Clinical–alimentary tractA Randomized Trial of Rofecoxib for the Chemoprevention of Colorectal Adenomas
Section snippets
Materials and Methods
The Adenomatous Polyp PRevention On Vioxx (APPROVe) trial was a randomized, double-blind, placebo-controlled trial of the efficacy of oral rofecoxib, 25 mg/day, to prevent colorectal adenomas. For regulatory purposes, the main study hypothesis was that 3 years of treatment with rofecoxib would reduce the adenoma risk among higher-risk subjects, that is, those with at least one of the following at baseline: an adenoma 1 cm or greater in estimated diameter, an adenoma with villous or
Results
Overall, 3260 patients were screened for study; 2587 were randomized to rofecoxib 25 mg or placebo (Figure 1). Seventeen subjects found not to have at least 1 colorectal adenoma on uniform pathology review were dropped from efficacy analyses, leaving 1277 subjects randomized to rofecoxib and 1293 randomized to placebo. There were no substantial differences between treatment groups in demographic, lifestyle, or clinical characteristics (Table 1). Overall, 2015 (78.4%) subjects met the criteria
Discussion
In this large, randomized, double-blind clinical trial, we found that rofecoxib significantly reduced the 3-year risk of recurrent adenomas among patients with a recent adenoma history. Risk reduction for advanced lesions was similar to that for all adenomas. There was a suggestion that subjects presenting with advanced adenomas may experience less benefit in terms of relative risk than those with small tubular adenomas only. The chemopreventive effect did not appear to differ according to
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Cited by (0)
Supported by Merck Research Laboratories.
The authors are indebted to the study subjects for their cooperation and enthusiasm.