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- adenomatous polyps
- cardiovascular diseases
- colorectal neoplasms
- cyclooxygenase inhibitors
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 ★★★★★☆☆
randomised placebo controlled trial (Adenoma Prevention with Celecoxib [APC] Study).
unclear allocation concealment.*
blinded (clinicians, patients, judicial assessors of outcomes, and monitoring committee).*
Follow up period:
91 sites in the US, Canada, Australia, and the UK.
2035 patients 32–88 years of age (mean age 60y, 68% men) who had had endoscopic polypectomy to remove colorectal adenomas.
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.
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.
Patient follow up:
all patients completed at least 2.8–3.1 years of follow up (intention to treat analysis).
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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