Phase II clinical trial results published today in Circulation (2006;114:2374-2381) highlight the potential of a simple, once-daily dosing regimen of the novel, oral anticoagulant rivaroxaban (BAY 59-7939), a direct Factor Xa inhibitor. In this trial, rivaroxaban demonstrated that it may have similar safety and efficacy to subcutaneous enoxaparin (the current standard), for the prevention of venous thromboembolism (VTE) in patients undergoing elective total hip replacement surgery.
"These data show that we could be another step closer to the clinical reality of an oral, once-daily anticoagulant that is not associated with limitations of current standard therapies such as regular monitoring or administration by injection. The work done with rivaroxaban is important in the field of anticoagulation, and we hope to confirm these results in ongoing, extensive phase III studies," said Bengt Eriksson MD, PhD, from Sahlgrenska University Hospital in Gothenburg, Sweden, the principal investigator in this phase II trial, and one of the principal investigators in the ongoing phase III programme.
Today's publication completes the phase II programme with rivaroxaban for the prevention of VTE after major orthopaedic surgery, and contains the full data set from the once-daily dosing trial; results from twice-daily trials in hip and knee replacement surgery have already been published (Eriksson et al. J Thromb Haemost 2006;4:121-128; Turpie et al. J Thromb Haemost 2005;3:2479-86). These data taken together formed the basis of the decision to initiate the phase III programme with rivaroxaban for the prevention of VTE after orthopaedic surgery, using a once-daily dosing regimen.
The ODIXa-HIP od trial, a multi-center, randomized, international trial, evaluated 873 patients undergoing elective total hip replacement surgery for related VTE and bleeding. Study drugs were oral, once-daily rivaroxaban 5-40 mg, or the current standard, once-daily subcutaneous enoxaparin 40 mg, each continued for a further 5-9 days after surgery. The primary efficacy endpoint was the incidence of VTE (deep vein thrombosis [DVT] or pulmonary embolism [PE]), or death from any cause. The incidence of VTE was observed in 6.4-14.9% of patients receiving oral, once-daily rivaroxaban, compared with 25.2% of enoxaparin patients.
In this trial, oral rivaroxaban was shown to have similar safety to injected enoxaparin when administered once daily, as reported with twice daily rivaroxaban in earlier phase II trials. The incidence of major, post-operative bleeding was similar with the lower rivaroxaban doses and enoxaparin: major, post-operative bleeding was observed in 0.7% of patients receiving oral rivaroxaban 10 mg once daily, compared with 1.9% of patients given daily injections of enoxaparin 40 mg.
Currently, low molecular weight heparins (LMWHs; including enoxaparin) and vitamin K antagonists (VKAs, including warfarin) are used for the prevention of VTE after orthopaedic surgery. The parenteral (intravenous) administration of LMWHs limits their use, and an oral drug is more convenient for patients and physicians alike.
Clinicians currently have no alternative oral anticoagulant to VKAs, which have a slow onset of action, inter-patient variability, and several drug-drug and food-drug interactions, so their effects must be monitored carefully (with the dose increased or decreased accordingly), or the patient is at increased risk of suffering a VTE or major haemorrhage (Ansell and Berqvist. Drugs 2004 64;suppl 1:1-5).
In the United States alone, approximately 700,000 hip and knee replacements are carried out each year. If approved, the availability of a once-daily tablet could effectively protect patients against VTE, without the inherent disadvantages of current drugs.
Phase III RECORD Programme
Based on the full results published today, rivaroxaban 10 mg once daily offers the optimum combination of safety and efficacy, and was chosen as the dose for the phase III studies for the prevention of VTE after elective major orthopaedic surgery. The RECORD (REgulation of Coagulation in major Orthopaedic surgery reducing the Risk of DVT and PE) programme is currently enrolling and will evaluate over 10,000 patients. The first regulatory filing for market authorization in this indication is planned for late 2007 in Europe and 2008 in the United States.
Alexander GG Turpie, Professor of Medicine at McMaster University, Hamilton, Canada, and lead investigator of one of the RECORD studies said, "We are delighted with the progress being made in the RECORD programme, and look forward to the results next year."
About rivaroxaban:
Rivaroxaban is a first-in-class, oral, once-daily, direct Factor Xa inhibitor. It is an anticoagulant (a drug that limits blood clotting) in advanced clinical development for the effective prevention and treatment of venous and arterial thrombosis, in both the acute and chronic settings. It acts at the central point in the coagulation cascade, to regulate thrombin generation, which leads to clot formation.
Present published results show that rivaroxaban offers predictable anticoagulation across a wide range of parameters, which strongly suggests that coagulation monitoring will not be required. In addition, data also show that rivaroxaban does not interact with a wide variety of drugs that are commonly given concomitantly with an anticoagulant.
Rivaroxaban is being jointly developed by Bayer HealthCare and Ortho-McNeil Pharmaceuticals Inc., Johnson & Johnson Pharmaceutical Research and Development, affiliates of Johnson & Johnson.
Bayer HealthCare
Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the health care and medical products industry based in Leverkusen/Germany. In 2005, the Bayer HealthCare subgroup generated sales amounting to some 9.4 billion Euro. Bayer HealthCare employed 33,800 people worldwide in 2005.
The company combines the global activities of the divisions Animal Health, Consumer Care, Diabetes Care, Diagnostics and Pharmaceuticals. Since January 1, 2006, the new Pharmaceutical Division consists of the former Biological Products and Pharmaceutical Division and now comprises three business units: Hematology/Cardiology, Oncology and Primary Care.
Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and treating diseases.
About Ortho-McNeil, Inc.
Ortho-McNeil, Inc. provides innovative prescription medicines for pain, acid reflux disease and infectious diseases, and serves primary care providers, hospitals and other healthcare facilities. PriCara, a Unit of Ortho-McNeil, Inc., is fully dedicated to the needs of primary care healthcare professionals and their patients, and is the only major healthcare organization in the U.S. singularly focused on primary care. Headquarters are in Raritan, New Jersey.
Forward-Looking Statements
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including our Form 20-F).The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
View drug information on Warfarin Sodium tablets.
суббота, 25 июня 2011 г.
среда, 22 июня 2011 г.
Premature Vascular And Bone Changes Occur In COPD Patients
Researchers in the United Kingdom have found that patients with COPD, or chronic obstructive pulmonary disease, have greater arterial stiffness. The researchers also found that those COPD patients with osteoporosis, a common complication of the respiratory disease, had even greater arterial stiffness. These premature signs of aging may explain why COPD patients are at greater risk for cardiovascular disease.
Their research results appear in the second issue for June 2007 of the American Journal of Respiratory and Critical Care Medicine, published by the American Thoracic Society.
Dennis J. Shale, M.D., of the Department of Respiratory Medicine at Cardiff University in the United Kingdom, and eight associates studied 75 clinically stable COPD patients who had various levels of airway obstruction, and 42 smoker or ex-smoker control subjects who did not have cardiovascular disease or COPD.
All participants in the study underwent spirometry to determine lung function, had their aortic pulse wave velocity measured along with another indirect measurement of arterial stiffness, took bone mineral density tests of their spine and hips, and had their blood sampled for inflammatory mediators.
COPD, the fourth leading cause of death in the United States and the world, involves persistent obstruction of the airways caused by emphysema or chronic bronchitis. In most instances, both conditions result from years of smoking cigarettes.
Though the exact link between COPD and arterial stiffness was not identified by the researchers, they did find elevated levels of inflammation markers in those with COPD. Other researchers have demonstrated that inflammatory processes are involved in arteriosclerosis, the cardiovascular disease commonly known as "hardening of the arteries."
There is also evidence that inflammation plays a role in osteoporosis. In this study, patients with osteoporosis had the greatest arterial stiffness.
"Increased arterial stiffness was present in patients with COPD over a wide range of severity of airway obstruction and was greatest in those with osteoporosis," said Dr. Shale. "Our findings indicate vascular changes predictive of cardiovascular disease occur and remain undetected in mild or early lung disease and may underlie the excess cardiovascular risk in COPD."
The researchers noted that age was an important factor influencing arterial stiffness, a problem that reflects the increasing rigidity of the aortic artery. The average age of the study cohort was 63.
"The increased arterial stiffness in patients within each decade is similar to changes seen in type I diabetes mellitus and suggest that age-related vascular changes occur prematurely in COPD, as compared with disease-free individuals," said Dr. Shale.
"However, unlike diabetes mellitus, the risk of premature excess cardiovascular disease in COPD is not appreciated."
At the beginning of the study, none of the participants had a history of heart disease or possessed cardiovascular symptoms. Of the 75 COPD patients studied, 18 had osteoporosis, while among the controls, only two individuals suffered from abnormal loss of bony tissue. Also, those who had osteoporosis of the hip had a greater aortic pulse wave velocity than those without the hip problem.
In an editorial on the study in the same issue of the journal, Claus Vogelmeier, M.D., and Robert Bals, M.D., of Philipps-University, Marburg in Germany, said that the study provides "important new information" on the relationship of cardiovascular disease and COPD.
They noted that aortic pulse wave velocity-considered the most clinically relevant measure of arterial stiffness-has been shown to predict cardiovascular outcome in various populations. The authors also highlighted the study's correlation of pulse wave velocity and COPD severity as important.
"The more severe the flow limitation, the higher the pulse wave velocity values," wrote Drs. Vogelmeier and Bals. "Thus, COPD may induce arterial stiffness, which in turn may promote vascular remodeling, thickening of arterial walls and plaque formation. The process may start in the early stages of COPD and worsen with the decline of lung function."
The editorialists also commented on osteoporosis, which was the second focus of the study: "The authors found that bone mineral density was lower in patients with COPD than in control subjects. Among the patients with COPD, 32 percent had osteoporosis and this was not restricted to those with severe COPD."
Although the editorialists termed the relationship between COPD and osteoporosis in the study was not "novel," they noted that those patients with osteoporosis also had the greatest arterial stiffness values-a new finding.
They concluded that future research is necessary to uncover further relationships between this study's findings and accelerated aging processes in COPD, which might then be avoided.
This news brief is based on an article published in the American Thoracic Society's peer-reviewed journal, the American Journal of Respiratory and Critical Care Medicine.
Founded in 1905, the American Thoracic Society is the world's leading medical association dedicated to advancing pulmonary, critical care and sleep medicine. The Society has more than 18,000 members who prevent and fight respiratory disease around the globe, through research, education, patient care and advocacy.
American Thoracic Society
61 Broadway, 4th Floor
New York, NY 10006-2755
thoracic
Their research results appear in the second issue for June 2007 of the American Journal of Respiratory and Critical Care Medicine, published by the American Thoracic Society.
Dennis J. Shale, M.D., of the Department of Respiratory Medicine at Cardiff University in the United Kingdom, and eight associates studied 75 clinically stable COPD patients who had various levels of airway obstruction, and 42 smoker or ex-smoker control subjects who did not have cardiovascular disease or COPD.
All participants in the study underwent spirometry to determine lung function, had their aortic pulse wave velocity measured along with another indirect measurement of arterial stiffness, took bone mineral density tests of their spine and hips, and had their blood sampled for inflammatory mediators.
COPD, the fourth leading cause of death in the United States and the world, involves persistent obstruction of the airways caused by emphysema or chronic bronchitis. In most instances, both conditions result from years of smoking cigarettes.
Though the exact link between COPD and arterial stiffness was not identified by the researchers, they did find elevated levels of inflammation markers in those with COPD. Other researchers have demonstrated that inflammatory processes are involved in arteriosclerosis, the cardiovascular disease commonly known as "hardening of the arteries."
There is also evidence that inflammation plays a role in osteoporosis. In this study, patients with osteoporosis had the greatest arterial stiffness.
"Increased arterial stiffness was present in patients with COPD over a wide range of severity of airway obstruction and was greatest in those with osteoporosis," said Dr. Shale. "Our findings indicate vascular changes predictive of cardiovascular disease occur and remain undetected in mild or early lung disease and may underlie the excess cardiovascular risk in COPD."
The researchers noted that age was an important factor influencing arterial stiffness, a problem that reflects the increasing rigidity of the aortic artery. The average age of the study cohort was 63.
"The increased arterial stiffness in patients within each decade is similar to changes seen in type I diabetes mellitus and suggest that age-related vascular changes occur prematurely in COPD, as compared with disease-free individuals," said Dr. Shale.
"However, unlike diabetes mellitus, the risk of premature excess cardiovascular disease in COPD is not appreciated."
At the beginning of the study, none of the participants had a history of heart disease or possessed cardiovascular symptoms. Of the 75 COPD patients studied, 18 had osteoporosis, while among the controls, only two individuals suffered from abnormal loss of bony tissue. Also, those who had osteoporosis of the hip had a greater aortic pulse wave velocity than those without the hip problem.
In an editorial on the study in the same issue of the journal, Claus Vogelmeier, M.D., and Robert Bals, M.D., of Philipps-University, Marburg in Germany, said that the study provides "important new information" on the relationship of cardiovascular disease and COPD.
They noted that aortic pulse wave velocity-considered the most clinically relevant measure of arterial stiffness-has been shown to predict cardiovascular outcome in various populations. The authors also highlighted the study's correlation of pulse wave velocity and COPD severity as important.
"The more severe the flow limitation, the higher the pulse wave velocity values," wrote Drs. Vogelmeier and Bals. "Thus, COPD may induce arterial stiffness, which in turn may promote vascular remodeling, thickening of arterial walls and plaque formation. The process may start in the early stages of COPD and worsen with the decline of lung function."
The editorialists also commented on osteoporosis, which was the second focus of the study: "The authors found that bone mineral density was lower in patients with COPD than in control subjects. Among the patients with COPD, 32 percent had osteoporosis and this was not restricted to those with severe COPD."
Although the editorialists termed the relationship between COPD and osteoporosis in the study was not "novel," they noted that those patients with osteoporosis also had the greatest arterial stiffness values-a new finding.
They concluded that future research is necessary to uncover further relationships between this study's findings and accelerated aging processes in COPD, which might then be avoided.
This news brief is based on an article published in the American Thoracic Society's peer-reviewed journal, the American Journal of Respiratory and Critical Care Medicine.
Founded in 1905, the American Thoracic Society is the world's leading medical association dedicated to advancing pulmonary, critical care and sleep medicine. The Society has more than 18,000 members who prevent and fight respiratory disease around the globe, through research, education, patient care and advocacy.
American Thoracic Society
61 Broadway, 4th Floor
New York, NY 10006-2755
thoracic
воскресенье, 19 июня 2011 г.
Repetitive Chopstick Use Can Cause Osteoarthritis of the Hand
Never quite mastered the art of using chopsticks? Don't fret; new research suggests that you may actually be doing your hands a favor by sticking with a fork.
The study shows people who use chopsticks on a daily basis are more likely to develop hand osteoarthritis, the most common form of arthritis that is often due to excessive use of joints.
Researchers say using chopsticks places stress on particular joints in the first, second, and third fingers, which may increase the risk of osteoarthritis in these joints.
The results of the study were presented this week at the American College of Rheumatology Annual Scientific Meeting in Orlando, Fla.
Chopstick Use Stresses Hands
Researchers studied more than 2,500 Chinese adults with an average age of 60 and asked them whether they were right-handed or left-handed and which hand they preferred while eating with chopsticks or performing other grip-related activities.
The participants also underwent hand X-rays to look for joint damage due to osteoarthritis.
The study showed that osteoarthritis was more common in the joints involved in chopstick use compared with non-chopstick joints.
In addition, participants who were ambidextrous (had no hand preference in general) but had a preferred hand for chopstick use were more likely to have osteoarthritis in that preferred hand. This suggests that the osteoarthritis was due to chopstick use rather than other activities involving the hands.
The study also showed that 26% of the participants had evidence of osteoarthritis in their thumb, and chopstick use accounted for 20% of the risk of developing this in men and 37% in women.
'While the increase in risk associated with chopstick use is small, this accounts for a large proportion of the osteoarthritis in these joint groups,' says researcher David Hunter, MD, assistant professor at Boston University School of Medicine, in a news release.
Researchers say these findings are in line with previous studies that have shown occupational groups exposed to repetitive use of small hand joints also have higher than normal rates of hand osteoarthritis in those joints.
The study shows people who use chopsticks on a daily basis are more likely to develop hand osteoarthritis, the most common form of arthritis that is often due to excessive use of joints.
Researchers say using chopsticks places stress on particular joints in the first, second, and third fingers, which may increase the risk of osteoarthritis in these joints.
The results of the study were presented this week at the American College of Rheumatology Annual Scientific Meeting in Orlando, Fla.
Chopstick Use Stresses Hands
Researchers studied more than 2,500 Chinese adults with an average age of 60 and asked them whether they were right-handed or left-handed and which hand they preferred while eating with chopsticks or performing other grip-related activities.
The participants also underwent hand X-rays to look for joint damage due to osteoarthritis.
The study showed that osteoarthritis was more common in the joints involved in chopstick use compared with non-chopstick joints.
In addition, participants who were ambidextrous (had no hand preference in general) but had a preferred hand for chopstick use were more likely to have osteoarthritis in that preferred hand. This suggests that the osteoarthritis was due to chopstick use rather than other activities involving the hands.
The study also showed that 26% of the participants had evidence of osteoarthritis in their thumb, and chopstick use accounted for 20% of the risk of developing this in men and 37% in women.
'While the increase in risk associated with chopstick use is small, this accounts for a large proportion of the osteoarthritis in these joint groups,' says researcher David Hunter, MD, assistant professor at Boston University School of Medicine, in a news release.
Researchers say these findings are in line with previous studies that have shown occupational groups exposed to repetitive use of small hand joints also have higher than normal rates of hand osteoarthritis in those joints.
четверг, 16 июня 2011 г.
Mobilize With Care Following Ankle Surgery
People recover faster after surgery for ankle fracture if they are given a cast or splint that can be removed to let them exercise the ankle, than if their foot is placed in an immobilising plaster cast. If the fracture is stable, then encouraging them to walk soon after surgery is also beneficial. However, increased activity does increase the chance of experiencing problems with the surgical wound. These conclusions are published in a systematic review included in the latest update of The Cochrane Library.
Ankle fracture is one of the most common fractures of the lower limb, especially in young men and older women. In about half of the cases, the broken bone requires surgery to realign the bones, and then the lower leg and foot are placed in a cast to immobilise and protect the area.
The problem with immobilisation is that it can lead to pain, stiffness, weakness and swelling in the ankle. A team of Cochrane Researchers therefore looked to see whether there was evidence that using removable casts or splints can improve outcome.
The researchers found only limited evidence, but current research indicated that removable casts or splints which allow the ankle to be exercised soon after surgery reduced pain and increased mobility when compared to using a traditional plaster cast. But early exercise on the ankle also led to increased (albeit mainly minor) adverse events, such as problems with the surgical wound and changes in skin sensation.
"Getting a patient to exercise soon after surgery has significant benefits, but the increased risks to the wound show that you need to make sure that a person can do this safely before supplying them with a removable cast or splint instead of a standard cast," says Christine Lin, who works at the Musculoskeletal Division of The George Institute for International Health, Australia.
News from The Cochrane Library
Source: Jennifer Beal
Wiley-Blackwell
Ankle fracture is one of the most common fractures of the lower limb, especially in young men and older women. In about half of the cases, the broken bone requires surgery to realign the bones, and then the lower leg and foot are placed in a cast to immobilise and protect the area.
The problem with immobilisation is that it can lead to pain, stiffness, weakness and swelling in the ankle. A team of Cochrane Researchers therefore looked to see whether there was evidence that using removable casts or splints can improve outcome.
The researchers found only limited evidence, but current research indicated that removable casts or splints which allow the ankle to be exercised soon after surgery reduced pain and increased mobility when compared to using a traditional plaster cast. But early exercise on the ankle also led to increased (albeit mainly minor) adverse events, such as problems with the surgical wound and changes in skin sensation.
"Getting a patient to exercise soon after surgery has significant benefits, but the increased risks to the wound show that you need to make sure that a person can do this safely before supplying them with a removable cast or splint instead of a standard cast," says Christine Lin, who works at the Musculoskeletal Division of The George Institute for International Health, Australia.
News from The Cochrane Library
Source: Jennifer Beal
Wiley-Blackwell
понедельник, 13 июня 2011 г.
This Study May Prevent Broken Bones
The best way to prevent a fracture is to stop bones from reaching the point where they are prone to breaking, but understanding the process of how bones form and mature has been challenging. Now researchers at the University of Houston department of health and human performance have created a process that grows real human bone in tissue culture, which can be used to investigate how bones form and grow.
"We have manufactured a structure that has no synthetic components," said Mark Clarke, associate professor and principal investigator. "It's all made by the two cell types bones start with inside the body. What you end up with is a piece of material that is identical to newly-formed, human, trabecular bone, including its mineral components, its histology and its growth factor content."
Being in a microgravity environment causes astronauts' bodies to lose more bone mineral than they can replace, which makes them vulnerable to fractures and breaks. Even when they return to Earth, the bone loss continues as their bodies slowly begin the process of replacing the bone mineral content.
The NASA-funded study, which included Clarke's collaborators at NASA-Johnson Space Center, Dr. Neal Pellis and Dr. Alamelu Sundaresan, used human osteoblasts and osteoclasts, the two major cell types involved in the formation of and breaking down of bone. The 3-dimensional bone constructs allowed for ideal conditions to investigate how bone forms and, more importantly, how bone is lost in environments such as space flight and conditions present in post-menopausal women and spinal cord patients.
Clarke has worked with NASA on other bone loss studies. He served as a principal investigator in a NASA study of micro-fabricated skin patches that collect sweat for analysis of biomarkers of bone loss, like calcium.
His research on bone formation also is proving to be market-ready, as a newly formed start-up company, OsteoSphere Inc., examines ways the breakthrough research can be used in a clinical setting for applications such as spinal fusions, facial reconstructions following bomb blasts or the re-growing of an individual bone outside of the patient,.
"UH has now licensed the technology to OsteoSphere Inc. which is looking at ways to commercialize the technology in a clinical setting, including culturing an individual's own bone for subsequent transplantation back into the patient, developing other products for use in orthopedic reconstruction or using the technology as a screening tool for development of pharmaceuticals for combating bone loss or stimulating bone regeneration," Clarke said.
Source: Marisa Ramirez
University of Houston
"We have manufactured a structure that has no synthetic components," said Mark Clarke, associate professor and principal investigator. "It's all made by the two cell types bones start with inside the body. What you end up with is a piece of material that is identical to newly-formed, human, trabecular bone, including its mineral components, its histology and its growth factor content."
Being in a microgravity environment causes astronauts' bodies to lose more bone mineral than they can replace, which makes them vulnerable to fractures and breaks. Even when they return to Earth, the bone loss continues as their bodies slowly begin the process of replacing the bone mineral content.
The NASA-funded study, which included Clarke's collaborators at NASA-Johnson Space Center, Dr. Neal Pellis and Dr. Alamelu Sundaresan, used human osteoblasts and osteoclasts, the two major cell types involved in the formation of and breaking down of bone. The 3-dimensional bone constructs allowed for ideal conditions to investigate how bone forms and, more importantly, how bone is lost in environments such as space flight and conditions present in post-menopausal women and spinal cord patients.
Clarke has worked with NASA on other bone loss studies. He served as a principal investigator in a NASA study of micro-fabricated skin patches that collect sweat for analysis of biomarkers of bone loss, like calcium.
His research on bone formation also is proving to be market-ready, as a newly formed start-up company, OsteoSphere Inc., examines ways the breakthrough research can be used in a clinical setting for applications such as spinal fusions, facial reconstructions following bomb blasts or the re-growing of an individual bone outside of the patient,.
"UH has now licensed the technology to OsteoSphere Inc. which is looking at ways to commercialize the technology in a clinical setting, including culturing an individual's own bone for subsequent transplantation back into the patient, developing other products for use in orthopedic reconstruction or using the technology as a screening tool for development of pharmaceuticals for combating bone loss or stimulating bone regeneration," Clarke said.
Source: Marisa Ramirez
University of Houston
пятница, 10 июня 2011 г.
Surgery Is More Effective Than Other Treatments For Common Back Problem, Study Finds
When it comes to low back pain, physicians generally advise exhausting nonsurgical options before resorting to surgery. But a new study shows that for degenerative spondylolisthesis with spinal stenosis, surgery provides significantly better results than nonsurgical alternatives. The study, published in a recent issue of the New England Journal of Medicine, is the second in a series reporting findings of the Spine Patients Outcomes Research Trial (SPORT), a five-year, multicenter study supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), a part of the National Institutes of Health.
Degenerative spondylolisthesis is a condition in which breakdown of the cartilage between the vertebrae of the spine causes one vertebra to slip over the one below. This can result in narrowing of the spinal column (spinal stenosis), which can put pressure on the nerves, resulting in pain in the buttocks or legs with walking or standing. The condition generally occurs after age 50 and it affects six times as many women as men.
The management of degenerative spondylolisthesis with spinal stenosis is controversial, says James N. Weinstein, D.O., M.Sc., lead author and chairman of the Departments of Orthopaedics at Dartmouth-Hitchcock Medical Center and Dartmouth Medical School. Surgery is widely used, but its effectiveness in comparison with nonsurgical treatment had not been demonstrated in controlled clinical trials. The purpose of this arm of the SPORT trial was to make that comparison.
SPORT followed 601 patients diagnosed with degenerative spondylolisthesis and symptomatic spinal stenosis. Of those, 372 received a surgery called decompressive laminectomy, which involved removing bone and soft tissue to relieve pressure on the nerves. The remaining 235 pursued nonoperative treatments such as physical therapy, steroid injections and analgesic medications. Two years after enrollment in the trial, patients in the nonoperative groups reported modest improvement in their condition; however, patients who had the surgery reported significantly reduced pain and improved function. Furthermore, for the surgery group, relief from symptoms came quickly; some reported significant improvement as early as six weeks after the procedure.
"The SPORT study was undertaken with one purpose in mind: to give physicians and patients solid information that would allow them to make informed choices when faced with a decision of how to treat their back condition," says Dr. Weinstein. "As a surgeon, it's very important to me that I have evidence that I can share with my patients as they are trying to decide how to proceed with treatment. Up until now, we suspected surgery produced better results, but we had little objective data to support that. With the results of this study, we can now discuss much more fully the surgical and nonsurgical options available to our patients so that they can make an informed choice."
The study initially intended to randomize patients into either a surgical or nonsurgical group and then observe and compare the results of the two groups. Unfortunately, a comparison of the two groups wasn't as easy as hoped. The researchers found that 40 percent of patients crossed over from the group into which they were randomized. That is, members of the nonoperative group chose to have surgery and members of the surgical group decided to forgo surgery for nonsurgical treatments. For that reason, the researchers compared groups based on the treatment they actually received instead of the treatment group to which they were assigned. Because the scientists were also studying similar patients who wanted to select which treatment they would receive (instead of being randomly assigned to a surgical or nonsurgical option), they were able to pool results from both studies, essentially creating a more powerful osbservational study at the expense of information gained from the statistically rigorous study design originally planned.
Patient crossover was also an issue in the first arm of the SPORT trial, which showed that patients who underwent surgery for another common back problem - herniated discs - experienced slightly more improvement than those who opted for nonsurgical treatments. Results of that trial were published in the Journal of the American Medical Association last November.
Results from the third major SPORT study, on the effectiveness of surgery vs. nonsurgical options for spinal stenosis without spondylolisthesis, are expected to be released later this year.
NIAMS Director Stephen I. Katz, M.D., Ph.D., applauds the SPORT trial, saying its findings are beneficial for people with these common back problems. "While it is generally not a good idea to rush into back surgery, the SPORT trial shows there are conditions for which surgery clearly is the most effective treatment choice. These findings will help doctors better counsel their patients about treatment options."
Additional support was provided for this research by the NIH Office of Research on Women's Health and the National Institute of Occupational Safety and Health (NIOSH).
The mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), a part of the Department of Health and Human Services' National Institutes of Health, is to support research into the causes, treatment and prevention of arthritis and musculoskeletal and skin diseases; the training of basic and clinical scientists to carry out this research; and the dissemination of information on research progress in these diseases. For more information about NIAMS, visit the NIAMS Web site at niams.nih/.
The National Institutes of Health (NIH) - The Nation's Medical Research Agency - includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit wnih/.
Reference: Weinstein JN, et al. Surgical versus nonsurgical treatment for lumbar degenerative spondylolisthesis. NEJM 2007;356(22):2257-2270.
Contact: Ray Fleming
NIH/National Institute of Arthritis and Musculoskeletal and Skin Diseases
Degenerative spondylolisthesis is a condition in which breakdown of the cartilage between the vertebrae of the spine causes one vertebra to slip over the one below. This can result in narrowing of the spinal column (spinal stenosis), which can put pressure on the nerves, resulting in pain in the buttocks or legs with walking or standing. The condition generally occurs after age 50 and it affects six times as many women as men.
The management of degenerative spondylolisthesis with spinal stenosis is controversial, says James N. Weinstein, D.O., M.Sc., lead author and chairman of the Departments of Orthopaedics at Dartmouth-Hitchcock Medical Center and Dartmouth Medical School. Surgery is widely used, but its effectiveness in comparison with nonsurgical treatment had not been demonstrated in controlled clinical trials. The purpose of this arm of the SPORT trial was to make that comparison.
SPORT followed 601 patients diagnosed with degenerative spondylolisthesis and symptomatic spinal stenosis. Of those, 372 received a surgery called decompressive laminectomy, which involved removing bone and soft tissue to relieve pressure on the nerves. The remaining 235 pursued nonoperative treatments such as physical therapy, steroid injections and analgesic medications. Two years after enrollment in the trial, patients in the nonoperative groups reported modest improvement in their condition; however, patients who had the surgery reported significantly reduced pain and improved function. Furthermore, for the surgery group, relief from symptoms came quickly; some reported significant improvement as early as six weeks after the procedure.
"The SPORT study was undertaken with one purpose in mind: to give physicians and patients solid information that would allow them to make informed choices when faced with a decision of how to treat their back condition," says Dr. Weinstein. "As a surgeon, it's very important to me that I have evidence that I can share with my patients as they are trying to decide how to proceed with treatment. Up until now, we suspected surgery produced better results, but we had little objective data to support that. With the results of this study, we can now discuss much more fully the surgical and nonsurgical options available to our patients so that they can make an informed choice."
The study initially intended to randomize patients into either a surgical or nonsurgical group and then observe and compare the results of the two groups. Unfortunately, a comparison of the two groups wasn't as easy as hoped. The researchers found that 40 percent of patients crossed over from the group into which they were randomized. That is, members of the nonoperative group chose to have surgery and members of the surgical group decided to forgo surgery for nonsurgical treatments. For that reason, the researchers compared groups based on the treatment they actually received instead of the treatment group to which they were assigned. Because the scientists were also studying similar patients who wanted to select which treatment they would receive (instead of being randomly assigned to a surgical or nonsurgical option), they were able to pool results from both studies, essentially creating a more powerful osbservational study at the expense of information gained from the statistically rigorous study design originally planned.
Patient crossover was also an issue in the first arm of the SPORT trial, which showed that patients who underwent surgery for another common back problem - herniated discs - experienced slightly more improvement than those who opted for nonsurgical treatments. Results of that trial were published in the Journal of the American Medical Association last November.
Results from the third major SPORT study, on the effectiveness of surgery vs. nonsurgical options for spinal stenosis without spondylolisthesis, are expected to be released later this year.
NIAMS Director Stephen I. Katz, M.D., Ph.D., applauds the SPORT trial, saying its findings are beneficial for people with these common back problems. "While it is generally not a good idea to rush into back surgery, the SPORT trial shows there are conditions for which surgery clearly is the most effective treatment choice. These findings will help doctors better counsel their patients about treatment options."
Additional support was provided for this research by the NIH Office of Research on Women's Health and the National Institute of Occupational Safety and Health (NIOSH).
The mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), a part of the Department of Health and Human Services' National Institutes of Health, is to support research into the causes, treatment and prevention of arthritis and musculoskeletal and skin diseases; the training of basic and clinical scientists to carry out this research; and the dissemination of information on research progress in these diseases. For more information about NIAMS, visit the NIAMS Web site at niams.nih/.
The National Institutes of Health (NIH) - The Nation's Medical Research Agency - includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit wnih/.
Reference: Weinstein JN, et al. Surgical versus nonsurgical treatment for lumbar degenerative spondylolisthesis. NEJM 2007;356(22):2257-2270.
Contact: Ray Fleming
NIH/National Institute of Arthritis and Musculoskeletal and Skin Diseases
вторник, 7 июня 2011 г.
Total Knee Replacement Appears Cost-Effective In Older Adults
Total knee replacement (arthroplasty) appears to be a cost-effective procedure for older adults with advanced osteoarthritis, according to a report in the June 22 issue of Archives of Internal Medicine, one of the JAMA/Archives journals. The procedure appears to be cost-effective across all patient risk groups, and appeared more costly and less effective in low-volume centers than in high-volume centers.
Approximately 12 percent of adults older than 60 have symptoms of knee osteoarthritis, and their direct medical costs are estimated to range from $1,000 to $4,100 per person per year, according to background information in the article. "Total knee arthroplasty is a frequently performed and effective procedure that relieves pain and improves functional status in patients with end-stage knee osteoarthritis," the authors write. "Almost 500,000 total knee arthroplasties were performed in the United States in 2005 at a cost exceeding $11 billion. Projections indicate dramatic growth in the use of total knee arthroplasty over the next two decades."
Elena Losina, Ph.D., of Brigham and Women's Hospital and the Boston University School of Public Health, and colleagues developed a computer simulation model and populated it with Medicare claims data and cost and outcomes data from national and multinational sources. They then projected lifetime costs and quality-adjusted life expectancy-or the number of years remaining of good health-for patients at different levels of risk and receiving total knee arthroplasty at high-volume or low-volume facilities.
Overall, having a total knee arthroplasty increased quality-adjusted life expectancy of the Medicare population (average age 74) from 6.822 to 7.957 quality-adjusted life years (years of life in perfect health). Total costs increased from $37,100 among individuals not receiving total knee arthroplasty to $57,900 per person undergoing total knee arthroplasty, resulting in a cost-effectiveness ratio of $18,300 per quality-adjusted life year. Therefore, total knee arthroplasty is a highly cost-effective procedure for the management of end-stage knee osteoarthritis compared with non-surgical treatments and is within the range of accepted cost-effectiveness for other musculoskeletal procedures, the authors note.
"This result is robust across a broad range of assumptions regarding both patient risk and hospital volume," they write. "For patients who choose to undergo total knee arthroplasty, hospital volume plays an important role: regardless of patient risk level, higher-volume centers consistently deliver better outcomes. But the additional survival benefits associated with high-volume centers provide limited cost-effectiveness benefits for high-risk patients deliberating between medium- and high-volume centers." Even procedures performed in low-volume centers were more cost-effective than not having total knee arthroplasty, regardless of the patient's risk of complications.
"Clinicians, patients and policy makers should consider the relative cost-effectiveness of total knee arthroplasty in making decisions about who should undergo total knee arthroplasty, where and when," the authors conclude.
Arch Intern Med. 2009;169[12]:1113-1121
Source
Archives of Internal Medicine
Approximately 12 percent of adults older than 60 have symptoms of knee osteoarthritis, and their direct medical costs are estimated to range from $1,000 to $4,100 per person per year, according to background information in the article. "Total knee arthroplasty is a frequently performed and effective procedure that relieves pain and improves functional status in patients with end-stage knee osteoarthritis," the authors write. "Almost 500,000 total knee arthroplasties were performed in the United States in 2005 at a cost exceeding $11 billion. Projections indicate dramatic growth in the use of total knee arthroplasty over the next two decades."
Elena Losina, Ph.D., of Brigham and Women's Hospital and the Boston University School of Public Health, and colleagues developed a computer simulation model and populated it with Medicare claims data and cost and outcomes data from national and multinational sources. They then projected lifetime costs and quality-adjusted life expectancy-or the number of years remaining of good health-for patients at different levels of risk and receiving total knee arthroplasty at high-volume or low-volume facilities.
Overall, having a total knee arthroplasty increased quality-adjusted life expectancy of the Medicare population (average age 74) from 6.822 to 7.957 quality-adjusted life years (years of life in perfect health). Total costs increased from $37,100 among individuals not receiving total knee arthroplasty to $57,900 per person undergoing total knee arthroplasty, resulting in a cost-effectiveness ratio of $18,300 per quality-adjusted life year. Therefore, total knee arthroplasty is a highly cost-effective procedure for the management of end-stage knee osteoarthritis compared with non-surgical treatments and is within the range of accepted cost-effectiveness for other musculoskeletal procedures, the authors note.
"This result is robust across a broad range of assumptions regarding both patient risk and hospital volume," they write. "For patients who choose to undergo total knee arthroplasty, hospital volume plays an important role: regardless of patient risk level, higher-volume centers consistently deliver better outcomes. But the additional survival benefits associated with high-volume centers provide limited cost-effectiveness benefits for high-risk patients deliberating between medium- and high-volume centers." Even procedures performed in low-volume centers were more cost-effective than not having total knee arthroplasty, regardless of the patient's risk of complications.
"Clinicians, patients and policy makers should consider the relative cost-effectiveness of total knee arthroplasty in making decisions about who should undergo total knee arthroplasty, where and when," the authors conclude.
Arch Intern Med. 2009;169[12]:1113-1121
Source
Archives of Internal Medicine
суббота, 4 июня 2011 г.
More Than Half Of All ACL Reconstructions Could Be Avoided
Anterior cruciate ligament (ACL) injuries are common injuries to the knee, primarily affecting young people who practise sport and often treated with surgical reconstruction. A research group from Lund University has now shown that 60 per cent of these operations could be avoided, without negatively affecting treatment outcomes.
The research group's study is known as the KANON study and started in 2001. This week the group is publishing its results in the New England Journal of Medicine.
"In our study, patients with acute ACL injuries were randomly divided into two groups for treatment with rehabilitation plus early ACL reconstruction or rehabilitation alone with the possibility of a later operation if this was deemed necessary. After two years only 40 per cent of the latter group needed to have an ACL reconstruction.
"Despite the fact that many of the patients were active sportsmen and women, we found no difference between the treatment groups in terms of knee function, activity level or well-being two years after the injury. Neither did we find any difference in these respects when we compared those who were treated with rehabilitation alone with those who had an early operation", says Richard Frobell, researcher at Lund University, SkГҐne University Hospital and Helsingborg Hospital.
A total of 121 patients took part in the study, which was carried out in collaboration with Helsingborg Hospital and SkГҐne University Hospital in Lund. The patients were aged between 18 and 35 and had an acute ACL injury in a previously healthy knee. Professional athletes and those who did not regularly practise sport were excluded from the study. All patients underwent extensive rehabilitation, led by experienced physiotherapists.
Sixty-two patients were selected at random to also undergo surgical reconstruction of the injured ligament within four to six weeks of the injury, and 59 patients were selected at random to initially undergo treatment with rehabilitation alone. All the operations were carried out in accordance with well established methods and by experienced surgeons. The patients were examined on several occasions over two years and gave their own opinions of the status of the injured knee.
"There are almost 10 000 scientific publications addressing the ACL and 50 per cent of these are about surgical treatment. However, none of these studies have shown that surgical reconstruction produces better results than rehabilitation alone. Despite this, we perform 3 000 cruciate ligament reconstructions a year in Sweden", says Stefan Lohmander, professor and consultant at Lund University and SkГҐne University Hospital. "In the USA there are 200 000 operations of this type, at a cost of USD 3 billion!"
The research group's results have strengthened their conviction that there is no evidence to support the recommendation of ACL reconstruction as a first method of treatment.
Rehabilitation with experienced physiotherapists produces the same results as operation for more than half of the individuals in this patient group and only four out of ten need to be exposed to the risks involved in an operation.
The patients in the study will continue to be examined in order to find out whether the results are the same in the longer term and to see if there is any difference between treatments in terms of the risk of developing osteoarthritis in the knee.
Source: Lund University
The research group's study is known as the KANON study and started in 2001. This week the group is publishing its results in the New England Journal of Medicine.
"In our study, patients with acute ACL injuries were randomly divided into two groups for treatment with rehabilitation plus early ACL reconstruction or rehabilitation alone with the possibility of a later operation if this was deemed necessary. After two years only 40 per cent of the latter group needed to have an ACL reconstruction.
"Despite the fact that many of the patients were active sportsmen and women, we found no difference between the treatment groups in terms of knee function, activity level or well-being two years after the injury. Neither did we find any difference in these respects when we compared those who were treated with rehabilitation alone with those who had an early operation", says Richard Frobell, researcher at Lund University, SkГҐne University Hospital and Helsingborg Hospital.
A total of 121 patients took part in the study, which was carried out in collaboration with Helsingborg Hospital and SkГҐne University Hospital in Lund. The patients were aged between 18 and 35 and had an acute ACL injury in a previously healthy knee. Professional athletes and those who did not regularly practise sport were excluded from the study. All patients underwent extensive rehabilitation, led by experienced physiotherapists.
Sixty-two patients were selected at random to also undergo surgical reconstruction of the injured ligament within four to six weeks of the injury, and 59 patients were selected at random to initially undergo treatment with rehabilitation alone. All the operations were carried out in accordance with well established methods and by experienced surgeons. The patients were examined on several occasions over two years and gave their own opinions of the status of the injured knee.
"There are almost 10 000 scientific publications addressing the ACL and 50 per cent of these are about surgical treatment. However, none of these studies have shown that surgical reconstruction produces better results than rehabilitation alone. Despite this, we perform 3 000 cruciate ligament reconstructions a year in Sweden", says Stefan Lohmander, professor and consultant at Lund University and SkГҐne University Hospital. "In the USA there are 200 000 operations of this type, at a cost of USD 3 billion!"
The research group's results have strengthened their conviction that there is no evidence to support the recommendation of ACL reconstruction as a first method of treatment.
Rehabilitation with experienced physiotherapists produces the same results as operation for more than half of the individuals in this patient group and only four out of ten need to be exposed to the risks involved in an operation.
The patients in the study will continue to be examined in order to find out whether the results are the same in the longer term and to see if there is any difference between treatments in terms of the risk of developing osteoarthritis in the knee.
Source: Lund University
среда, 1 июня 2011 г.
Lower Back Pain Cause: New Procedure Allows Diagnosis
Functional anesthetic discography (FAD), a new diagnostic procedure involving injecting anesthetic directly into a spinal disc, can be used to confirm the presence of injured discs as the source of a patient's lower back pain symptoms, according to a new study by researchers from Winthrop-University Hospital in Mineola, NY.
For the study, the researchers performed FAD in 19 consecutive patients who underwent lumbar discography for suspected disc-caused lower back pain. A total of 29 discs were injected with anesthetic and then studied afterward using MDCT and patient response. The researchers found that 19 out of the 29 discs showed a favorable response to the injection in the form of pain relief of the patient.
"We hoped that by using FAD in our practice we could isolate patients that would likely benefit from disc surgery. FAD is a functional examination; it relies on the patient's induction of pain during active patient movement, which is far different than the typical discogram. When the patient performs the movement or position that causes pain, we then inject anesthetic into the disc in hopes of relieving the pain. If the pain is or is not alleviated, then this either confirms the discogram results or proves a false negative or positive discogram, respectfully," said Jonathan Luchs, MD, lead author of the study.
The authors do caution that even though FAD seemed to work in some cases, it often actually raised more questions as to diagnosis. "Many of our patients - although a small number at this time - did have pain relief after FAD, and some even had complete pain relief. This pain relief reveals that these anesthetized discs were the source of the problem, so we view that as beneficial information for the surgeon and patient, confirming that disc surgery is in order. However, the surprising information was that not all patients had the same amount of pain relief with the anesthetic during functional motion. This led us to believe that not all of our patients suffered from merely disc disease, but their pain may be from various spinal contributors. Therefore although this is a new helpful exam that does in many cases add to the localization of back pain, it is not the final answer to diagnosing back pain," said Dr. Luchs.
The full results of the study will be presented on Tuesday, May 8, 2007 during the American Roentgen Ray Society Annual Meeting in Orlando, FL.
Contact: Necoya Lightsey
American Roentgen Ray Society
For the study, the researchers performed FAD in 19 consecutive patients who underwent lumbar discography for suspected disc-caused lower back pain. A total of 29 discs were injected with anesthetic and then studied afterward using MDCT and patient response. The researchers found that 19 out of the 29 discs showed a favorable response to the injection in the form of pain relief of the patient.
"We hoped that by using FAD in our practice we could isolate patients that would likely benefit from disc surgery. FAD is a functional examination; it relies on the patient's induction of pain during active patient movement, which is far different than the typical discogram. When the patient performs the movement or position that causes pain, we then inject anesthetic into the disc in hopes of relieving the pain. If the pain is or is not alleviated, then this either confirms the discogram results or proves a false negative or positive discogram, respectfully," said Jonathan Luchs, MD, lead author of the study.
The authors do caution that even though FAD seemed to work in some cases, it often actually raised more questions as to diagnosis. "Many of our patients - although a small number at this time - did have pain relief after FAD, and some even had complete pain relief. This pain relief reveals that these anesthetized discs were the source of the problem, so we view that as beneficial information for the surgeon and patient, confirming that disc surgery is in order. However, the surprising information was that not all patients had the same amount of pain relief with the anesthetic during functional motion. This led us to believe that not all of our patients suffered from merely disc disease, but their pain may be from various spinal contributors. Therefore although this is a new helpful exam that does in many cases add to the localization of back pain, it is not the final answer to diagnosing back pain," said Dr. Luchs.
The full results of the study will be presented on Tuesday, May 8, 2007 during the American Roentgen Ray Society Annual Meeting in Orlando, FL.
Contact: Necoya Lightsey
American Roentgen Ray Society
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