Study 4 (n=1062) Celebrex 3.9% 2.4% 1.8% 7.0% 200 mg BID (13/337) ? (7/296) ? (5/274) ? (25/356) ? ---------------------------------------------------------------------------------------- Diclofenac 5.1% 3.3% 2.9% 9.7% 75 mg BID (18/350) (10/306) (8/278) (36/372) ---------------------------------------------------------------------------------------- Ibuprofen 13.0% 6.2% 9.6% 23.3% 800 mg TID (42/323) (15/241) (21/219) (78/334) _______________________________________________________ *p 0.05 Celebrexvs. naproxen based on interval and cumulative analyses ? p0.05 Celebrex vs. ibuprofen based on interval and cumulative analyses One randomized and double-blind 6-month study in 430 RA patients was conducted in which an endoscopic examination was performed at 6 months. The incidence of endoscopic ulcers in patients taking CELEBREX 200 mg BID was 4% vs 15% for patients taking diclofenac SR 75 mg BID (p<0.001). In 4 of the 5 endoscopic studies, approximately 11% of patients (440/4,000) were taking aspirin (325 mg/day). In the CELEBREX groups, the endoscopic ulcer rate appeared to be higher in aspirin users than in non-users. However, the increased rate of ulcers in these aspirin users was less than the endoscopic ulcer rates observed in the active comparator groups, with or without aspirin. The correlation between findings of endoscopic studies, and the relative incidence of clinically significant serious upper GI events has not been established. Serious clinically significant upper GI bleeding has been observed in patients receiving CELEBREX in controlled and open-labeled trials, albeit infrequently (see Use with Aspirin and WARNINGS - Gastrointestinal (GI) Effects). | ||||
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