A prospective, 3-year comparative observational study compared the risk of cardiovascular events in patients with osteoarthritis or rheumatoid arthritis prescribed celecoxib or a nonsteroidal antiinflammatory drug (NSAID).
Patients prescribed celecoxib (n=5,470) or NSAIDs (n=5,059) between November 1, 2007, and July 31, 2008 in 1,084 hospitals and clinics in Japan were eligible for safety analysis. Mean (standard deviation) observation for the celecoxib group was 716 (420) days and 692 (426) days for the NSAID group (P=0.004). Composite I (adjudicated cardiovascular adverse events of myocardial infarction, angina pectoris, heart failure, cerebral infarction, cerebral hemorrhage) number of events (percentage) and rate/1,000 person years was 66 (1.2%) and 6.2 (10,745 person years), respectively, for the celecoxib and 65 (1.3%) and 6.8 (9,601 person years) for the NSAID (P=0.58) groups. Composite II (all cardiovascular events) number of events (percentage) and rate/1,000 person years was 79 (1.4%) and 7.4, respectively, for the celecoxib and 84 (1.7%) and 8.8 for the NSAID (P=0.26) group. Adjusted Cox hazards ratio (95% confidence interval) was 0.89 (0.63-1.27; P=0.52) for Composite I, 0.87 (0.63-1.19; P=0.39) for Composite II and 1.03 (0.75-1.41; P=0.87) for death from all causes.
After adjustment for confounding variables, celecoxib was not associated with an increase of cardiovascular risk in comparison with nonselective NSAID in Japanese patients with rheumatoid arthritis or osteoarthritis in an observational setting.