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- adenomatous polyps
- cardiovascular diseases
- colorectal neoplasms
- cyclooxygenase inhibitors
- pyrazoles
- sulfonamides
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
Design:
randomised placebo controlled trial (Adenoma Prevention with Celecoxib [APC] Study).
Allocation:
unclear allocation concealment.*
Blinding:
blinded (clinicians, patients, judicial assessors of outcomes, and monitoring committee).*
Follow up period:
2.8–3.1 years.
Setting:
91 sites in the US, Canada, Australia, and the UK.
Patients:
2035 patients 32–88 years of age (mean age 60y, 68% men) who had had endoscopic polypectomy to remove colorectal adenomas.
Intervention:
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.
Outcomes:
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).
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 …