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In 2004, sale of the intensively marketed cyclooxygenase-2 inhibitor rofecoxib (Vioxx) was stopped after a manufacturer-conducted, placebo-controlled study of its effect on recurrence of adenomatous colorectal polyps revealed an apparent doubling of thrombotic cardiovascular events in the rofecoxib arm during treatment or within 14 days after treatment ended. With funding from the manufacturer, an independent group has now provided extended follow-up of cardiovascular outcomes data.
Initially, 2587 patients with previous colorectal adenomas were randomized to 3 years of daily treatment with rofecoxib (25 mg) or placebo. At least 1 year after treatment ended, investigators telephoned 2166 patients or their proxies to determine occurrences of …