Synvisc Effective Treatment for Knee and Hip Osteoarthritis
(64th Annual Meeting of the American College of Rheumatology) Results of two separate studies provided evidence that adding hylan G-F 20 (Synvisc) to a standard treatment regimen in patients with osteoarthritis of the knee or hip significantly reduces pain and improves function and quality of life compared with standard treatment alone. Synvisc, a viscosupplementation product, is a drug-free treatment for osteoarthritis in which fluid that resembles the joint fluid of healthy persons 18 to 27 years of age is injected directly into the knee or hip to restore the biochemical properties of joint fluid. In a prospective, randomized, multisite study, 255 patients with radiographically confirmed osteoarthritis of the knee were randomized to appropriate care with Synvisc (127 patients) or appropriate care without Synvisc (128 patients) and evaluated over a one-year period. Patients who received Synvisc were statistically superior to patients in the appropriate care-only group for all primary and secondary pain and mobility effectiveness measures and quality-of-life measures. Primary effectiveness was assessed using the Western Ontario and McMaster Universities Osteoarthritis Index 3.0 (WOMAC) pain score. Secondary effectiveness was measured by the percentage of improved patients, global assessment of knee osteoarthritis, overall osteoarthritis and overall health. Quality of life was measured using the Short-Form 36 health-related quality-of-life questionnaire and Health Utilities Index (HUI) preference-based quality-of-life questionnaire. Patients receiving Synvisc had a statistically significant decrease in gastrointestinal side effects. Another open, prospective, multicenter study evaluated the efficacy of Synvisc in treating patients with hip osteoarthritis. Patients were included if they were at least 40 years of age, had hip osteoarthritis for at least one year, were grade II or III on the Kellgren-Lawrence scale (indicating mild to moderate radiologic 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]). All 57 patients received an initial injection of 2 mL of Synvisc into the hip under fluoroscopic control, and 32 of these patients received a second and final injection at either 30, 60 or 90 days postinjection if their mean walking pain score returned to a pretreatment level. Efficacy and safety were measured on days 7, 30, 60 and 90 after each injection. Primary efficacy was measured by assessing walking pain on VAS. Forty-five percent of patients demonstrated sufficient walking pain relief to require only one injection and patients receiving two injections showed significant decreases in walking pain at the end of the study. Secondary efficacy was measured by patient self-rating assessments of pain using the WOMAC pain score and patient and physician global evaluations on VAS, and all showed statistically significant trends in patients receiving Synvisc. Safety was measured by local and systemic tolerance at each visit, with transient target hip painful locations being reported after the injections. No serious systemic adverse effects were noted.–CHARLES GOLDSMITH, M.SC., PH.D., ET AL., McMaster University, Hamilton, Ontario, Canada, and endre balazs, m.d., Biomatrix, Ridgefield, New Jersey.
COPYRIGHT 2001 American Academy of Family Physicians
COPYRIGHT 2001 Gale Group