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Risk Of Colorectal Polyps Recurrence Can Be Controlled By Rofecoxib

e taking placebo (41 percent vs 55 percent; p<0.0001; relative risk 0.76; 95 percent CI 0.69-0.83). Rofecoxib also reduced the risk of advanced adenomas, which are polyps that are more likely to become cancerous (p<0.01). The benefit was larger in the first year (RR 0.65; 95 percent CI 0.57-0.73) than in the subsequent two years (RR = 0.81, 95 percent CI 0.71-0.93). In the year following three years’ treatment, patients taking rofecoxib experienced a slightly increased risk of any adenoma, but not of advanced adenomas. However, over the entire length of the trial (three years of treatment and one year off drug), patients taking rofecoxib experienced a reduction of the risk of any adenoma.

About the Study
The study included 2,587 evaluable patients with a recent history of confirmed colorectal polyps followed at 108 sites in the United States and abroad. After removal of all polyps, patients were randomized to receive either placebo or 25 mg rofecoxib (the average daily recommended dose) on a daily basis. The primary endpoint was all polyps diagnosed during the three-year treatment period based upon colonoscopies conducted one year and three years after baseline. In addition, an extension to the APPROVe study was conducted to assess recurrence of adenomas in the year following the end of the three years’ treatment through colonoscopy at year four.

Patients treated with rofecoxib experienced more serious adverse events, including significant upper gastrointestinal events and, as reported previously, increased risks of thrombotic cardiovascular events (Bresalier et al. Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial. NEJM 2005;352:1092-102). Dr. Baron does not believe that the side effects will derail the eventual development of effective chemoprevention.

'While the toxicity of the currently available COX-2 inhibitors may be problematic, the demonstration of efficacy certainly imp
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