 100 countries, Abbott's diagnostic products offer customers automation, convenience, cost effectiveness and flexibility. Abbott has helped transform the practice of medical diagnostics from an art to a science through the company's commitment to improving patient care and lowering overall costs. The history of Abbott Diagnostics is filled with examples of first-of-a-kind products and significant technological advancements, including the development of the very first diagnostic test to detect HIV.
About Abbott Immunology
Abbott is a leader in the discovery and development of innovative treatments and diagnostics for immunologic diseases, including rheumatoid arthritis. The ARCHITECT integrated platform provides RA testing including anti-CCP, Rheumatoid Factor, and C-reactive protein (CRP). The Abbott Bioresearch Center in Worcester, Massachusetts is the center of the company's efforts to discover and develop new medicines for autoimmune diseases.
Source
Abbott Laboratories
Many patients with RA develop an immune response against proteins containing citrulline long before they present symptoms of the disease. Studies show detecting the level of these antibodies earlier in the disease continuum, in conjunction with other clinical information, is critical to the early diagnosis of the disease. The American College of Rheumatology treatment guidelines for RA recommends early diagnosis of the disease and timely introduction of therapies to prevent potentially irreversible joint damage.
The assay was developed by Axis-Shield to run on Abbott's ARCHITECT i1000SR and i2000SR systems. The anti-CCP assay is already approved and available on the Abbott ARCHITECT outside the United States.
"The approval of the anti-CCP assay for use on the ARCHITECT provides an important tool for physicians to aid in the early diagnosis of RA. We are pleased to add this assay to the existing panel of autoimmune disease biomarker assays currently available on the ARCHITECT and clinical chemistry platforms as we underscore Abbott's continued commitment to the area of immunology," said Michael Warmuth, senior vice president, diagnostics, Abbott.
Important Product Usage and Safety Information
The ARCHITECT Anti-CCP assay is a chemiluminescent microparticle immunoassay (CMIA) for the semi-quantitative determination of the lgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum or plasma on the ARCHITECT i System. Detection of anti-CCP antibodies is used as an aid in the diagnosis of Rheumatoid Arthritis (RA) and should be used in conjunction with other clinical information. This product is for in vitro diagnostic use only. Use of this product requires the handling of human specimens, and it is recommended that all human-sourced materials be considered potentially infectious. This product contains sodium azide, and both the material and its container should be disposed of safely. Assay specific information is presented in the assay package insert which can be accessed at abbottdiagnostics once the product is available.
About the ARCHITECT Instrument Family
The ARCHITECT family of analyzers includes the i1000SR and i2000SR for immunoassay testing, the c4000, c8000, and c16000 for clinical chemistry testing, and the ci4100, ci8200, and ci16200 integrated immunoassay/chemistry systems. Abbott's unique technologies include the Robotic Sample Handler to prioritize emergency tests; sample clot and bubble detection to verify sampling integrity; and FlexRate and CHEMIFLEX assay technologies. ARCHITECT systems use identical easy-to-use software and common reagents across all members of the family.
About Abbott Diagnostics
Abbott Diagnostics is a global leader in in vitro diagnostics and offers a broad range of innovative instrument systems and tests for hospitals, reference labs, blood banks, physician offices and clinics. With more than 69,000 institutional customers in more than 100 countries, Abbott's diagnostic products offer customers automation, convenience, cost effectiveness and flexibility. Abbott has helped transform the practice of medical diagnostics from an art to a science through the company's commitment to improving patient care and lowering overall costs. The history of Abbott Diagnostics is filled with examples of first-of-a-kind products and significant technological advancements, including the development of the very first diagnostic test to detect HIV.
About Abbott Immunology
Abbott is a leader in the discovery and development of innovative treatments and diagnostics for immunologic diseases, including rheumatoid arthritis. The ARCHITECT integrated platform provides RA testing including anti-CCP, Rheumatoid Factor, and C-reactive protein (CRP). The Abbott Bioresearch Center in Worcester, Massachusetts is the center of the company's efforts to discover and develop new medicines for autoimmune diseases.
Source
Abbott Laboratories
Less Painful, More Effective Joint Injections Using Ultrasound
The use of ultrasound needle guidance improves the performance, outcomes and the cost-effectiveness of knee injections in people with osteoarthritis, according to research presented this week at the American College of Rheumatology Annual Scientific Meeting in Atlanta.
Osteoarthritis, or OA as it is commonly called, is the most common joint disease affecting middle-age and older people. It is characterized by progressive damage to the joint cartilage the cushioning material at the end of long bones and causes changes in the structures around the joint. These changes can include fluid accumulation, bony overgrowth, and loosening and weakness of muscles and tendons, all of which may limit movement and cause pain and swelling.
Researchers recently set out to determine if the use of ultrasound guidance would affect the outcomes of intraarticular injections injections of medicine into, or removal of fluid from, arthritic joints in people with knee OA. "Ultrasound, the use of sound waves to visualize the human body, is useful to physicians to guide the needle into the joint to inject medications to treat arthritis," explains Wilmer Sibbitt, Jr., MD; professor of rheumatology and neurology, University of New Mexico Health Sciences Center, Albuquerque, N.M. and an investigator in the study.
Dr. Sibbitt's research team studied 94 knees, which were randomly selected for injection administered either by the conventional palpation-guided method or by the newer ultrasound-guided method (which allowed researchers to watch, in real time, the needle entering and exiting the joint).
Both the palpation and ultrasound-guided methods involved one needle, with a syringe attached, entering the joint to remove fluid from it. After that was accomplished, the first syringe was removed (with the needle remaining inserted) and a second syringe was used to inject 80mg of a corticosteroid through the same needle. This technique ensured the medication was injected into the correct place. When using the ultrasound-guided method, researchers were able to perform the procedure while confirming needle placement as well as administration of the lidocaine and the corticosteroid by viewing the procedure as it occurred.
Each participant's initial pain, pain during the procedure, and knee pain at the end of two weeks and six months were studied. Researchers looked at who responded to the treatment, the length of time the participants experienced pain relief after the injection, how often participants needed to be reinjected, the total cost of the procedure, and the cost per participant who responded to the treatment.
When compared to the palpation-guided method, researchers found the use of the ultrasound-guided method to provide improved results including a 107 percent increase in the number of people who responded to the treatment and a 51.6 percent reduction in the number of people who did not.
Additionally, researchers noted a 47 percent reduction in pain during the procedure, a 41.7 percent reduction in pain two weeks after the injection, and a 35.5 percent increase in the length of time the participants experienced pain relief after the injection.
Finally, researchers compared the cost effectiveness of the ultrasound-guided method to the traditional palpation method. They found that the ultrasound method led to a 14.6 percent ($48) reduction in cost per participant per year and a 58.8 percent ($593) reduction in the cost per hospital-outpatient participant who responded to the treatment.
These results have led researchers to believe that the use of ultrasound-guidance in intraarticular injections is an approach that can improve the overall treatment of knee OA, which will improve treatment costs as a patient's need for additional expensive treatments can be reduced.
"The study demonstrates that when physicians use ultrasound and a technique called hydrodissection performed with precise new mechanical syringes to inject the joint, the patient experiences less pain, improved safety, a better response to medications, and less need for other medical therapy," says Dr. Sibbitt. "Rheumatologists are increasingly using ultrasound, and patients should be aware that joint injections may be more effective and less painful if their physician offers this option to them."
Patients should talk to their rheumatologists to determine their best course of treatment.
Source: American College of Rheumatology (ACR)
Osteoarthritis, or OA as it is commonly called, is the most common joint disease affecting middle-age and older people. It is characterized by progressive damage to the joint cartilage the cushioning material at the end of long bones and causes changes in the structures around the joint. These changes can include fluid accumulation, bony overgrowth, and loosening and weakness of muscles and tendons, all of which may limit movement and cause pain and swelling.
Researchers recently set out to determine if the use of ultrasound guidance would affect the outcomes of intraarticular injections injections of medicine into, or removal of fluid from, arthritic joints in people with knee OA. "Ultrasound, the use of sound waves to visualize the human body, is useful to physicians to guide the needle into the joint to inject medications to treat arthritis," explains Wilmer Sibbitt, Jr., MD; professor of rheumatology and neurology, University of New Mexico Health Sciences Center, Albuquerque, N.M. and an investigator in the study.
Dr. Sibbitt's research team studied 94 knees, which were randomly selected for injection administered either by the conventional palpation-guided method or by the newer ultrasound-guided method (which allowed researchers to watch, in real time, the needle entering and exiting the joint).
Both the palpation and ultrasound-guided methods involved one needle, with a syringe attached, entering the joint to remove fluid from it. After that was accomplished, the first syringe was removed (with the needle remaining inserted) and a second syringe was used to inject 80mg of a corticosteroid through the same needle. This technique ensured the medication was injected into the correct place. When using the ultrasound-guided method, researchers were able to perform the procedure while confirming needle placement as well as administration of the lidocaine and the corticosteroid by viewing the procedure as it occurred.
Each participant's initial pain, pain during the procedure, and knee pain at the end of two weeks and six months were studied. Researchers looked at who responded to the treatment, the length of time the participants experienced pain relief after the injection, how often participants needed to be reinjected, the total cost of the procedure, and the cost per participant who responded to the treatment.
When compared to the palpation-guided method, researchers found the use of the ultrasound-guided method to provide improved results including a 107 percent increase in the number of people who responded to the treatment and a 51.6 percent reduction in the number of people who did not.
Additionally, researchers noted a 47 percent reduction in pain during the procedure, a 41.7 percent reduction in pain two weeks after the injection, and a 35.5 percent increase in the length of time the participants experienced pain relief after the injection.
Finally, researchers compared the cost effectiveness of the ultrasound-guided method to the traditional palpation method. They found that the ultrasound method led to a 14.6 percent ($48) reduction in cost per participant per year and a 58.8 percent ($593) reduction in the cost per hospital-outpatient participant who responded to the treatment.
These results have led researchers to believe that the use of ultrasound-guidance in intraarticular injections is an approach that can improve the overall treatment of knee OA, which will improve treatment costs as a patient's need for additional expensive treatments can be reduced.
"The study demonstrates that when physicians use ultrasound and a technique called hydrodissection performed with precise new mechanical syringes to inject the joint, the patient experiences less pain, improved safety, a better response to medications, and less need for other medical therapy," says Dr. Sibbitt. "Rheumatologists are increasingly using ultrasound, and patients should be aware that joint injections may be more effective and less painful if their physician offers this option to them."
Patients should talk to their rheumatologists to determine their best course of treatment.
Source: American College of Rheumatology (ACR)
A Pathway Discovered To Turn Off Immune System Cells
University of Minnesota researchers have discovered a new way to turn genes off in human T cells, a type of white blood cell that helps the immune system fight infections.
Turning off genes, through a process known as mRNA decay, is important for regulating the body's immune response after fighting infection. This research could lead to development of new drugs that turn off the immune system in patients with autoimmune diseases - such as rheumatoid arthritis and lupus. It could also prevent cancer cells from dividing.
Researchers used a novel approach that combines molecular biology and computational analysis to identify mRNA sequence responsible for turning off T cells. The research is published in the February 1 issue of Molecular Cell.
"Although this study analyzed T cells, this pathway is present in all human cells," said Paul Bohjanen, M.D., Ph.D., co-director of the Center for Infectious Diseases and Microbiology Translational Research (CIDMTR) and principal investigator of the study. "Knowledge from this study can be applied to help researchers better understand other types of cells and how they function."
During an infection, T cells turn on and divide to help clear the infection from the body. After the infection is cleared, the cells need to turn off so the body can return to a stable condition. If the cells do not turn off, however, they can cause damage to the body and can potentially develop into cancer cells.
This research is important because to date, understanding the mechanisms that turn off cells has not been very well understood.
Researchers measured the rate of mRNA decay for each of the approximately 6,000 genes in human T cells. That information was then analyzed by George Karypis, Ph.D., associate professor of computer science, and his colleagues at the Minnesota Supercomputing Institute, using complex computer programs to identify a sequence present in mRNA that was destroyed rapidly in the cell. Bohjanen and his colleagues performed molecular biology experiments to confirm that this sequence targets mRNA for destruction and was responsible for turning off genes in activated T cells.
"This discovery would not have been possible without the interdisciplinary collaboration between molecular biologists and computer scientists," Bohjanen said. The collaboration between Bohjanen and Karypis was facilitated by Irina Vlasova, M.D., Ph.D., research associate in Bohjanen's molecular biology laboratory, who received training in computational biology through a Minnesota Supercomputing Institute fellowship.
The research was conducted by researchers at CIDMTR, Department of Microbiology, Department of Medicine, Department of Computer Science, and Division of Biostatistics.
The research was funded by grants from the National Institutes of Health, the Minnesota Medical Foundation, the Minnesota Supercomputing Institute, the Lymphoma Research Foundation, and the Swedish Research Council.
Source: Molly Portz
University of Minnesota
Turning off genes, through a process known as mRNA decay, is important for regulating the body's immune response after fighting infection. This research could lead to development of new drugs that turn off the immune system in patients with autoimmune diseases - such as rheumatoid arthritis and lupus. It could also prevent cancer cells from dividing.
Researchers used a novel approach that combines molecular biology and computational analysis to identify mRNA sequence responsible for turning off T cells. The research is published in the February 1 issue of Molecular Cell.
"Although this study analyzed T cells, this pathway is present in all human cells," said Paul Bohjanen, M.D., Ph.D., co-director of the Center for Infectious Diseases and Microbiology Translational Research (CIDMTR) and principal investigator of the study. "Knowledge from this study can be applied to help researchers better understand other types of cells and how they function."
During an infection, T cells turn on and divide to help clear the infection from the body. After the infection is cleared, the cells need to turn off so the body can return to a stable condition. If the cells do not turn off, however, they can cause damage to the body and can potentially develop into cancer cells.
This research is important because to date, understanding the mechanisms that turn off cells has not been very well understood.
Researchers measured the rate of mRNA decay for each of the approximately 6,000 genes in human T cells. That information was then analyzed by George Karypis, Ph.D., associate professor of computer science, and his colleagues at the Minnesota Supercomputing Institute, using complex computer programs to identify a sequence present in mRNA that was destroyed rapidly in the cell. Bohjanen and his colleagues performed molecular biology experiments to confirm that this sequence targets mRNA for destruction and was responsible for turning off genes in activated T cells.
"This discovery would not have been possible without the interdisciplinary collaboration between molecular biologists and computer scientists," Bohjanen said. The collaboration between Bohjanen and Karypis was facilitated by Irina Vlasova, M.D., Ph.D., research associate in Bohjanen's molecular biology laboratory, who received training in computational biology through a Minnesota Supercomputing Institute fellowship.
The research was conducted by researchers at CIDMTR, Department of Microbiology, Department of Medicine, Department of Computer Science, and Division of Biostatistics.
The research was funded by grants from the National Institutes of Health, the Minnesota Medical Foundation, the Minnesota Supercomputing Institute, the Lymphoma Research Foundation, and the Swedish Research Council.
Source: Molly Portz
University of Minnesota
Scleroderma Dramatically Under-Diagnosed With Commercial Screening Method
New research from Georgetown University Medical Center (GUMC) suggests that up to 40 percent of scleroderma patients will not be correctly diagnosed with the disorder using a new automated commercial screening test. The findings of the study will be presented Wednesday, November 10th at the Annual Scientific Meeting of the American College of Rheumatology in Atlanta, Georgia.
The American College of Rheumatology recommends immunofluorescence antinuclear antibody (IF-ANA) testing to help detect the presence of scleroderma specific antinuclear antibodies. Finding the antibodies is a helpful predictor of disease manifestations, clinical course and outcome in scleroderma. However, many commercial labs have recently adopted a newer, automated method that use non-immunofluorescence antinuclear antibody testing. This test is known as NEW ANA.
To test the accuracy of the commercial method for detecting scleroderma antibodies, GUMC researchers evaluated the all test results performed through commercial laboratories of more than 200 scleroderma patients treated in the Georgetown scleroderma clinic between June 2008 and June 2009.
Test results using NEW ANA were available in 58 scleroderma patients. Twenty-eight patients (48 percent) tested negative. Of these 28 patients, 22 had either positive results using IF-ANA or one of the scleroderma specific antibodies. "The NEW ANA testing, that is the ANA test without immunofluorescence, failed to identify patients with a particular subset of scleroderma specific antinuclear antibodies and other patterns that are picked up with IF ANA testing. This finding was significant," says Victoria K Shanmugam, MBBS, MRCP, assistant professor in the Division of Rheumatology, Immunology and Allergy who presented the findings.
NEW ANA test results were not available for the remaining 183 scleroderma patients. IF ANA testing was conducted in these patients and the positive antibody results were divided by subtypes.
"Given what we know about the subsets that are not detected by the NEW ANA testing, it appears that as many as 40 percent of the scleroderma patients would have tested negative using the new commercial testing method," Shanmugam says. "If a clinician has clinical suspicion for scleroderma, they should order the immunofluorescent ANA."
Notes:
Shanmugam's research is funded by the American College of Rheumatology, Research and Education Foundation, Physician Scientist Development Award and from the National Center for Research Resources.
The authors report no potential financial interests.
Source:
Karen Mallet
Georgetown University Medical Center
The American College of Rheumatology recommends immunofluorescence antinuclear antibody (IF-ANA) testing to help detect the presence of scleroderma specific antinuclear antibodies. Finding the antibodies is a helpful predictor of disease manifestations, clinical course and outcome in scleroderma. However, many commercial labs have recently adopted a newer, automated method that use non-immunofluorescence antinuclear antibody testing. This test is known as NEW ANA.
To test the accuracy of the commercial method for detecting scleroderma antibodies, GUMC researchers evaluated the all test results performed through commercial laboratories of more than 200 scleroderma patients treated in the Georgetown scleroderma clinic between June 2008 and June 2009.
Test results using NEW ANA were available in 58 scleroderma patients. Twenty-eight patients (48 percent) tested negative. Of these 28 patients, 22 had either positive results using IF-ANA or one of the scleroderma specific antibodies. "The NEW ANA testing, that is the ANA test without immunofluorescence, failed to identify patients with a particular subset of scleroderma specific antinuclear antibodies and other patterns that are picked up with IF ANA testing. This finding was significant," says Victoria K Shanmugam, MBBS, MRCP, assistant professor in the Division of Rheumatology, Immunology and Allergy who presented the findings.
NEW ANA test results were not available for the remaining 183 scleroderma patients. IF ANA testing was conducted in these patients and the positive antibody results were divided by subtypes.
"Given what we know about the subsets that are not detected by the NEW ANA testing, it appears that as many as 40 percent of the scleroderma patients would have tested negative using the new commercial testing method," Shanmugam says. "If a clinician has clinical suspicion for scleroderma, they should order the immunofluorescent ANA."
Notes:
Shanmugam's research is funded by the American College of Rheumatology, Research and Education Foundation, Physician Scientist Development Award and from the National Center for Research Resources.
The authors report no potential financial interests.
Source:
Karen Mallet
Georgetown University Medical Center
Researcher Honored For His Long-Time Service To The International Osteoporosis Foundation
Professor Jean-Yves Reginster of Belgium, a founding member of the IOF Board and IOF General Secretary from 1998 to 2007, was awarded the prestigious Pierre Delmas Award.
The award was presented by Professor Cyrus Cooper, Chair of the IOF Committee of Scientific Advisors, at an award ceremony held at the opening of the ECCEO9-IOF Meeting in Athens on March 18, 2009.
The award, formerly known as the IOF President's award, was renamed in memory of the late Pierre D. Delmas, IOF's renowned founding president who passed away in July 2008. At the presentation of the award, Professor Cooper stated, "This award is given to an individual who has made a significant and unstinting contribution to the advancement of the work of the International Osteoporosis Foundation. Jean-Yves Reginster has been instrumental in the creation and growth of IOF, placing his great expertise in the service of IOF and the osteoporosis community as a whole."
Jean-Yves Reginster is currently Professor of Epidemiology, Public Health and Health Economics at the University of Li??ge, Belgium. He is also President of the Department. of Public Health Sciences and Director of the Bone and Cartilage Research Unit at the University Hospital of Li??ge. As an active researcher, Professor Reginster has authored more than 500 publications, mainly dedicated to the pathophysiology of osteoarthritis, epidemiology of osteoporosis and arthritis, health economics, clinical management of osteoporosis and osteoarthritis. Among his other professional activities, Professor Reginster is General Secretary of the Belgium Bone Club, President of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) and President of the Group for the Respect of Ethics and Excellence in Sciences (GREES).
Notes:
Osteoporosis, in which the bones become porous and break easily, is one of the world's most common and debilitating diseases. The result: pain, loss of movement, inability to perform daily chores, and in many cases, death. Around the world, one out of three women over 50 will experience osteoporotic fractures, as will one out of five men (1,2,3). Osteoporosis can, to a certain extent, be prevented, it can be easily diagnosed and effective treatments are available. Nevertheless many people with osteoporosis and at risk of fracture remain undiagnosed and do not receive treatment.
The International Osteoporosis Foundation (IOF) is the only worldwide organization dedicated to the fight against osteoporosis. It brings together scientists, physicians, patient societies and corporate partners. Working with its 191 member patient and medical societies in 91 locations, and other healthcare-related organizations around the world, IOF encourages awareness and prevention, early detection and improved treatment of osteoporosis. Visit iofbonehealth for further information.
Melton U, Chrischilles EA, Cooper C et al. How many women have osteoporosis? Journal of Bone Mineral Research, 1992; 7:1005-10
Kanis JA et al. Long-term risk of osteoporotic fracture in Malmo. Osteoporos Int, 2000; 11:669-674
Melton LJ, et al. Bone density and fracture risk in men. JBMR. 1998; 13: No 12:1915
For more information on osteoporosis and IOF please visit: iofbonehealth
Source: Laura Misteli
International Osteoporosis Foundation
The award was presented by Professor Cyrus Cooper, Chair of the IOF Committee of Scientific Advisors, at an award ceremony held at the opening of the ECCEO9-IOF Meeting in Athens on March 18, 2009.
The award, formerly known as the IOF President's award, was renamed in memory of the late Pierre D. Delmas, IOF's renowned founding president who passed away in July 2008. At the presentation of the award, Professor Cooper stated, "This award is given to an individual who has made a significant and unstinting contribution to the advancement of the work of the International Osteoporosis Foundation. Jean-Yves Reginster has been instrumental in the creation and growth of IOF, placing his great expertise in the service of IOF and the osteoporosis community as a whole."
Jean-Yves Reginster is currently Professor of Epidemiology, Public Health and Health Economics at the University of Li??ge, Belgium. He is also President of the Department. of Public Health Sciences and Director of the Bone and Cartilage Research Unit at the University Hospital of Li??ge. As an active researcher, Professor Reginster has authored more than 500 publications, mainly dedicated to the pathophysiology of osteoarthritis, epidemiology of osteoporosis and arthritis, health economics, clinical management of osteoporosis and osteoarthritis. Among his other professional activities, Professor Reginster is General Secretary of the Belgium Bone Club, President of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) and President of the Group for the Respect of Ethics and Excellence in Sciences (GREES).
Notes:
Osteoporosis, in which the bones become porous and break easily, is one of the world's most common and debilitating diseases. The result: pain, loss of movement, inability to perform daily chores, and in many cases, death. Around the world, one out of three women over 50 will experience osteoporotic fractures, as will one out of five men (1,2,3). Osteoporosis can, to a certain extent, be prevented, it can be easily diagnosed and effective treatments are available. Nevertheless many people with osteoporosis and at risk of fracture remain undiagnosed and do not receive treatment.
The International Osteoporosis Foundation (IOF) is the only worldwide organization dedicated to the fight against osteoporosis. It brings together scientists, physicians, patient societies and corporate partners. Working with its 191 member patient and medical societies in 91 locations, and other healthcare-related organizations around the world, IOF encourages awareness and prevention, early detection and improved treatment of osteoporosis. Visit iofbonehealth for further information.
Melton U, Chrischilles EA, Cooper C et al. How many women have osteoporosis? Journal of Bone Mineral Research, 1992; 7:1005-10
Kanis JA et al. Long-term risk of osteoporotic fracture in Malmo. Osteoporos Int, 2000; 11:669-674
Melton LJ, et al. Bone density and fracture risk in men. JBMR. 1998; 13: No 12:1915
For more information on osteoporosis and IOF please visit: iofbonehealth
Source: Laura Misteli
International Osteoporosis Foundation
Despite Recent Progress, More Action Needed To Prevent Stomach Problems In NSAID Users
Four out of ten high-risk patients prescribed nonsteroidal anti-inflammatory drugs (NSAIDs) also received appropriate measures to prevent upper-gastrointestinal (UGI) problems, but the remainder did not receive adequate protection, according to a study in the June issue of Alimentary Pharmacology and Therapeutics.
Although the number of patients receiving preventative strategies increased five-fold over the 11-year period studied by researchers in The Netherlands, greater steps need to be taken to protect patients who face a high risk of side effects.
"NSAIDs are among the world's most frequently prescribed drugs for arthritis and inflammatory conditions, but their use can quadruple the risk of upper gastrointestinal problems" explains lead researcher Dr Vera Valkhoff from the Erasmus University Medical Centre in Rotterdam.
"These can range from mild symptoms like indigestion to more serious conditions like bleeding, perforation or obstructions, which can lead to hospital admissions or, in some cases, death.
"Preventative strategies include using a COX inhibitor NSAID instead of a nonselective NSAID and combining NSAIDs with gastroprotective agents. However international studies suggest that as many as three-quarters of high- risk patients are not receiving adequate protection from the side effects of NSAIDs."
The research team looked at the records of 50,126 NSAID users aged 50 or over from the Integrated Primary Care Database, using the latest figures available (1996 to 2006).
This showed that just under seven per cent of high-risk patients had been correctly prescribed preventative strategies in 1996, but by 2006 this had risen to over 39 per cent. However, the latest figure was nine per cent higher for patients who had a medical history of UGI problems.
A correct prescription was defined as a patient receiving a preventative strategy if they were defined as high risk because of a history of UGI bleeding/ulceration, being 65 or over or using anticoagulants, aspirin or corticosteroids. This category also included low-risk patients who were not receiving a preventative strategy, as there is no indication that this is necessary in such cases.
Under-prescription was defined as a high-risk patient not receiving a strategy and over prescription as a low-risk patient receiving a strategy.
Key findings of the study include:
Just over 43 per cent of NSAID users were defined as high-risk because of at least one risk factor. Being aged 65 or over was the most frequent risk factor (40 per cent) followed by use of anticoagulants (nine per cent) and having diabetes mellitus (eight per cent).
The researchers found that the remaining 57 per cent of the study population had no NSAID-related upper-gastrointestinal (UGI) risk factors and were therefore deemed as low risk.
Correct prescriptions among high-risk users rose from seven per cent in 1996 to 39 per cent in 2006. But the number of low-risk users who received unnecessary preventative strategies also rose, from three per cent in 1996 to 12 per cent in 2006.
Preventative strategies for patients with a medical history of UGI events rose from 27 per cent in 1996 to 48 per cent in 2006. When older age was factored in (75 plus) these figures rose from nine per cent in 1996 to 49 per cent in 2006.
High-risk patients had a higher average age than low-risk patients (73 versus 55.6 years) and were more likely to be female than male (60 per cent versus 54 per cent).
"Our study shows that, although considerable improvements have been made in prescribing preventative strategies for people taking NSAIDs, the majority of high-risk users, including those with a history of UGI events, are not receiving adequate protection from side effects.
"We hope that our study will draw attention to the international need for patient risk to be evaluated and appropriate action taken to ensure that NSAID use does not lead to UGI problems."
Notes:
Time-trends in gastroprotection with nonsteroidal anti-inflammatory drugs (NSAIDS). Valkhoff et al. Alimentary Pharmacology & Therapeutics. 31, pp1218-1228. (June 2010). DOI: 10.1111/j.1365-2036.2010.04281.x
Source:
Annette Whibley
Wiley-Blackwell
Although the number of patients receiving preventative strategies increased five-fold over the 11-year period studied by researchers in The Netherlands, greater steps need to be taken to protect patients who face a high risk of side effects.
"NSAIDs are among the world's most frequently prescribed drugs for arthritis and inflammatory conditions, but their use can quadruple the risk of upper gastrointestinal problems" explains lead researcher Dr Vera Valkhoff from the Erasmus University Medical Centre in Rotterdam.
"These can range from mild symptoms like indigestion to more serious conditions like bleeding, perforation or obstructions, which can lead to hospital admissions or, in some cases, death.
"Preventative strategies include using a COX inhibitor NSAID instead of a nonselective NSAID and combining NSAIDs with gastroprotective agents. However international studies suggest that as many as three-quarters of high- risk patients are not receiving adequate protection from the side effects of NSAIDs."
The research team looked at the records of 50,126 NSAID users aged 50 or over from the Integrated Primary Care Database, using the latest figures available (1996 to 2006).
This showed that just under seven per cent of high-risk patients had been correctly prescribed preventative strategies in 1996, but by 2006 this had risen to over 39 per cent. However, the latest figure was nine per cent higher for patients who had a medical history of UGI problems.
A correct prescription was defined as a patient receiving a preventative strategy if they were defined as high risk because of a history of UGI bleeding/ulceration, being 65 or over or using anticoagulants, aspirin or corticosteroids. This category also included low-risk patients who were not receiving a preventative strategy, as there is no indication that this is necessary in such cases.
Under-prescription was defined as a high-risk patient not receiving a strategy and over prescription as a low-risk patient receiving a strategy.
Key findings of the study include:
Just over 43 per cent of NSAID users were defined as high-risk because of at least one risk factor. Being aged 65 or over was the most frequent risk factor (40 per cent) followed by use of anticoagulants (nine per cent) and having diabetes mellitus (eight per cent).
The researchers found that the remaining 57 per cent of the study population had no NSAID-related upper-gastrointestinal (UGI) risk factors and were therefore deemed as low risk.
Correct prescriptions among high-risk users rose from seven per cent in 1996 to 39 per cent in 2006. But the number of low-risk users who received unnecessary preventative strategies also rose, from three per cent in 1996 to 12 per cent in 2006.
Preventative strategies for patients with a medical history of UGI events rose from 27 per cent in 1996 to 48 per cent in 2006. When older age was factored in (75 plus) these figures rose from nine per cent in 1996 to 49 per cent in 2006.
High-risk patients had a higher average age than low-risk patients (73 versus 55.6 years) and were more likely to be female than male (60 per cent versus 54 per cent).
"Our study shows that, although considerable improvements have been made in prescribing preventative strategies for people taking NSAIDs, the majority of high-risk users, including those with a history of UGI events, are not receiving adequate protection from side effects.
"We hope that our study will draw attention to the international need for patient risk to be evaluated and appropriate action taken to ensure that NSAID use does not lead to UGI problems."
Notes:
Time-trends in gastroprotection with nonsteroidal anti-inflammatory drugs (NSAIDS). Valkhoff et al. Alimentary Pharmacology & Therapeutics. 31, pp1218-1228. (June 2010). DOI: 10.1111/j.1365-2036.2010.04281.x
Source:
Annette Whibley
Wiley-Blackwell
Patients Better Prepared For Knee Replacement Surgery By Prehabilitation
An exercise program designed by researchers at the University of Louisville for patients with severe knee arthritis improves leg strength and patients' functional ability before knee replacement surgery, according to recent report in The Journal of Strength and Conditioning Research.
The study, led by UofL's Ann Swank, Ph.D., CSCS, and Robert Topp, Ph.D., R.N., says gains from exercise before knee replacement or prehabilitation may translate into improved recovery after surgery.
"We designed this program to be easily transferred to a home environment," Swank said. "It is very possible for many patients preparing for knee replacement surgery to participate in this exercise program and experience increased strength and functionality such as getting up from a chair or climbing stairs."
However, Swank noted the prehabilitation program did not significantly improve functional tasks such as walking speed or going downstairs.
The study included 71 patients scheduled for knee replacement surgery because of severe osteoarthritis that could not be managed with pain medications. Osteoarthritis of the knee is a very common condition in older adults, causing pain and gradual declines in the ability to perform everyday tasks. When pain becomes so severe that medications no longer provide relief, knee replacement surgery is the only option. By that time, reduced leg strength may be present for several years - not only decreasing functional ability, but increasing the risk of falls.
One group of participants was randomly assigned to a comprehensive prehabilitation program, consisting of light resistance training, flexibility and step exercise, and light walking.
Patients in this "pre-rehab" group exercised three times per week, in the clinic and at home, for four to eight weeks before knee replacement surgery. Patients in the comparison group received standard preoperative care, with instructions to continue their usual activities. The two groups were compared for knee strength and performance on standard functional tests.
When tested one week before surgery, patients who went through the prehabilitation program showed improvements in several areas. In particular, they had a 10 percent increase in extension strength in the leg scheduled for knee replacement. In contrast, the comparison group had a 10 percent decrease in extension strength.
In addition, patients in the prehabilitation group had less pain when performing the functional tests. For patients receiving standard care, performance on some functional tests actually decreased in the weeks before surgery - possibly reflecting increased pain scores.
The results show significant improvements in strength and functioning in the weeks before knee replacement surgery. Strengthening of the leg undergoing knee replacement may be a particularly important factor - exercise may reduce the strength imbalance between legs, therefore contributing to the functional improvement. The researchers do note that even with exercise, the surgical leg remains significantly weaker than the other leg.
Previous studies have evaluated exercise programs to improve leg strength and functional ability before knee replacement surgery, but with limited success.
Although the study did not compare postoperative recovery, increases in leg strength and performance of functional tasks before knee replacement surgery may result in improved postoperative recovery because preoperative performance of functional tasks has been shown to be a predictor of postoperative performance of functional tasks, Swank said.
Topp noted that in addition to the clinical aspects, there is the potential for cost-savings as well.
"The next step in this research is to determine whether this comprehensive prehabilitation exercise program translates to a savings in healthcare dollars," Topp said. "For example, reducing the number of days a patient stays in the hospital or reducing the number of physical therapy sessions."
Notes:
Several other University of Louisville faculty also contributed to the study, "Prehabilitaion Before Total Knee Arthroplasty Increases Strength and Function in Older Adults With Severe Osteoarthritis."
Source:
Julie Heflin
University of Louisville
The study, led by UofL's Ann Swank, Ph.D., CSCS, and Robert Topp, Ph.D., R.N., says gains from exercise before knee replacement or prehabilitation may translate into improved recovery after surgery.
"We designed this program to be easily transferred to a home environment," Swank said. "It is very possible for many patients preparing for knee replacement surgery to participate in this exercise program and experience increased strength and functionality such as getting up from a chair or climbing stairs."
However, Swank noted the prehabilitation program did not significantly improve functional tasks such as walking speed or going downstairs.
The study included 71 patients scheduled for knee replacement surgery because of severe osteoarthritis that could not be managed with pain medications. Osteoarthritis of the knee is a very common condition in older adults, causing pain and gradual declines in the ability to perform everyday tasks. When pain becomes so severe that medications no longer provide relief, knee replacement surgery is the only option. By that time, reduced leg strength may be present for several years - not only decreasing functional ability, but increasing the risk of falls.
One group of participants was randomly assigned to a comprehensive prehabilitation program, consisting of light resistance training, flexibility and step exercise, and light walking.
Patients in this "pre-rehab" group exercised three times per week, in the clinic and at home, for four to eight weeks before knee replacement surgery. Patients in the comparison group received standard preoperative care, with instructions to continue their usual activities. The two groups were compared for knee strength and performance on standard functional tests.
When tested one week before surgery, patients who went through the prehabilitation program showed improvements in several areas. In particular, they had a 10 percent increase in extension strength in the leg scheduled for knee replacement. In contrast, the comparison group had a 10 percent decrease in extension strength.
In addition, patients in the prehabilitation group had less pain when performing the functional tests. For patients receiving standard care, performance on some functional tests actually decreased in the weeks before surgery - possibly reflecting increased pain scores.
The results show significant improvements in strength and functioning in the weeks before knee replacement surgery. Strengthening of the leg undergoing knee replacement may be a particularly important factor - exercise may reduce the strength imbalance between legs, therefore contributing to the functional improvement. The researchers do note that even with exercise, the surgical leg remains significantly weaker than the other leg.
Previous studies have evaluated exercise programs to improve leg strength and functional ability before knee replacement surgery, but with limited success.
Although the study did not compare postoperative recovery, increases in leg strength and performance of functional tasks before knee replacement surgery may result in improved postoperative recovery because preoperative performance of functional tasks has been shown to be a predictor of postoperative performance of functional tasks, Swank said.
Topp noted that in addition to the clinical aspects, there is the potential for cost-savings as well.
"The next step in this research is to determine whether this comprehensive prehabilitation exercise program translates to a savings in healthcare dollars," Topp said. "For example, reducing the number of days a patient stays in the hospital or reducing the number of physical therapy sessions."
Notes:
Several other University of Louisville faculty also contributed to the study, "Prehabilitaion Before Total Knee Arthroplasty Increases Strength and Function in Older Adults With Severe Osteoarthritis."
Source:
Julie Heflin
University of Louisville
Supporting Expanded Analyses Of The 510(k) Product Review Process, Lifetime Benefits Of Implantable Devices
The Institute for Health Technology Studies (InHealth) has awarded two follow-on grants totaling more than $830,000 to research teams at Northwestern University and Duke University.
Northwestern investigators will study opportunities for improving the Food and Drug Administration's 510(k) product review process for medical devices. The work builds on previous InHealth-funded research that for the first time documented in detail the medical technology development process.
Duke researchers will focus on the lifetime benefits of implantable devices, including replacement knees and hips, and cardiac pacemakers. This research will add to the Duke team's previously published analyses of the shorter-term impacts of total knee and total hip replacement procedures.
"Evidence-based policy is at the center of the new healthcare landscape, placing even more importance on measuring the effects of medical technology," said Martyn Howgill, InHealth's executive director. "InHealth's continued support of faculty teams at Northwestern and Duke offers the opportunity for these accomplished researchers to build much-needed evidence about the regulation and lifetime benefits of medical devices to ensure that future policy decisions save, improve, and extend lives."
Northwestern University: Measuring the Effectiveness of the 510(k) Process
The Northwestern team will receive $240,000 for a new study, "A Comprehensive Analysis of the FDA 510(k) Process: Industry Practice and the Implications for Reform." The team will undertake a systematic collection of information, data, and constructive input from those who participate in the 510(k) process and know it best - those involved in the design and development of regulated medical products, including entrepreneurs, academic physician-inventors, and federal regulators. The study will extend research funded by an InHealth grant awarded in 2006.
The Northwestern study team is led by principal investigator John H. Linehan, PhD, professor of medicine and biomedical engineering and director of the center for translational innovation at the Northwestern University Clinical and Translational Science Institute. Collaborating on the study will be Jan B. Pietzsch, PhD, consulting associate professor of management science and engineering, advisory faculty member of the Biodesign program at Stanford University, and president and CEO, Wing Tech Inc.
The grant coincides with heightened debate surrounding FDA's plans to revamp the 510(k) product review process, which permits companies to make new products commercially available when they are "substantially equivalent" to a predicate device already on the market. The process governs Class II products, which make up the vast majority of medical devices cleared for market entry each year.
"Healthcare reform has brought the 510(k) process under increased scrutiny, transforming a decades-old process into a hot-button issue," Howgill said. "Critics of the process are concerned about patient safety and supporters worry that overhaul will disrupt the industry and innovation. Any reform must be based on unbiased evidence about the effectiveness of the process itself."
Duke University: Examining the Impact of Hips, Knees, and Pacemakers
The Duke team will be led by co-principal investigators Linda George, PhD, professor of sociology and associate director of the center for the study of aging, and Frank Sloan, PhD, J. Alexander McMahon professor of health policy and management and professor of economics. The team will receive nearly $600,000 over three years for "Assessing the Impact of Implantable Medical Devices on Disability, Health, and Medicare Expenditures," which will explore the effects of three commonly used implantable medical devices - total knee and hip replacement systems, and cardiac pacemakers - on multiple outcomes, including disability rates, changes in comorbidities, and the recipient's total Medicare expenditures.
According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases, approximately 773,000 Americans undergo knee- or hip-replacement surgery each year. Researchers will measure how these orthopedic devices have contributed to the decline in elderly disability over the past quarter century. They will also explore the lifetime benefits of joint replacement devices for patients, including physical functioning; the onset or worsening of comorbid conditions such as diabetes and obesity; and the impact of joint replacements on Medicare expenditures and personal and institutional care costs. This analysis will also be applied to implantable cardiac pacemakers.
The new study builds on the team's previous research, which demonstrated that, in the short-term, total knee- and hip-replacement systems lessened disability for the elderly at any age. Findings will shed light on how these devices impact both the economy and patients - an issue at the center of healthcare reform implementation.
The two follow-on grants support InHealth's mission to measure the effects of advanced medical technologies. Since its establishment in 2004, InHealth has invested more than $11 million in research-related activities, including grants to Duke University, Harvard/Beth Israel Deaconess Medical Center, Johns Hopkins University, Medical College of Georgia, Northwestern University, Stanford University, Tufts University, the University of Houston, the University of Pennsylvania, and the University of Southern California.
Source:
Caitlin Hool
InHealth: The Institute for Health Technology Studies
Northwestern investigators will study opportunities for improving the Food and Drug Administration's 510(k) product review process for medical devices. The work builds on previous InHealth-funded research that for the first time documented in detail the medical technology development process.
Duke researchers will focus on the lifetime benefits of implantable devices, including replacement knees and hips, and cardiac pacemakers. This research will add to the Duke team's previously published analyses of the shorter-term impacts of total knee and total hip replacement procedures.
"Evidence-based policy is at the center of the new healthcare landscape, placing even more importance on measuring the effects of medical technology," said Martyn Howgill, InHealth's executive director. "InHealth's continued support of faculty teams at Northwestern and Duke offers the opportunity for these accomplished researchers to build much-needed evidence about the regulation and lifetime benefits of medical devices to ensure that future policy decisions save, improve, and extend lives."
Northwestern University: Measuring the Effectiveness of the 510(k) Process
The Northwestern team will receive $240,000 for a new study, "A Comprehensive Analysis of the FDA 510(k) Process: Industry Practice and the Implications for Reform." The team will undertake a systematic collection of information, data, and constructive input from those who participate in the 510(k) process and know it best - those involved in the design and development of regulated medical products, including entrepreneurs, academic physician-inventors, and federal regulators. The study will extend research funded by an InHealth grant awarded in 2006.
The Northwestern study team is led by principal investigator John H. Linehan, PhD, professor of medicine and biomedical engineering and director of the center for translational innovation at the Northwestern University Clinical and Translational Science Institute. Collaborating on the study will be Jan B. Pietzsch, PhD, consulting associate professor of management science and engineering, advisory faculty member of the Biodesign program at Stanford University, and president and CEO, Wing Tech Inc.
The grant coincides with heightened debate surrounding FDA's plans to revamp the 510(k) product review process, which permits companies to make new products commercially available when they are "substantially equivalent" to a predicate device already on the market. The process governs Class II products, which make up the vast majority of medical devices cleared for market entry each year.
"Healthcare reform has brought the 510(k) process under increased scrutiny, transforming a decades-old process into a hot-button issue," Howgill said. "Critics of the process are concerned about patient safety and supporters worry that overhaul will disrupt the industry and innovation. Any reform must be based on unbiased evidence about the effectiveness of the process itself."
Duke University: Examining the Impact of Hips, Knees, and Pacemakers
The Duke team will be led by co-principal investigators Linda George, PhD, professor of sociology and associate director of the center for the study of aging, and Frank Sloan, PhD, J. Alexander McMahon professor of health policy and management and professor of economics. The team will receive nearly $600,000 over three years for "Assessing the Impact of Implantable Medical Devices on Disability, Health, and Medicare Expenditures," which will explore the effects of three commonly used implantable medical devices - total knee and hip replacement systems, and cardiac pacemakers - on multiple outcomes, including disability rates, changes in comorbidities, and the recipient's total Medicare expenditures.
According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases, approximately 773,000 Americans undergo knee- or hip-replacement surgery each year. Researchers will measure how these orthopedic devices have contributed to the decline in elderly disability over the past quarter century. They will also explore the lifetime benefits of joint replacement devices for patients, including physical functioning; the onset or worsening of comorbid conditions such as diabetes and obesity; and the impact of joint replacements on Medicare expenditures and personal and institutional care costs. This analysis will also be applied to implantable cardiac pacemakers.
The new study builds on the team's previous research, which demonstrated that, in the short-term, total knee- and hip-replacement systems lessened disability for the elderly at any age. Findings will shed light on how these devices impact both the economy and patients - an issue at the center of healthcare reform implementation.
The two follow-on grants support InHealth's mission to measure the effects of advanced medical technologies. Since its establishment in 2004, InHealth has invested more than $11 million in research-related activities, including grants to Duke University, Harvard/Beth Israel Deaconess Medical Center, Johns Hopkins University, Medical College of Georgia, Northwestern University, Stanford University, Tufts University, the University of Houston, the University of Pennsylvania, and the University of Southern California.
Source:
Caitlin Hool
InHealth: The Institute for Health Technology Studies
Подписаться на:
Комментарии (Atom)