Physicians should avoid prescribing Bextra altogether, or use it only as a drug of last resort, says a researcher from
Wake Forest University Baptist Medical Center and colleagues in an editorial published on-line Jan. 17 in Circulation, a
publication of the American Heart Association.
Curt D. Furberg, M.D., Ph.D., professor of public health sciences, and colleagues describe an analysis of two studies
revealed that patients treated with Bextra after heart bypass surgery tripled their risk of heart attack and stroke compared
to patients who received a placebo, or "dummy" drug. The data is a followup to information reported at the American Heart
Association meeting in November.
"These data raise questions about the safety of the drug in other patients who have heart conditions, but who aren't having
surgery," said Furberg. "In the absence of evidence of safety, it is prudent to avoid the use of Bextra altogether or use it
only as a drug of last resort," says the editorial. Furberg's co-authors are Bruce M. Psaty, M.D., Ph.D., from the University
of Washington in Seattle, and Garret A. FitzGerald, M.D., from the University of Pennsylvania.
The researchers say the Bextra results, combined with studies showing cardiovascular hazards with Celebrex and Vioxx,
"provide compelling evidence that these adverse coronary and cerebrovascular events represent a class effect…" The drugs are
all part of a class called COX-2 inhibitors.
"A black-box warning that alerts practitioners to the potential cardiovascular hazards, especially in patients at moderate to
high risk, seems timely for all COX-2 inhibitors," said Psaty.
Furberg supports the advice of the Food and Drug Administration, which issued a Public Health Advisory on COX-2 inhibitors
and other non-steroidal anti-inflammatory drug products urging physicians to weigh the benefits against the risk for
individual patients.
In the editorial, the authors support research to learn whether the drugs can be safely given for extended periods to
patients at low risk of cardiovascular disease.
"It is currently unclear to what degree the risk extends to patients treated with lower doses for arthritis because studies
of sufficient size and duration have not been reported," Furberg said.
FitzGerald, who has been studying COX-2 inhibitors for more than six years, says that plans by Pfizer to study potential
cardiovascular benefits of Celebrex are ill-advised.
In a separate article in Circulation, FitzGerald and colleagues report on evidence from mice showing that the combination of
aspirin and a COX-2 inhibitor could make plaque in the arteries more likely to rupture and cause clotting, resulting in heart
attack or stroke.
"These results have disturbing implications for patients at high cardiovascular risk treated with aspirin and a COX
inhibitor," writes FitzGerald.
Media Contacts: Karen Richardson, krchrdsnwfubmc; Shannon Koontz, shkoontzwfubmc; at 336-716-4587
About Wake Forest University Baptist Medical Center:
Wake Forest Baptist is an academic health system comprised of North Carolina Baptist Hospital and Wake Forest University
Health Sciences, which operates the university's School of Medicine. The system comprises 1,282 acute care, psychiatric,
rehabilitation and long-term care beds.
Karen Richardson
krchrdsnwfubmc
Wake Forest University Baptist Medical Center
View drug information on Bextra; Vioxx.
вторник, 9 августа 2011 г.
суббота, 6 августа 2011 г.
New Study Links Inflammation To Plaque Buildup In The Arteries Of People With Rheumatoid Arthritis
New data presented this week at the American College of Rheumatology Annual Scientific Meeting in Atlanta show that systemic inflammation and rheumatoid arthritis disease activity may contribute to the progression of atherosclerosis in people with RA. The data also show that this progression may be modified favorably by TNF inhibitors and detrimentally by glucocorticoids.
"These data suggest that by limiting inflammation in RA patients, you can potentially limit the rapidity of accumulation of at least carotid atherosclerosis, which is what our study looked at," says Jon T. Giles, MD, MPH; assistant professor of medicine in the Division of Rheumatology at Johns Hopkins and lead investigator in the study. "And because carotid atherosclerosis tends to be correlated with coronary atherosclerosis, then potentially you would have fewer cardiovascular events like myocardial infarction and stroke in RA patients. These links with subclinical atherosclerosis make intuitive sense, but they haven't [previously] been shown in prospective studies."
Rheumatoid arthritis is a chronic disease that causes pain, stiffness, swelling, and limitation in the motion and function of multiple joints. Though joints are the principal body parts affected by RA, inflammation can develop in other organs as well. An estimated 1.3 million Americans have RA, and the disease typically affects women twice as often as men.
Coronary and extra-coronary atherosclerosis the buildup of plaque in the artery walls are increased in people with RA, when compared to people without the disease. However, few studies have explored predictors of change in atherosclerosis in RA patients. In a study funded in part by the ACR Research and Education Foundation, researchers recently addressed this by following 158 people with RA who were already enrolled in a study of cardiovascular disease in RA.
They focused on monitoring intima-medial thickness the thickness of artery walls that is used in diagnosing atherosclerosis. Participants underwent an ultrasound of their common and internal carotid arteries (arteries that provide blood to the head and neck) at the first and third study visits, which were an average of 3.2 years apart. Through this, researchers found that the thickness of the common carotid artery walls increased over time in 82 percent of the participants and the thickness in the internal carotid artery walls increased in 70 percent of the participants.
When the researchers adjusted their data to consider demographics, cardiovascular risk factors, and the thickness of the carotid artery walls at the beginning of the study, they found that those participants who used anti-TNF treatment at the beginning of the study had a 37 percent lower rate of progression of the thickness of the common carotid artery walls than those who did not use anti-TNF treatment. They also noted that the adjusted average yearly change in the thickness of the common carotid artery walls was significantly higher for patients earlier in their RA when compared to those who had the disease longer.
When looking at thickness in the internal carotid artery walls, prednisone exposure was the only RA feature researchers associated with progression of atherosclerosis after adjusting the data to consider demographics, cardiovascular risk factors and thickness of the internal carotid artery walls at the beginning of the study. And, this rate was significantly lower in participants who were prescribed statins at the beginning of the study.
"There seem to be some medications used in RA that can either be protective or can promote atherosclerosis," Dr. Giles says. "Prednisone may be more associated with progression of atherosclerosis in some vascular beds, but medications like TNF inhibitors and statins that are taken to lower cholesterol may limit atherosclerosis in these patients."
Finally, researchers noted that those participants with a higher than average number of swollen joints and a higher than average c-reactive protein were independently and significantly associated with incidence of plaque.
The next step for researchers is to conduct interventional studies that randomize patients to receive one medication or another and determine the direct cause-and-effect relationship between the medications and the progression of atherosclerosis, either in coronary artery circulation or the carotid artery circulation.
"Those studies are in the planning stages," Dr. Giles says. "They are big studies and hard to organize, but they're really required to determine what the role of the medications are in terms of protection."
Source: American College of Rheumatology (ACR)
"These data suggest that by limiting inflammation in RA patients, you can potentially limit the rapidity of accumulation of at least carotid atherosclerosis, which is what our study looked at," says Jon T. Giles, MD, MPH; assistant professor of medicine in the Division of Rheumatology at Johns Hopkins and lead investigator in the study. "And because carotid atherosclerosis tends to be correlated with coronary atherosclerosis, then potentially you would have fewer cardiovascular events like myocardial infarction and stroke in RA patients. These links with subclinical atherosclerosis make intuitive sense, but they haven't [previously] been shown in prospective studies."
Rheumatoid arthritis is a chronic disease that causes pain, stiffness, swelling, and limitation in the motion and function of multiple joints. Though joints are the principal body parts affected by RA, inflammation can develop in other organs as well. An estimated 1.3 million Americans have RA, and the disease typically affects women twice as often as men.
Coronary and extra-coronary atherosclerosis the buildup of plaque in the artery walls are increased in people with RA, when compared to people without the disease. However, few studies have explored predictors of change in atherosclerosis in RA patients. In a study funded in part by the ACR Research and Education Foundation, researchers recently addressed this by following 158 people with RA who were already enrolled in a study of cardiovascular disease in RA.
They focused on monitoring intima-medial thickness the thickness of artery walls that is used in diagnosing atherosclerosis. Participants underwent an ultrasound of their common and internal carotid arteries (arteries that provide blood to the head and neck) at the first and third study visits, which were an average of 3.2 years apart. Through this, researchers found that the thickness of the common carotid artery walls increased over time in 82 percent of the participants and the thickness in the internal carotid artery walls increased in 70 percent of the participants.
When the researchers adjusted their data to consider demographics, cardiovascular risk factors, and the thickness of the carotid artery walls at the beginning of the study, they found that those participants who used anti-TNF treatment at the beginning of the study had a 37 percent lower rate of progression of the thickness of the common carotid artery walls than those who did not use anti-TNF treatment. They also noted that the adjusted average yearly change in the thickness of the common carotid artery walls was significantly higher for patients earlier in their RA when compared to those who had the disease longer.
When looking at thickness in the internal carotid artery walls, prednisone exposure was the only RA feature researchers associated with progression of atherosclerosis after adjusting the data to consider demographics, cardiovascular risk factors and thickness of the internal carotid artery walls at the beginning of the study. And, this rate was significantly lower in participants who were prescribed statins at the beginning of the study.
"There seem to be some medications used in RA that can either be protective or can promote atherosclerosis," Dr. Giles says. "Prednisone may be more associated with progression of atherosclerosis in some vascular beds, but medications like TNF inhibitors and statins that are taken to lower cholesterol may limit atherosclerosis in these patients."
Finally, researchers noted that those participants with a higher than average number of swollen joints and a higher than average c-reactive protein were independently and significantly associated with incidence of plaque.
The next step for researchers is to conduct interventional studies that randomize patients to receive one medication or another and determine the direct cause-and-effect relationship between the medications and the progression of atherosclerosis, either in coronary artery circulation or the carotid artery circulation.
"Those studies are in the planning stages," Dr. Giles says. "They are big studies and hard to organize, but they're really required to determine what the role of the medications are in terms of protection."
Source: American College of Rheumatology (ACR)
среда, 3 августа 2011 г.
Anoles Key To Medically Applicable Regeneration?
Anolis lizards first entered Arizona State University biologist Kenro Kusumi's life in 1980 when, as a member of a junior curator program, he recorded in his field notebook that he had found an Anolis egg on a field trip. Kusumi still has those notes, along with other memorabilia that document the influence that both his early life and more recent experiences have had on his current pursuits in developmental biology. One such souvenir is a small Pueblo lizard sculpture that sits on a table in his office. With one missing leg and a tail, broken and repaired in two places, it is not particularly eye-catching, but it does symbolize Kusumi's current research model: a lizard which can "fix" or more accurately, regenerate, its broken tail.
Human regeneration is mainly limited to small portions of liver tissue, bone, or muscle, yet understanding how regeneration occurs in other taxonomic groups may enable scientists to improve human regenerative abilities in the future. Kusumi is working to understand the molecular processes that enable some lizards to regenerate their tissues with fellow ASU School of Life Sciences faculty members Jeanne Wilson-Rawls, Allan Rawls, Rebecca Fisher and Dale DeNardo (collectively referred to as "JARKD" by their students). Lizards can regenerate facial bones, certain areas of the spinal cord, and, as is most commonly known, most lizards can regenerate their tail - including muscles, cartilage, and spinal cord. The regenerated tail does not contain bone, but instead is supported by a tube of hyaline cartilage - the same cartilage humans have lining many of their joints. With widespread medical problems such as arthritis and spinal cord injuries, the application of these regenerative abilities is of extreme interest to medical institutions.
"Members of my family have terrible osteoarthritis," Kusumi explains. "That means the cartilage at the joints has degenerated. These lizards can regenerate that kind of cartilage, and they have no problem doing so. How is it that we can't do this, but they can?" With the help of the Anolis model, Kusumi and the rest of the JARKD team are delving into this mystery, recently funded by a $412,606 grant from the National Institutes of Health and a $225,000 grant from the Arizona Biomedical Research Commission.
Many vertebrate and invertebrate species can regenerate tissues, but there are several kinds of regeneration. Lizards most likely use stem-cell mediated regeneration, where new cells involved in regrowth arise from tissue-specific progenitor cells. This type of regeneration is the best bet for a regenerative process compatible with the human system, Kusumi says. Now that the Anolis carolinensis genome is sequenced, rather than trying to solve the puzzle blind, the research team has a view of the bigger picture as a guide to work from.
Molecular methods have improved to the point that the JARKD team is focusing on this question at the perfect time. Kusumi mused, "the beauty is that now we know enough about development that we can actually have candidates for what cells are making this new tail - we can have guesses as to what might be right." Using this candidate approach, Wilson-Rawls and graduate student Rajani George have successfully identified and isolated lizard cells that can make new muscle. Meanwhile, the Kusumi lab is working to uncover what developmental control genes are being expressed in regenerating tails. Here, with collaborators from the Translational Genomics Research Institute (TGen), JARKD is using RNA-Seq, a next-generation technology that allows researchers to take a more unbiased approach, finding all the genes being expressed in a tissue at one point in time. When compared with embryonic development of the tail, which is being investigated by graduate student Walter Eckalbar, differences between initial tissue generation and regenerative processes can be identified. The genes involved in regeneration are likely conserved across various taxonomic classes, but the genetic switches for those genes may be turned off or down. "Once we understand the nuts and bolts of how this is happening, we can use available technologies to manipulate and change that," Kusumi explains, "then we will try to translate that to the mouse model."
A regenerating mouse tail is only one of the many images inspired by Kusumi's Anolis studies. In concert with colleagues at the Smithsonian Tropical Research Institute (STRI) in Panama and Elizabeth Hutchins, one of Kusumi's graduate students, the JARKD team is adopting an evolutionary perspective of various Anolis processes or adaptations. "Occasionally you have a very unique opportunity to look at a natural experiment where one species arrived on one island or was isolated in a region, which then led to the adaptive radiation of many species to fill a variety of niches," Kusumi says. Anolis has in fact been described by some scientists as the "Darwin's finch" of reptiles. This reference points to the number and range of ecomorphs in the Anolis genus, as species have arisen in different regions bearing highly similar behaviors and morphology (also known as convergent evolution). While anoles have been the focus of many evolutionary studies, the JARKD-STRI team is focusing on the intersection of evolution and development, where "you can look for the regulatory changes that drove a limb to be longer or muscles to be more robust."
With such a bright road ahead for both the regenerative and evolutionary undertakings, Kusumi hopes ASU will lead internationally, as a center for the Anolis work. The opportunity to create such an interdisciplinary research program attracted him in part to School of Life Sciences in ASU's College of Liberal Arts and Sciences, which Kusumi describes as a place that "breaks down the walls between disciplines. Of course, the realization of this vision depends on complex collaborations, which Kusumi jokes are growing so large that listing those not involved may be easier. Kusumi's Anolis collaborations go well beyond JARKD, STRI, TGen and ASU, and also include some of Kusumi's undergraduate mentees. Glenn Markov, a Barrett's Honors College undergraduate and member of the School of Life Sciences Undergraduate Research (SOLUR) program, has spent two years contributing to the ground work of the regeneration project. Much like the tissue-specific process of human progenitor cells, each member of the collaborative team - whether undergraduate, graduate student, or faculty - makes unique contributions to ensure the creation of a functional end product.
Mark Twain once stated "a man who carries a cat by the tail learns something he can learn in no other way." In a similar vein, Kusumi, with lizard tail in hand, may hold the most likely key to unlock the secrets of medically applicable regeneration.
Source:
Margaret Coulombe
Arizona State University
Human regeneration is mainly limited to small portions of liver tissue, bone, or muscle, yet understanding how regeneration occurs in other taxonomic groups may enable scientists to improve human regenerative abilities in the future. Kusumi is working to understand the molecular processes that enable some lizards to regenerate their tissues with fellow ASU School of Life Sciences faculty members Jeanne Wilson-Rawls, Allan Rawls, Rebecca Fisher and Dale DeNardo (collectively referred to as "JARKD" by their students). Lizards can regenerate facial bones, certain areas of the spinal cord, and, as is most commonly known, most lizards can regenerate their tail - including muscles, cartilage, and spinal cord. The regenerated tail does not contain bone, but instead is supported by a tube of hyaline cartilage - the same cartilage humans have lining many of their joints. With widespread medical problems such as arthritis and spinal cord injuries, the application of these regenerative abilities is of extreme interest to medical institutions.
"Members of my family have terrible osteoarthritis," Kusumi explains. "That means the cartilage at the joints has degenerated. These lizards can regenerate that kind of cartilage, and they have no problem doing so. How is it that we can't do this, but they can?" With the help of the Anolis model, Kusumi and the rest of the JARKD team are delving into this mystery, recently funded by a $412,606 grant from the National Institutes of Health and a $225,000 grant from the Arizona Biomedical Research Commission.
Many vertebrate and invertebrate species can regenerate tissues, but there are several kinds of regeneration. Lizards most likely use stem-cell mediated regeneration, where new cells involved in regrowth arise from tissue-specific progenitor cells. This type of regeneration is the best bet for a regenerative process compatible with the human system, Kusumi says. Now that the Anolis carolinensis genome is sequenced, rather than trying to solve the puzzle blind, the research team has a view of the bigger picture as a guide to work from.
Molecular methods have improved to the point that the JARKD team is focusing on this question at the perfect time. Kusumi mused, "the beauty is that now we know enough about development that we can actually have candidates for what cells are making this new tail - we can have guesses as to what might be right." Using this candidate approach, Wilson-Rawls and graduate student Rajani George have successfully identified and isolated lizard cells that can make new muscle. Meanwhile, the Kusumi lab is working to uncover what developmental control genes are being expressed in regenerating tails. Here, with collaborators from the Translational Genomics Research Institute (TGen), JARKD is using RNA-Seq, a next-generation technology that allows researchers to take a more unbiased approach, finding all the genes being expressed in a tissue at one point in time. When compared with embryonic development of the tail, which is being investigated by graduate student Walter Eckalbar, differences between initial tissue generation and regenerative processes can be identified. The genes involved in regeneration are likely conserved across various taxonomic classes, but the genetic switches for those genes may be turned off or down. "Once we understand the nuts and bolts of how this is happening, we can use available technologies to manipulate and change that," Kusumi explains, "then we will try to translate that to the mouse model."
A regenerating mouse tail is only one of the many images inspired by Kusumi's Anolis studies. In concert with colleagues at the Smithsonian Tropical Research Institute (STRI) in Panama and Elizabeth Hutchins, one of Kusumi's graduate students, the JARKD team is adopting an evolutionary perspective of various Anolis processes or adaptations. "Occasionally you have a very unique opportunity to look at a natural experiment where one species arrived on one island or was isolated in a region, which then led to the adaptive radiation of many species to fill a variety of niches," Kusumi says. Anolis has in fact been described by some scientists as the "Darwin's finch" of reptiles. This reference points to the number and range of ecomorphs in the Anolis genus, as species have arisen in different regions bearing highly similar behaviors and morphology (also known as convergent evolution). While anoles have been the focus of many evolutionary studies, the JARKD-STRI team is focusing on the intersection of evolution and development, where "you can look for the regulatory changes that drove a limb to be longer or muscles to be more robust."
With such a bright road ahead for both the regenerative and evolutionary undertakings, Kusumi hopes ASU will lead internationally, as a center for the Anolis work. The opportunity to create such an interdisciplinary research program attracted him in part to School of Life Sciences in ASU's College of Liberal Arts and Sciences, which Kusumi describes as a place that "breaks down the walls between disciplines. Of course, the realization of this vision depends on complex collaborations, which Kusumi jokes are growing so large that listing those not involved may be easier. Kusumi's Anolis collaborations go well beyond JARKD, STRI, TGen and ASU, and also include some of Kusumi's undergraduate mentees. Glenn Markov, a Barrett's Honors College undergraduate and member of the School of Life Sciences Undergraduate Research (SOLUR) program, has spent two years contributing to the ground work of the regeneration project. Much like the tissue-specific process of human progenitor cells, each member of the collaborative team - whether undergraduate, graduate student, or faculty - makes unique contributions to ensure the creation of a functional end product.
Mark Twain once stated "a man who carries a cat by the tail learns something he can learn in no other way." In a similar vein, Kusumi, with lizard tail in hand, may hold the most likely key to unlock the secrets of medically applicable regeneration.
Source:
Margaret Coulombe
Arizona State University
воскресенье, 31 июля 2011 г.
Follow-On Phase I Study For Novel Oral Anti-Inflammatory Drug Targeting Rheumatoid Arthritis And Type 1 Diabetes
VGX Pharmaceuticals, a biopharmaceutical company that is developing DNA vaccines for cancer and HIV and therapeutics for other diseases, announced today the results of a Phase I single ascending dose (SAD) study that demonstrated that its lead anti-inflammatory compound, VGX-1027, was generally safe and well tolerated in humans. As a result, VGX Pharmaceuticals and VGX International, a Korean affiliate that is jointly developing VGX-1027, have commenced a multiple ascending dose (MAD) study. VGX-1027 is an orally active, small molecule compound that has shown preclinical efficacy against various inflammatory diseases including rheumatoid arthritis (RA) and Type 1 diabetes (T1D).
VGX-1027 is the first of a new class of immune modulators that inhibits the production of several pro-inflammatory cytokines responsible for the damaging effects of inflammatory diseases. Preclinical studies have shown that VGX-1027 is effective in inhibiting these cytokines in cell cultures. They have also demonstrated the product's efficacy in animal models for several diseases including RA, T1D, colitis, and uveitis. Its mechanism of action includes the inhibition of NF-kB and the early transient inhibition of P38 MAP kinase signaling pathways.
Inflammatory diseases including RA, T1D, psoriasis, and colitis represent major medical problems. In the U.S. alone, over 2.7 million people suffer from rheumatoid arthritis. An additional 1 million Americans suffer from type 1 diabetes, which is fatal if untreated.
Several blockbuster therapeutic agents, primarily biologics, dominate the multi-billion dollar RA drug market. However, these agents require parenteral (e.g. such as intravenous) delivery. There are few treatment options available for T1D patients other than insulin, which requires daily injections. VGX-1027 is being investigated as an oral therapeutic.
"VGX looks forward to the results of the MAD studies for VGX-1027. Successful completion of the MAD studies would allow initiation of two Phase II studies: one for RA patients, to be conducted by VGX Pharmaceuticals, and one for T1D patients, to be conducted by VGX International," stated Dr. J. Joseph Kim, President and Chief Executive Officer.
About VGX International
More information about VGX International can be found at vgxi.
About VGX Pharmaceuticals
More information about VGX can be found at vgxp.
VGX Pharmaceuticals
VGX-1027 is the first of a new class of immune modulators that inhibits the production of several pro-inflammatory cytokines responsible for the damaging effects of inflammatory diseases. Preclinical studies have shown that VGX-1027 is effective in inhibiting these cytokines in cell cultures. They have also demonstrated the product's efficacy in animal models for several diseases including RA, T1D, colitis, and uveitis. Its mechanism of action includes the inhibition of NF-kB and the early transient inhibition of P38 MAP kinase signaling pathways.
Inflammatory diseases including RA, T1D, psoriasis, and colitis represent major medical problems. In the U.S. alone, over 2.7 million people suffer from rheumatoid arthritis. An additional 1 million Americans suffer from type 1 diabetes, which is fatal if untreated.
Several blockbuster therapeutic agents, primarily biologics, dominate the multi-billion dollar RA drug market. However, these agents require parenteral (e.g. such as intravenous) delivery. There are few treatment options available for T1D patients other than insulin, which requires daily injections. VGX-1027 is being investigated as an oral therapeutic.
"VGX looks forward to the results of the MAD studies for VGX-1027. Successful completion of the MAD studies would allow initiation of two Phase II studies: one for RA patients, to be conducted by VGX Pharmaceuticals, and one for T1D patients, to be conducted by VGX International," stated Dr. J. Joseph Kim, President and Chief Executive Officer.
About VGX International
More information about VGX International can be found at vgxi.
About VGX Pharmaceuticals
More information about VGX can be found at vgxp.
VGX Pharmaceuticals
четверг, 28 июля 2011 г.
Knee injury in women soccer players linked to early osteoarthritis
One of the fastest growing team sports in America, particularly on college campuses, is women's soccer. Of the more than 17 million players participating in organized soccer nationwide, 7 million are female. While offering an equal opportunity playing field for student athletes, soccer has one unfortunate gender bias: women are more susceptible to knee injury. One of the most common is tearing of the anterior cruciate ligament (ACL)--the ligament in the center of the knee that provides stability. In Sweden, where soccer is wildly popular and women have a shot at playing in a professional league, the risk of ACL injury is 3 to 4 times higher per game hour for young female players than for their male counterparts.
As too many soccer players know, tearing this pivotal ligament brings immediate pain and swelling, followed by a nagging fear of the knee suddenly giving-way. A recent study, published in the October 2004 issue of Arthritis & Rheumatism (interscience.wiley/journal/arthritis), provides compelling evidence of serious risk of knee osteoarthritis (OA) and potentially crippling long-term consequences of a torn ACL for young female athletes. Conducted by a team of researchers at Lund University Hospital, and supported, in part, by the Swedish Soccer Federation, this study focused on 103 female soccer players, between the ages of 26 and 40, who had each suffered an ACL injury 12 years earlier, when they were between the ages of 14 and 28.
Each woman consented to knee radiographs, as well as answered questionnaires about her knee-related quality of life. More than half of the women were assessed as having OA of the knee, accompanied by persistent pain and functional limitations. What's more, 60 percent of the players had undergone reconstructive surgery of the torn ligament soon after sustaining their injury. Using various analyses, the researchers found that surgical reconstruction had no significant effect on knee pain or disabling symptoms. The surgical techniques used today for this injury might be more effective in preventing OA, but this has not yet been proven in scientific studies.
The study's leading researcher, L. S. Lohmander, M.D., Ph.D., describes the very high prevalence of pronounced OA among these young ACL-injured women as "alarming," with serious implications for their future. "For many of these women, the OA disease process can be expected to progress over time and the need for an osteotomy or knee arthroplasty may arise well before the age of 50 years in many of these subjects," Dr. Lohmander speculates. "Although joint replacement may be an efficient treatment for knee OA, the risk of aseptic implant loosening and revision is more than 3-fold higher in the patients operated on while younger than age 65 years, than if older than 75 years."
The first long-term study of the risk and complications of OA linked to this common and serious knee injury specifically among women soccer players, its findings emphasize the need for improved efforts at prevention and treatment of this torn ligament. "Randomized, controlled trials are needed in which different surgical techniques and rehabilitation protocols are compared directly with the best nonsurgical treatment," Dr. Lohmander concludes.
Article: "High Prevalence of Knee Osteoarthritis, Pain, and Functional Limitations in Female Soccer Players Twelve Years after Anterior Cruciate Ligament Injury," L. S. Lohmander, A. Ostenberg, M. Englund, and H. Roos, Arthritis & Rheumatism, October 2004; 50:10; pp. 3145-3152.
Contact: Amy Molnar
amolnarwiley
John Wiley & Sons, Inc.
As too many soccer players know, tearing this pivotal ligament brings immediate pain and swelling, followed by a nagging fear of the knee suddenly giving-way. A recent study, published in the October 2004 issue of Arthritis & Rheumatism (interscience.wiley/journal/arthritis), provides compelling evidence of serious risk of knee osteoarthritis (OA) and potentially crippling long-term consequences of a torn ACL for young female athletes. Conducted by a team of researchers at Lund University Hospital, and supported, in part, by the Swedish Soccer Federation, this study focused on 103 female soccer players, between the ages of 26 and 40, who had each suffered an ACL injury 12 years earlier, when they were between the ages of 14 and 28.
Each woman consented to knee radiographs, as well as answered questionnaires about her knee-related quality of life. More than half of the women were assessed as having OA of the knee, accompanied by persistent pain and functional limitations. What's more, 60 percent of the players had undergone reconstructive surgery of the torn ligament soon after sustaining their injury. Using various analyses, the researchers found that surgical reconstruction had no significant effect on knee pain or disabling symptoms. The surgical techniques used today for this injury might be more effective in preventing OA, but this has not yet been proven in scientific studies.
The study's leading researcher, L. S. Lohmander, M.D., Ph.D., describes the very high prevalence of pronounced OA among these young ACL-injured women as "alarming," with serious implications for their future. "For many of these women, the OA disease process can be expected to progress over time and the need for an osteotomy or knee arthroplasty may arise well before the age of 50 years in many of these subjects," Dr. Lohmander speculates. "Although joint replacement may be an efficient treatment for knee OA, the risk of aseptic implant loosening and revision is more than 3-fold higher in the patients operated on while younger than age 65 years, than if older than 75 years."
The first long-term study of the risk and complications of OA linked to this common and serious knee injury specifically among women soccer players, its findings emphasize the need for improved efforts at prevention and treatment of this torn ligament. "Randomized, controlled trials are needed in which different surgical techniques and rehabilitation protocols are compared directly with the best nonsurgical treatment," Dr. Lohmander concludes.
Article: "High Prevalence of Knee Osteoarthritis, Pain, and Functional Limitations in Female Soccer Players Twelve Years after Anterior Cruciate Ligament Injury," L. S. Lohmander, A. Ostenberg, M. Englund, and H. Roos, Arthritis & Rheumatism, October 2004; 50:10; pp. 3145-3152.
Contact: Amy Molnar
amolnarwiley
John Wiley & Sons, Inc.
понедельник, 25 июля 2011 г.
Actemra(R), A Humanized Anti-Human IL-6 Receptor Monoclonal Antibody, Filed For Rheumatoid Arthritis In Japan
Chugai Pharmaceutical Co., Ltd. and F. Hoffmann-La Roche Ltd. announced today that the humanized anti-human IL-6 (interleukin-6) receptor monoclonal antibody, Actemra(R) [ generic name: tocilizumab (genetical recombination) ] was filed for the additional indication of rheumatoid arthritis and systemic-onset juvenile idiopathic arthritis, to the Japanese Ministry of Health, Labour and Welfare.
Rheumatoid arthritis is a systemic inflammatory disease in which the cause is unknown. The main symptoms are multiple joint inflammation and progressive joint damage. In Japan, it is estimated that approximately 330 thousand patients are undergoing treatment. Since the majority of patients are females in their 40s and 50s, the disease is causing serious psychological and social problems not only for the patients but also for their families, and a measure to counter the disease is seriously needed. Systemic-onset juvenile idiopathic arthritis is one form of rheumatoid arthritis in children, and it is estimated that there are approximately 1,700 patients in Japan*. The main symptoms are joint involvement, remittent fever and rheumatoid rash. Patients are often forced to spend a long time fighting against the disease, causing various difficulties in school life and continuing into adulthood for employment.
Actemra(R), created by Chugai in collaboration with Osaka University, utilizes genetic recombinant technology to produce monoclonal antibody from mouse anti-IL-6 receptor monoclonal antibody. It works by inhibiting IL-6 biological activity through competitively blocking the binding of IL-6 to its receptor. Chugai filed the application with the two phase III studies conducted in Japan to gather data on efficacy and safety.
Actemra(R) was launched in June 2005 in Japan as a therapy for Castleman's disease**, following approval in April, and is now in preparation for filing the additional indication of rheumatoid arthritis. Outside of Japan, phase III clinical trials in rheumatoid arthritis are going on in 41 countries worldwide including co-development between Chugai and Roche, and Roche is planning to file the application in Europe and in the US in 2007.
* Estimated by using the incidence and prevalence rate derived from a field survey on "Medical Care of Juvenile Idiopathic Arthritis and Improvement of Quality of Life, 2001," combining with the population statistics of 2003 (Ministry of Health, Labour and Welfare).
** The approved indication is "improvement of various symptoms (e.g. general malaise) and laboratory findings (e.g. increased C-reactive protein, fibrinogen, and erythrocyte sedimentation rate, decreased haemoglobin and albumin) associated with Castleman's disease."
chugai-pharm.co.jp
Rheumatoid arthritis is a systemic inflammatory disease in which the cause is unknown. The main symptoms are multiple joint inflammation and progressive joint damage. In Japan, it is estimated that approximately 330 thousand patients are undergoing treatment. Since the majority of patients are females in their 40s and 50s, the disease is causing serious psychological and social problems not only for the patients but also for their families, and a measure to counter the disease is seriously needed. Systemic-onset juvenile idiopathic arthritis is one form of rheumatoid arthritis in children, and it is estimated that there are approximately 1,700 patients in Japan*. The main symptoms are joint involvement, remittent fever and rheumatoid rash. Patients are often forced to spend a long time fighting against the disease, causing various difficulties in school life and continuing into adulthood for employment.
Actemra(R), created by Chugai in collaboration with Osaka University, utilizes genetic recombinant technology to produce monoclonal antibody from mouse anti-IL-6 receptor monoclonal antibody. It works by inhibiting IL-6 biological activity through competitively blocking the binding of IL-6 to its receptor. Chugai filed the application with the two phase III studies conducted in Japan to gather data on efficacy and safety.
Actemra(R) was launched in June 2005 in Japan as a therapy for Castleman's disease**, following approval in April, and is now in preparation for filing the additional indication of rheumatoid arthritis. Outside of Japan, phase III clinical trials in rheumatoid arthritis are going on in 41 countries worldwide including co-development between Chugai and Roche, and Roche is planning to file the application in Europe and in the US in 2007.
* Estimated by using the incidence and prevalence rate derived from a field survey on "Medical Care of Juvenile Idiopathic Arthritis and Improvement of Quality of Life, 2001," combining with the population statistics of 2003 (Ministry of Health, Labour and Welfare).
** The approved indication is "improvement of various symptoms (e.g. general malaise) and laboratory findings (e.g. increased C-reactive protein, fibrinogen, and erythrocyte sedimentation rate, decreased haemoglobin and albumin) associated with Castleman's disease."
chugai-pharm.co.jp
пятница, 22 июля 2011 г.
People With Rheumatoid Arthritis And Lupus Often Skip Their Medications
People with rheumatic diseases don't take their medication on a regular basis, and this leads to poor outcomes in their disease treatment, according to research presented this week at the American College of Rheumatology Annual Scientific Meeting in Atlanta.
Treatment adherence (consistently and correctly following the treatment plan outlined by a health care professional) is a crucial part of successfully managing rheumatic diseases such as rheumatoid arthritis and lupus. Although there are multiple ways health care professionals can monitor if their patients are taking medications as prescribed, electronic monitoring is considered one of the most accurate.
Recently researchers conducted two studies to look at adherence rates among people with RA and lupus to determine how well they follow their prescribed treatment plans. Throughout the course of the studies, researchers followed 110 participants with RA and 74 patients with lupus. The participants with RA were predominately Hispanic (67 percent) females (86 percent) with an average age of 49 years and who had suffered from RA for roughly seven years. The participants with lupus were predominately Black (49 percent) females (89 percent) with an average age of 36 years and who had suffered from lupus for roughly six years.
Both studies were two years long and recruited participants from two publicly-funded hospitals. With the permission of the participants, researchers monitored adherence using MEMS® caps, which are medicine bottle caps with a microchip that records the time and date of bottle openings. Each time a participant refilled a prescription, the researchers downloaded MEMS cap information. They calculated adherence to daily medications (such as disease modifying anti-rheumatic drugs and steroids) by determining the percentage of days with the correct dosage taken, and they calculated the adherence to weekly methotrexate by determining the percentage of doses taken within a week's time. Finally, researchers used MEMS cap data to estimate the percentage of prescribed doses taken by each participant.
"MEMS caps are the closest approach to a 'gold standard' to measure adherence, other than direct observation of the patients taking their medications which in this context and with our study duration is not feasible, and which is also thought to bias patients by increasing compliance when observed directly," explains Christian A. Waimann, MD and Maria F. Marengo, MD who are both at MD Anderson Cancer Center in Houston and who are the lead authors in the studies. Drs. Waimann and Marengo go on to explain that the MEMS caps system assumes that each opening of the bottle truly indicates the taking of the pill in the correct dose as prescribed by the physician.
The researchers noted the types of medications each participant was taking and evaluated each participant for physical pain and inflammation as well as social support and mental health at intervals of three, six, 12, 18 and 24 months.
Ninety-one percent of the participants with RA, and 81 percent of the participants with lupus completed the full course of their study. For those who didn't complete their study, researchers used what data they had to draw their conclusions.
Overall, the adherence rates in both study groups were low. The adherence rate for doses taken on schedule each day and/or week was 59 percent for participants in the RA study taking DMARDS and 64 percent for participants in the lupus study taking prednisone. Overall, only 61 percent of the participants in the RA study correctly took their medications, and the number ranged from 46 to 62 percent in the lupus study.
Additionally, researchers found that only one in five participants in both studies had an average adherence rate of 80 percent or higher. Although a small group, these participants reported better disease activity.
In the RA study, more participants were successful at taking the correct dosage of their medications than were successful at taking their medications on time each day and week (this was especially true with methotrexate). Participants in this study who had worse overall health and better mental health were found to be more adherent to their treatment plans. Finally, researchers noted that participants who lived alone, and those who were separated or were widowed showed less adherence, and those with social support might actually show more adherence.
In the lupus study, depression was associated with lower adherence, and better mental health increased the likelihood that participants would follow treatment plans. Also, researchers noted lower levels of disease activity among those participants who adhered to the correct dosages of their medication.
These results led researchers to conclude that there is poor treatment adherence among people with RA and lupus, at least in the populations studied, and that this lower adherence can affect those people's health in negative ways.
"It is important to ascertain if patients are taking their prescribed therapy as indicated before determining that a treatment is ineffective," explains Drs. Waimann and Marengo. "Physicians need to understand why patients may not take their medications as prescribed, and explain to patients the importance of taking medications as prescribed in order to reach treatment goals."
Source: American College of Rheumatology (ACR)
Treatment adherence (consistently and correctly following the treatment plan outlined by a health care professional) is a crucial part of successfully managing rheumatic diseases such as rheumatoid arthritis and lupus. Although there are multiple ways health care professionals can monitor if their patients are taking medications as prescribed, electronic monitoring is considered one of the most accurate.
Recently researchers conducted two studies to look at adherence rates among people with RA and lupus to determine how well they follow their prescribed treatment plans. Throughout the course of the studies, researchers followed 110 participants with RA and 74 patients with lupus. The participants with RA were predominately Hispanic (67 percent) females (86 percent) with an average age of 49 years and who had suffered from RA for roughly seven years. The participants with lupus were predominately Black (49 percent) females (89 percent) with an average age of 36 years and who had suffered from lupus for roughly six years.
Both studies were two years long and recruited participants from two publicly-funded hospitals. With the permission of the participants, researchers monitored adherence using MEMS® caps, which are medicine bottle caps with a microchip that records the time and date of bottle openings. Each time a participant refilled a prescription, the researchers downloaded MEMS cap information. They calculated adherence to daily medications (such as disease modifying anti-rheumatic drugs and steroids) by determining the percentage of days with the correct dosage taken, and they calculated the adherence to weekly methotrexate by determining the percentage of doses taken within a week's time. Finally, researchers used MEMS cap data to estimate the percentage of prescribed doses taken by each participant.
"MEMS caps are the closest approach to a 'gold standard' to measure adherence, other than direct observation of the patients taking their medications which in this context and with our study duration is not feasible, and which is also thought to bias patients by increasing compliance when observed directly," explains Christian A. Waimann, MD and Maria F. Marengo, MD who are both at MD Anderson Cancer Center in Houston and who are the lead authors in the studies. Drs. Waimann and Marengo go on to explain that the MEMS caps system assumes that each opening of the bottle truly indicates the taking of the pill in the correct dose as prescribed by the physician.
The researchers noted the types of medications each participant was taking and evaluated each participant for physical pain and inflammation as well as social support and mental health at intervals of three, six, 12, 18 and 24 months.
Ninety-one percent of the participants with RA, and 81 percent of the participants with lupus completed the full course of their study. For those who didn't complete their study, researchers used what data they had to draw their conclusions.
Overall, the adherence rates in both study groups were low. The adherence rate for doses taken on schedule each day and/or week was 59 percent for participants in the RA study taking DMARDS and 64 percent for participants in the lupus study taking prednisone. Overall, only 61 percent of the participants in the RA study correctly took their medications, and the number ranged from 46 to 62 percent in the lupus study.
Additionally, researchers found that only one in five participants in both studies had an average adherence rate of 80 percent or higher. Although a small group, these participants reported better disease activity.
In the RA study, more participants were successful at taking the correct dosage of their medications than were successful at taking their medications on time each day and week (this was especially true with methotrexate). Participants in this study who had worse overall health and better mental health were found to be more adherent to their treatment plans. Finally, researchers noted that participants who lived alone, and those who were separated or were widowed showed less adherence, and those with social support might actually show more adherence.
In the lupus study, depression was associated with lower adherence, and better mental health increased the likelihood that participants would follow treatment plans. Also, researchers noted lower levels of disease activity among those participants who adhered to the correct dosages of their medication.
These results led researchers to conclude that there is poor treatment adherence among people with RA and lupus, at least in the populations studied, and that this lower adherence can affect those people's health in negative ways.
"It is important to ascertain if patients are taking their prescribed therapy as indicated before determining that a treatment is ineffective," explains Drs. Waimann and Marengo. "Physicians need to understand why patients may not take their medications as prescribed, and explain to patients the importance of taking medications as prescribed in order to reach treatment goals."
Source: American College of Rheumatology (ACR)
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