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Previous Volume 352:1071-1080 March 17, 2005 Number 11 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Supplementary Material Editorial by Drazen, J. M. Editorial by Psaty, B. M. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

ABSTRACT

Background Selective cyclooxygenase-2 (COX-2) inhibitors have come under scrutiny because of reports suggesting an increased cardiovascular risk associated with their use. Experimental research suggesting that these drugs may contribute to a prothrombotic state provides support for this concern.

Methods We reviewed all potentially serious cardiovascular events among 2035 patients with a history of colorectal neoplasia who were enrolled in a trial comparing two doses of celecoxib (200 mg or 400 mg twice daily) with placebo for the prevention of colorectal adenomas. All deaths were categorized as cardiovascular or noncardiovascular, and nonfatal cardiovascular events were categorized in a blinded fashion according to a prespecified scheme.

Results For all patients except those who died, 2.8 to 3.1 years of follow-up data were available. A composite cardiovascular end point of death from cardiovascular causes, myocardial infarction, stroke, or heart failure was reached in 7 of 679 patients in the placebo group (1.0 percent), as compared with 16 of 685 patients receiving 200 mg of celecoxib twice daily (2.3 percent; hazard ratio, 2.3; 95 percent confidence interval, 0.9 to 5.5) and with 23 of 671 patients receiving 400 mg of celecoxib twice daily (3.4 percent; hazard ratio, 3.4; 95 percent confidence interval, 1.4 to 7.8). Similar trends were observed for other composite end points. On the basis of these observations, the data and safety monitoring board recommended early discontinuation of the study drug.

Conclusions Celecoxib use was associated with a dose-related increase in the composite end point of death from cardiovascular causes, myocardial infarction, stroke, or heart failure. In light of recent reports of cardiovascular harm associated with treatment with other agents in this class, these data provide further evidence that the use of COX-2 inhibitors may increase the risk of serious cardiovascular events.

Source Information

From the Cardiovascular Division, Departments of Medicine (S.D.S., M.A.P., P.F.) and Surgery (M.B.), Brigham and Women's Hospital, Harvard Medical School, Boston; Western Infirmary, University of Glasgow, Glasgow, Scotland (J.J.V.M.); Statistics Collaborative, Washington, D.C. (J.W., R.F.); National Cancer Institute, Bethesda, Md. (W.F.A., E.H.); and Memorial Sloan-Kettering Cancer Center, New York (A.Z.).

This article was published at www.nejm.org on February 15, 2005.

Address reprint requests to Dr. Solomon at the Cardiovascular Division, Brigham and Women's Hospital, 75 Francis St., Boston, MA 02115, or at ssolomon{at}rics.bwh.harvard.edu.

Full Text of this Article

Related Letters:

Cardiovascular Risk Associated with Celecoxib
Brophy J. M., Solomon S. D., Wittes J., McMurray J., the APC Study Cardiovascular Safety Committee and Investigators , Psaty B. M., Furberg C. D.
Extract | Full Text | PDF  
N Engl J Med 2005; 352:2648-2650, Jun 23, 2005. Correspondence

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