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Celecoxib Update: Cardiovascular Risk vs. Polyp-Prevention Benefit

Given the cardiovascular risks of celecoxib, should it have any role for prevention of colorectal cancer?

The Adenoma Prevention with Celecoxib (APC) study documented a roughly threefold greater risk for major cardiovascular events at 3 years with celecoxib (at 200 or 400 mg twice daily) than with placebo in patients who had histories of colorectal adenomas and endoscopic polypectomy (see Journal Watch Cardiology Apr 1 2005). Now, we have the 3-year data on colorectal-polyp prevention from APC, which was co-funded by celecoxib’s manufacturer and the National Cancer Institute.

Compared with the placebo group, the celecoxib groups had significantly lower incidences of any colorectal adenoma (38%–43% vs. 61%) and of advanced adenomas (6%–8% vs. 17%). The incidence of serious cardiovascular events with celecoxib was roughly triple that with placebo (about 3% vs. 1%).

Another trial of celecoxib (400 mg once daily) for prevention of colorectal polyps, an exclusively manufacturer-funded study known as PreSAP, also showed significant advantages of the drug over placebo at 3 years: 34% versus 49% incidence of any colorectal adenoma, and 5% versus 10% incidence of advanced adenomas. The increased risk for serious cardiovascular events with celecoxib (2.5% vs. 1.9%) was not statistically significant.

Comment: The benefit of celecoxib for preventing development of colorectal adenomas comes with substantial risk for cardiovascular events. On balance, given that preventing adenomas is not equivalent to preventing cancer, the risk-benefit ratio does not favor use of the drug for this purpose.

— Harlan M. Krumholz, MD, SM

Published in Journal Watch Cardiology September 6, 2006

Citation(s):

Bertagnolli MM et al. for the APC Study Investigators. Celecoxib for the prevention of sporadic colorectal adenomas. N Engl J Med 2006 Aug 31; 355:873-84.

• Original article (Subscription may be required)
• Medline abstract (Free)

Arber N et al. for the PreSAP Trial Investigators. Celecoxib for the prevention of colorectal adenomatous polyps. N Engl J Med 2006 Aug 31; 355:885-95.

• Original article (Subscription may be required)
• Medline abstract (Free)

Psaty BM and Potter JD. Risks and benefits of celecoxib to prevent recurrent adenomas. N Engl J Med 2006 Aug 31; 355:950-2.

• Original article (Subscription may be required)
• Medline abstract (Free)