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Rofecoxib (Vioxx) was withdrawn from the market after cardiovascular toxicity was noted during a chemoprevention trial that was underway for adenoma prevention. Three trials in which cardiovascular risks associated with cyclooxygenase (COX)-2 inhibitors were reported were published in the New England Journal of Medicine; two of these were performed primarily for evaluating COX-2 inhibitors' role in preventing colorectal adenoma.
In the celecoxib (Celebrex) adenoma prevention trial, patients were randomized to placebo or celecoxib (200 mg or 400 mg) twice daily. Cardiovascular death, nonfatal myocardial infarction, stroke, or heart failure occurred in 7 of 679 placebo recipients (1%), in 16 of 685 200-mg celecoxib recipients (2.3%; hazard rat…