Merck & Co (West Point, Pa) withdrew rofecoxib (Vioxx) from the market on September 30, 2004, based on unpublished data from their own APPROVe trial (2004), a randomized placebo-controlled study of 2600 patients (mean age, 60 years) with a history of adenomatous polyps who were taking 25 mg of rofecoxib daily. Only a minority of these patients had a known history of coronary artery disease. In fact, those with ischemic events in the prior year were excluded from the study. Patients randomized to rofecoxib were found to have an approximately 2-fold increase in the rate of cardiovascular events compared with those randomized to placebo. Merck reported that this difference did not become statistically significant until 18 months after study inception.
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