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Editorial
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Volume 352:1133-1135 March 17, 2005 Number 11
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COX-2 Inhibitors — Lessons in Drug Safety
Bruce M. Psaty, M.D., Ph.D., and Curt D. Furberg, M.D., Ph.D.

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Approximately six years after the cyclooxygenase-2 (COX-2) inhibitors were approved for use in the United States, the results of three randomized, placebo-controlled trials provide new evidence about the cardiovascular risks of rofecoxib, celecoxib, and valdecoxib.1,2,3 The Adenomatous Polyp Prevention on Vioxx (APPROVe) trial, a study of patients with a history of colorectal adenomas, was stopped early because rofecoxib doubled the risk of major cardiovascular events (relative risk, 1.92; 95 percent confidence interval, 1.19 to 3.11). These findings confirmed the increased risk of myocardial infarction previously seen in the Vioxx Gastrointestinal Outcomes Research (VIGOR) trial4 and some observational studies.5 The public . . . [Full Text of this Article]


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From the Cardiovascular Health Research Unit, Departments of Medicine, Epidemiology, and Health Services, University of Washington, Seattle (B.M.P.); and the Department of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, N.C. (C.D.F.).

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


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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