The risk of cardiovascular thrombotic events with selective cyclooxygenase‐2 inhibitors
Abstract
The selective cyclooxygenase-2 (COX-2) inhibitors celecoxib and rofecoxib are now widely prescribed instead of the traditional nonsteroidal antiinflammatory agents (NSAIDs). Short-term randomized controlled trials (RCTs) documented that both agents were superior to placebo, with comparable efficacy and better upper gastrointestinal (GI) adverse-event profiles than traditional NSAIDs, including ibuprofen, naproxen, and diclofenac. However, these RCTs were not powered to demonstrate GI tolerability equivalent to placebo, and consequently the GI warning common to the NSAID class remained in both celecoxib and rofecoxib labels. The Celecoxib Long-term Arthritis Safety Study (CLASS) and the Vioxx Gastrointestinal Outcomes Research (VIGOR) trials were designed to demonstrate GI safety superior to that of traditional NSAIDs, as used in regular clinical practice, assessed by “clinically meaningful” upper GI events, at twice recommended clinical doses for long-term use (celecoxib 400 mg twice daily; rofecoxib 50 mg daily) (1,2). Although both large outcome trials shared similar designs, they differed in several important aspects (Table 1). Comparator NSAIDs in CLASS were ibuprofen and diclofenac, and in VIGOR it was naproxen. Only patients with rheumatoid arthritis (RA) were enrolled in VIGOR; in CLASS, RA patients represented 28% of the study population, and osteoarthritis (OA) patients represented the other 72%. Enrolled patient numbers were similar: in CLASS, 3,987 patients took…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 4,047 participants or records.
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