THERAPEUTICS
Rofecoxib increased risk of CV events in patients with history of colorectal adenomas 
1 year after stopping treatment
| The first 150 words of the full text of this article appear below. |
STUDY DESIGN
randomised controlled trial (RCT) (The Adenomatous Polyp Prevention on Vioxx [APPROVe] study). ClinicalTrials.gov NCT0282386.
unclear.*
blinded (patients, clinicians, and outcome assessors).*
STUDY QUESTION
108 centres worldwide.
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 stroke or transient ischaemic attack in the past 2 years.
rofecoxib, 25 mg/day (n = 1287), or matching placebo (n = 1300) for 3 years.
included the composite end point of MI, stroke, or vascular death; vascular death; and all-cause mortality.
median 4.4 years (1 y after stopping treatment).
84% (intention-to-treat
Chinese University of Hong Kong, Hong Kong, China
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