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Rofecoxib for colorectal adenomas increased thrombotic events

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 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 ★★★★★★☆


Embedded ImageDesign:

randomised placebo controlled trial (Adenomatous Polyp Prevention on Vioxx [APPROVe] Trial).

Embedded ImageAllocation:

unclear concealment.*

Embedded ImageBlinding:

blinded (clinicians, patients, judicial assessors of outcomes, and monitoring committee).*

Embedded ImageFollow up period:

3 years.

Embedded ImageSetting:

108 centres in 29 countries.

Embedded ImagePatients:

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.

Embedded ImageIntervention:

rofecoxib, 25 mg/day (n = 1287), or placebo (n = 1299) for 3 years.

Embedded ImageOutcomes:

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, …

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