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Celecoxib for colorectal adenomas increased CV events
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 Q In patients with a history of colorectal neoplasia who are at risk of recurrent adenomatous polyps, how safe is celecoxib with respect to cardiovascular (CV) events?

Clinical impact ratings GP/FP/Primary care ★★★★★★☆ IM/Ambulatory care ★★★★★★☆ Oncology ★★★★★☆☆ Gastroenterology ★★★★★☆☆ Cardiology ★★★★★☆☆

METHODS

Embedded ImageDesign:

randomised placebo controlled trial (Adenoma Prevention with Celecoxib [APC] Study).

Embedded ImageAllocation:

unclear allocation concealment.*

Embedded ImageBlinding:

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

Embedded ImageFollow up period:

2.8–3.1 years.

Embedded ImageSetting:

91 sites in the US, Canada, Australia, and the UK.

Embedded ImagePatients:

2035 patients 32–88 years of age (mean age 60y, 68% men) who had had endoscopic polypectomy to remove colorectal adenomas.

Embedded ImageIntervention:

twice daily celecoxib, 200 mg (n = 685); celecoxib, 400 mg (n = 671); or placebo (n = 679). Patients were stratified by centre and use or non-use of aspirin for CV prophylaxis.

Embedded ImageOutcomes:

composite endpoint of death from CV causes, myocardial infarction (MI), stroke, or heart failure. Secondary composite endpoints included the addition of angina and need for a CV procedure.

Embedded ImagePatient follow up:

all patients completed at least 2.8–3.1 years of follow up (intention to treat analysis).

MAIN RESULTS

The trial was stopped early with a 77% completion rate. 800 mg/day of celecoxib led to a greater risk of the CV composite endpoint than did placebo (table). The risk decreased slightly when angina (hazard ratio [HR] 2.3, 95% CI 1.1 to …

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