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Rofecoxib, a cyclooxygenase-2 inhibitor (coxib), was withdrawn from the market in 2004 after researchers reported that patients in the active-treatment arm of APPROVe, a randomized controlled trial for prevention of recurrent colorectal adenomas, had a higher risk for cardiovascular events than did placebo patients. Investigators now describe the effect of rofecoxib on adenomas in that trial.
A total of 2587 patients (age, ≥40) with histories of histologically confirmed adenomas were randomized to receive daily rofecoxib (25 mg) or placebo for 3 years. The primary endpoint was recurrent adenomas diagnosed at 1- and 3-year colonoscopic examinations. The recurrence rate for adenomas was lower in the rofecoxib group than in the placebo group (4…