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| |  AAOS: Celebrex (Celecoxib) Effective In Treating Ankle Sprains SAN FRANCISCO, CA -- March 6, 2001 -- Two new investigational studies presented in a satellite symposium at the 68th annual meeting of the American Association of Orthopaedic Surgeons (AAOS) showed Celebrex (celecoxib capsules) was superior to placebo and as effective as ibuprofen and naproxen in treating the signs and symptoms of ankle sprains. Ankle sprains are one of the most common injuries in the U.S., affecting 27,000 people daily. These common acute soft-tissue injuries often result in swelling, pain, and inflammation. These two multicenter, randomized, double-blind studies were conducted among 443 patients in the United States and 397 patients in Canada, France and Belgium. Celebrex is the only COX-2 specific inhibitor indicated for the treatment of both osteoarthritis and adult rheumatoid arthritis, however, is not approved for the treatment of ankle sprain. In the U.S. study, Celebrex 400 mg daily (n=147) was compared to ibuprofen 2400 mg daily (n=155) or placebo (n=141) over 10 days of treatment. The second study assessed Celebrex 400 mg daily (n=198) versus naproxen 1000 mg daily (n=198) over eight days of treatment. In both studies, patients had grade 1 or 2 ankle sprains and moderate to severe pain on weight bearing (> 45 mm, 100 mm Visual Analog Scale) at baseline. Primary measures of efficacy were the Patient’s Global Assessment of Ankle Injury and the Patient’s Assessment of Ankle Pain Visual Analog Scale (VAS), two efficacy measurements used to assess a patient’s response to ankle injury treatment. Other efficacy measures included time to return to Normal Function/Activity, the Physician’s Global Assessment of Ankle Injury and the Patient’s and Physician’s Satisfaction Assessments. Results showed that Celebrex was statistically superior in efficacy to placebo and comparable in efficacy to ibuprofen and naproxen in the main outcome efficacy measures in improving the signs and symptoms of ankle sprains. "These two studies suggest that Celebrex is well tolerated and may be effective in treating the signs and symptoms of ankle sprain injuries ¾ one of the most common injuries in the U.S.," said Evan Ekman, M.D., the principal investigator and director of Southern Orthopaedic Sports Medicine in Columbia, S.C. Celebrex is the only COX-2 specific inhibitor approved for osteoarthritis (OA) and adult rheumatoid arthritis (RA). Celebrex should not be taken by patients who have aspirin-sensitive asthma or allergic reactions to aspirin or other arthritis medicines or certain sulfa drugs called sulfonamides, or who are in their third trimester of pregnancy. As with all NSAIDs, serious GI tract ulcerations can occur without warning symptoms. Physicians and patients should remain alert to the signs and symptoms of GI bleeding. Celebrex does not affect platelet function and therefore should not be used for cardiovascular prophylaxis. In clinical studies the most common side effects of Celebrex were dyspepsia, diarrhea and abdominal pain, which were generally mild to moderate.
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