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In September and December 2004, when rofecoxib (Vioxx) and celecoxib (Celebrex) were reported to cause adverse cardiovascular events among patients enrolled in colorectal polyp prevention trials, much of our information came from the media and the drug companies. Now, the New England Journal of Medicine has published formal reports from those studies, plus a new report on valdecoxib (Bextra).
In the APPROVe trial, 2586 patients with colorectal adenomas were randomized to receive rofecoxib (25 mg daily) or placebo. At 3 years, the incidence of thrombotic events (mainly cardiac and cerebrovascular) was significantly higher in the rofecoxib group than in the placebo group (3.6% vs. 2.0%). This increased risk became apparent during the last 18 m…