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Celebrex is indicated to reduce the number of adenomatous colorectal polyps in Familial Adenomatous Polyposis (FAP), as an adjunct to usual care (e.g., endoscopic surveillance, surgery). It is not known whether there is a clinical benefit from a reduction in the number of colorectal polyps in FAP patients. It is also not known whether the effects of Celebrex treatment will persist after Celebrex is discontinued. The efficacy and safety of Celebrex treatment in patients with FAP beyond six months have not been studied. Recommended dosage p>Usual medical care for FAP patients should be continued while on Celebrex. To reduce the number of adenomatous colorectal polyps in patients with FAP, the recommended oral dose is 400 mg twice per day to be taken with food. Use lowest effective dose for the shortest duration consistent with treatment goals for the individual patient.Clinical Studies Celebrex was evaluated to reduce the number of adenomatous colorectal polyps. A randomized, double-blind, placebo-controlled study was conducted in patients with FAP. The study population included 58 patients with a prior subtotal or total colectomy and 25 patients with an intact colon. Thirteen patients had the attenuated FAP phenotype. One area in the rectum and up to four areas in the colon were identified at baseline for specific follow-up, and polyps were counted at baseline and following six months of treatment. The mean reduction in the number of colorectal polyps was 28% for Celebrex 400 mg twice daily, 12% for Celebrex 100 mg twice daily and 5% for placebo. The reduction in polyps observed with Celebrex 400 mg twice daily was statistically superior to placebo at the six-month timepoint (p=0.003). |
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