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| |  ACR: Synvisc (Hylan G-F 20) Effective In Reducing Knee Osteoarthritis Pain PHILADELPHIA, PA -- November 1, 2000 -- A groundbreaking randomized outcome study presented today at the 64th annual meeting of the American College of Rheumatology (ACR) provides conclusive evidence that adding Synvisc® (hylan G-F 20) to a standard treatment regimen for knee patients with osteoarthritis significantly decreases pain and improves function and quality of life, compared to standard treatment alone. The data show that patients who received Synvisc as part of a standard care regimen based on the ACR's 1995 treatment guidelines scored significantly higher on all primary and secondary pain and mobility effectiveness measures, compared to patients receiving a standard treatment regimen without Synvisc. The 1995 guidelines included such therapies as intra-articular steroid injections, acetaminophen, and NSAIDs, as well as surgical intervention. Synvisc, a viscosupplementation product, is a novel treatment for osteoarthritis in which fluid that resembles the joint fluid of healthy 18 to 27 year olds is injected directly into the knee to replace the osteoarthritic fluid. The injection helps restore the joint fluid's healthy properties. It reduces pain and improves mobility by adding shock absorption and lubrication to improve the joint's elasticity and viscosity. The release of the data comes on the heels of ACR's announcement of a new treatment paradigm for knee osteoarthritis, a condition that afflicts 9.5 million Americans. This past September, ACR released newly revised treatment guidelines -- the first since 1995 -- that included viscosupplementation for the first time. According to the revised guidelines, when patients do not receive adequate pain relief from exercise, physical therapy or simple analgesics (acetaminophen), then viscosupplementation therapy, an NSAID, or a COX selective agent may be used, depending on the individual patient. "The study presented today at ACR is the first randomized outcome trial to demonstrate the statistically significant and clinically important benefits of making Synvisc available to knee osteoarthritis patients," said Charles Goldsmith, a member of the independent steering committee and Professor of Biostatistics from the Department of Clinical Epidemiology & Biostatistics at McMaster University and The Centre for Evaluation of Medicines at St. Joseph's Hospital in Hamilton, Ontario. "It is also the first Synvisc study with statistically significant improvement in standard quality of life scales." "We're very pleased with the execution of this study, which was conducted to high scientific standards," added another investigator, George Torrance, Professor Emeritus of Clinical Epidemiology & Biostatistics at McMaster University and The Centre for Evaluation of Medicines at St. Joseph's Hospital. "Moreover, the study results support the recent decision by ACR to include viscosupplementation in its recommendations for management of patients with knee osteoarthritis." The data come from a prospective, randomized, controlled multi-site health outcomes trial involving 255 patients with radiographically confirmed osteoarthritis. The study examined patients who received treatment according to ACR's 1995 guidelines for management of knee osteoarthritis. One hundred and twenty-seven patients were randomized to appropriate care with Synvisc and 128 patients were randomized to appropriate care without Synvisc. Patients were evaluated over a one-year period. Study results showed that the Synvisc-treated group was statistically superior to the non-Synvisc-treated group for all primary and secondary effectiveness and quality of life measures. "We are extremely pleased to see such consistency among all the outcome measures evaluated," said Professor Goldsmith. The primary effectiveness measure was patient assessment of pain using the Western Ontario and McMaster Universities Osteoarthritis Index 3.0 (WOMAC) pain score. WOMAC measures clinically important changes in pain, stiffness, and physical disability following physiotherapy, pharmacological, or surgical interventions in patients with osteoarthritis of the knee or hip joints. Secondary effectiveness was measured by the percentage of improved patients, and global assessments of knee osteoarthritis, overall osteoarthritis, and overall health. Quality of life was measured by using the SF 36 (Short-Form 36) health-related quality of life questionnaire, and Health Utilities Index (HUI) preference-based quality of life questionnaire. The HUI was developed by McMaster University investigators. The study also showed an important Synvisc safety benefit. The Synvisc-treated group had a statistically significant and clinically important decrease in gastrointestinal side effects. Osteoarthritis is the most common form of arthritis in the United States, primarily affecting women, overweight people, and those age 50 years and over. Osteoarthritis is a chronic, progressive disease that affects the joints, especially the knee. In fact, 80 percent of people with osteoarthritis report limitations in movement or activities. It is estimated that nearly 9.5 million Americans and about 1 million Canadians suffer from knee osteoarthritis, which occurs when fluid in the knee joint thins and loses its normal ability to provide shock absorption and lubrication. Additionally, the cartilage that covers the bones begins to rub together and break down. As a result, patients experience pain and loss of flexibility in their knees, making it difficult to perform normal physical activities. Synvisc® is used to relieve osteoarthritic knee pain in patients who do not get adequate relief from exercise, physical therapy, or simple painkillers. Synvisc has similar shock-absorbing and lubricating properties as the joint fluid of healthy, young 18 to 27 year olds. One course of treatment with Synvisc -- three doctor-administered injections over 15 days -- can provide pain relief for months and helps to restore mobility in patients at all stages of the disease. In addition, Synvisc has been able to delay total knee replacement surgery in some patients. There are approximately 215,000 total knee replacement surgeries performed each year, according to the American Academy of Orthopedic Surgeons. In clinical trials, mild to moderate transient local pain, swelling or effusion occurred in 2.2 percent of intra-articular injections of Synvisc. Systemic adverse effects were reported rarely and did not recur with repeat Synvisc injection. During intra-articular administration, strict adherence to aseptic technique must be followed to avoid joint infection. Physicians should use caution when injecting Synvisc into patients who are allergic to avian protein, feathers or egg products.
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