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Online: Vioxx Information from Merck Available on the Web
For information about Vioxx directly from Merck, visit http://www.vioxx.com/. The site posts the announcement of the withdrawal on Sept. 30, 2004, explaining that the voluntary worldwide withdrawal of VIOXX' (rofecoxib) was based on 3-year data from a prospective, randomized, placebo-controlled clinical trial, called the APPROVe (Adenomatous Polyp Prevention on Vioxx) trial. The trial, which was stopped, was designed to evaluate the efficacy of Vioxx 25 mg in preventing recurrence of colorectal polyps in patients with a history of colorectal adenomas. The announcement explains that in the study, there was an increased relative risk for confirmed cardiovascular events, such as heart attack and stroke, beginning after 18 months of treatment in the patients taking Vioxx compared with those taking a placebo. According to Merck, the results for the first 18 months of the APPROVe study did not show any increased risk of confirmed cardiovascular events on Vioxx, and in this respect, are similar to the results of two placebo-controlled studies described in the current U.S. labeling for Vioxx.
Merck describes the APPROVe study as being a multi-center, randomized, placebo-controlled, double-blind study to determine the effect of 156 weeks (3 years) of treatment with Vioxx on the recurrence of neoplastic polyps of the large bowel in patients with a history of colorectal adenoma. The trial enrolled 2600 patients and compared Vioxx 25 mg to placebo. The trial began enrollment in 2000.
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