If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  ACR: Synvisc (Hylan G-F 20) Significantly Improves Symptoms In Patients With Hip Osteoarthritis PHILADELPHIA, PA -- November 1, 2000 -- A new study presented at the 64th annual meeting of the American College of Rheumatology (ACR) shows that hip osteoarthritis patients treated with intra-articular Synvisc® (hylan G-F 20) experience significant and sustained symptomatic relief. The data provide the first clinical evidence that Synvisc, the leading viscosupplement in the United States and a proven treatment for knee osteoarthritis in more than 50 countries, may be a safe and effective treatment for reducing pain and improving functionality in patients with hip osteoarthritis. Synvisc is co-marketed by and Biomatrix, Inc., and Wyeth-Ayerst Laboratories, the pharmaceutical division of American Home Products, in the United States. Nearly 21 million Americans have osteoarthritis (OA), and OA of the hip is one of the most common forms of the condition. Viscosupplementation is a novel, drug-free treatment for OA in which fluid is injected directly into the joints to restore the biomechanical properties of the joint fluid. By improving the joint's elasticity and viscosity, viscosupplementation provides shock absorption and lubrication to cushion and protect the joint, thus reducing pain and increasing mobility. This past September, ACR added viscosupplementation to its newly revised treatment guidelines for knee OA. According to the new guidelines, when patients do not receive adequate pain relief from exercise, physical therapy and simple analgesics, viscosupplementation therapy is one therapeutic option, depending on the individual patient. "The study presented today at ACR shows that Synvisc holds tremendous promise as a safe and effective treatment for OA hip symptoms," said Biomatrix's vice president of medical affairs, Francois Bailleul, M.D., who worked closely with the lead investigators in the trial. "The results support further large scale validation to show how Synvisc may help patients with hip OA return to their normal, active lives without the need for drug therapies." The new data come from an open, prospective, multi-center pilot study that evaluated the safety and efficacy of viscosupplementation with Synvisc to treat hip OA symptoms. The study involved 57 patients age 40 or over with primary hip OA for more than one year, in accordance with ACR criteria. Patients included were grade II or III on the Kellgren-Lawrence scale, indicating mild to moderate radiological changes, and had a walking pain score of 50 mm to 90 mm on a 100 mm Visual Analog Scale (VAS), indicating moderate to severe pain. Patients received 2 ml of Synvisc injected into the hip under fluoroscopic control, with all 57 patients receiving a first injection, and 32 patients receiving a second and final injection either on day 30, 60, or 90 if their mean walking pain returned to levels prior to treatment. Efficacy and safety were evaluated on days 7, 30, 60, and 90, after each injection. Primary efficacy was measured by assessments of walking pain on VAS. 45% of the patients received just one injection of Synvisc and showed dramatic decreases in walking pain during 3 months (p<0.0001), with their pain relief sufficient to warrant only one injection. Patients who received a second injection benefited from it and also showed significant pain decreases at endpoint (p<= 0.0001). Secondary efficacy was determined by patient self-rating assessments of pain using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score, a test designed to capture the essential elements of pain, stiffness, and physical disability in patients with OA of the knee and/or hip. Secondary efficacy measures also included patient and physician global evaluations on VAS. All secondary efficacy measures showed highly statistically significant trends in favor of Synvisc therapy for treating hip OA. Safety was measured by local and systemic tolerance at each visit. Transient target hip painful local reactions were reported after the injections. No serious systemic adverse events were attributable to the device. "This study is an important step to expand the clinical applications of Synvisc," said Endre Balazs, MD, chief executive officer and chief scientific officer of Biomatrix, Inc. "We believe the positive results from the trial will help to make this important therapy available to a broad range of patients with OA and will benefit those patients who wish to maintain a more vibrant, active lifestyle." OA is the most common form of arthritis in the United States, primarily affecting women, overweight people, and people age 50 and over. It is a chronic, progressive disease that affects the joints, especially the knee and hip. During OA, fluid in the joint thins and loses its normal ability to provide shock absorption and lubrication, and the cartilage that covers the bones begins to rub together and degrade. As a result, people experience pain in the hips, groin, or inner thigh, as well as stiffness and loss of flexibility, thereby restricting normal activities such as walking, moving and bending. Medication, walking devices such as canes, and exercise can help to reduce the stress and subsequent pain of hip OA. However, if the pain is too severe and other methods do not help, total hip replacement surgery may be necessary. According to the American Academy of Orthopaedic Surgeons, there are approximately 135,000 annual total hip replacement surgeries performed in the United States, with more than half -- 80,000 surgeries -- performed on women. Synvisc is used to relieve OA 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 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 help to restore mobility for patients at all stages of knee OA. In addition, Synvisc therapy has proven a successful alternative to total knee replacement surgery for some patients. In clinical trials and post market vigilance, mild to moderate transient local pain, swelling, and/or effusion occurred after intra-articular injections of Synvisc. Systemic adverse effects were reported rarely under circumstances where causal relationship to Synvisc was uncertain. 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.
|
