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Rofecoxib increased risk of CV events in patients with history of colorectal adenomas ⩾1 year after stopping treatmentRofecoxib increased risk of CV events in patients with history of colorectal adenomas ⩾1 year after stopping treatment

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STUDY DESIGN

Design:

randomised controlled trial (RCT) (The Adenomatous Polyp Prevention on Vioxx [APPROVe] study). ClinicalTrials.gov NCT0282386.

Allocation:

unclear.*

Blinding:

blinded (patients, clinicians, and outcome assessors).*

STUDY QUESTION

Setting:

108 centres worldwide.

Patients:

2587 patients ⩾40 years of age (mean age 59 y, 62% men) who had ⩾1 histologically confirmed large bowel adenoma removed in the 12 weeks before study entry and no known remaining polyps in the bowel after complete colonoscopy. Exclusion criteria included need for chronic non-steroidal anti-inflammatory drug treatment; uncontrolled hypertension (>165/95 mm Hg); angina or congestive heart failure; myocardial infarction (MI), coronary angioplasty, or coronary arterial bypass grafting in the past year; and …

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