Cardiovascular Risk Associated with Celecoxib in a Clinical Trial for Colorectal Adenoma Prevention
Scott D. Solomon, M.D., John J.V. McMurray, M.D., Marc A. Pfeffer, M.D., Ph.D., Janet Wittes, Ph.D., Robert Fowler, M.S., Peter Finn, M.D., William F. Anderson, M.D., M.P.H., Ann Zauber, Ph.D., Ernest Hawk, M.D., M.P.H., Monica Bertagnolli, M.D., for the Adenoma Prevention with Celecoxib (APC) Study Investigators
Background Selective cyclooxygenase-2 (COX-2) inhibitors havecome under scrutiny because of reports suggesting an increasedcardiovascular risk associated with their use. Experimentalresearch suggesting that these drugs may contribute to a prothromboticstate provides support for this concern.
Methods We reviewed all potentially serious cardiovascular eventsamong 2035 patients with a history of colorectal neoplasia whowere enrolled in a trial comparing two doses of celecoxib (200mg or 400 mg twice daily) with placebo for the prevention ofcolorectal adenomas. All deaths were categorized as cardiovascularor noncardiovascular, and nonfatal cardiovascular events werecategorized in a blinded fashion according to a prespecifiedscheme.
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.
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.
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N Engl J Med 2005;
352:2648-2650, Jun 23, 2005.
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