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- adenomatous polyps
- cardiovascular diseases
- colorectal neoplasms
- cyclooxygenase inhibitors
- lactones
- sulfones
- thrombosis
Q In patients with colorectal adenomas who are at risk of recurrent adenomatous polyps, how safe is rofecoxib with respect to thrombotic events?
Clinical impact ratings GP/FP/Primary care ★★★★★☆☆ IM/Ambulatory care ★★★★★☆☆ Oncology ★★★★★☆☆ Gastroenterology ★★★★☆☆☆ Cardiology ★★★★★★☆
METHODS
Design:
randomised placebo controlled trial (Adenomatous Polyp Prevention on Vioxx [APPROVe] Trial).
Allocation:
unclear concealment.*
Blinding:
blinded (clinicians, patients, judicial assessors of outcomes, and monitoring committee).*
Follow up period:
3 years.
Setting:
108 centres in 29 countries.
Patients:
2586 patients ⩾40 years of age (mean age 59 y, 62% men) who had ⩾1 histologically confirmed large bowel adenoma removed within 12 weeks of study entry and did not require long term non-steroidal anti-inflammatory drug (NSAID) therapy. Exclusion criteria: uncontrolled hypertension; angina or congestive heart failure; myocardial infarction (MI), coronary angioplasty, or coronary artery bypass grafting in the previous year; or stroke or transient ischaemic attack (TIA) in the previous 2 years.
Intervention:
rofecoxib, 25 mg/day (n = 1287), or placebo (n = 1299) for 3 years.
Outcomes:
thrombotic events (fatal and nonfatal MI, unstable angina, sudden death from cardiac causes, fatal and non-fatal ischaemic stroke, TIA, peripheral arterial thrombosis, peripheral venous thrombosis, and pulmonary embolism). The endpoint of the Antiplatelet Trialists’ Collaboration (APTC) study was also analysed (combined incidence of death from cardiovascular, …