Treatment of patients with osteoarthritis with rofecoxib compared with nabumetone.

摘要: BACKGROUND Rofecoxib and nabumetone were developed to provide gastrointestinal benefits over traditional nonsteroidal antiinflammatory drugs (NSAIDs). However, there is limited comparative information relating these 2 drugs. OBJECTIVE The objective of this study was compare rofecoxib nabumetone, at their lower, recommended doses, in patients with osteoarthritis (OA). METHODS Nine hundred seventy-eight knee OA a positive history NSAID response randomized 12.5 mg per day (N=390), 500 twice (N=392), or placebo (N=196) for 6 weeks. primary efficacy end point percent "good" "excellent" Patient Global Assessment Response Therapy (PGART) week 6; PGART also evaluated days 1 6. Additional points included investigator assessment response, pain walking weeks, joint tenderness, discontinuation as result lack efficacy, quality life. Adverse experiences (AEs) collected. RESULTS Significantly more (50.4%) than (43.3%, P=0.043) (29.5%, P 124 hours, P<0.001). Results similar all additional except both which the treatment group demonstrated better results. There significantly (P<0.050) overall serious AEs discontinuations resulting from nabumetone. Five one had confirmed thrombotic cardiovascular events (P=0.123). Information on published, prespecified pooled analysis here completeness. CONCLUSIONS At starting doses OA, agents effective placebo. dosage 1000 known be responders. occurred Considering data other recent safety regarding cyclooxygenase-2 selective nonselective NSAIDS, physicians must make risk/benefit assessments each individual patient when considering use agents, by U.S. Food Drug Administration.