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Previous Volume 352:1081-1091 March 17, 2005 Number 11 Next

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

ABSTRACT

Background Valdecoxib and its intravenous prodrug parecoxib are used to treat postoperative pain but may involve risk after coronary-artery bypass grafting (CABG). We conducted a randomized trial to assess the safety of these drugs after CABG.

Methods In this randomized, double-blind study involving 10 days of treatment and 30 days of follow-up, 1671 patients were randomly assigned to receive intravenous parecoxib for at least 3 days, followed by oral valdecoxib through day 10; intravenous placebo followed by oral valdecoxib; or placebo for 10 days. All patients had access to standard opioid medications. The primary end point was the frequency of predefined adverse events, including cardiovascular events, renal failure or dysfunction, gastroduodenal ulceration, and wound-healing complications.

Results As compared with the group given placebo alone, both the group given parecoxib and valdecoxib and the group given placebo and valdecoxib had a higher proportion of patients with at least one confirmed adverse event (7.4 percent in each of these two groups vs. 4.0 percent in the placebo group; risk ratio for each comparison, 1.9; 95 percent confidence interval, 1.1 to 3.2; P=0.02 for each comparison with the placebo group). In particular, cardiovascular events (including myocardial infarction, cardiac arrest, stroke, and pulmonary embolism) were more frequent among the patients given parecoxib and valdecoxib than among those given placebo (2.0 percent vs. 0.5 percent; risk ratio, 3.7; 95 percent confidence interval, 1.0 to 13.5; P=0.03).

Conclusions The use of parecoxib and valdecoxib after CABG was associated with an increased incidence of cardiovascular events, arousing serious concern about the use of these drugs in such circumstances.

Source Information

From the Texas Heart Institute at St. Luke's Episcopal Hospital, Houston (N.A.N.); Universal Clinical Research Center and Johns Hopkins University School of Medicine, Baltimore (A.A.W.); Pfizer, Global Research and Development, Ann Arbor, Mich. (M.T.B., K.M.V.); St. Bartholomew's Hospital, London (R.M.L.); the Department of Anesthesiology and Intensive Care Medicine, University of Bonn, Bonn, Germany (A.H.); Queen's University and Kingston General Hospital, Kingston, Ont., Canada (J.L.P.); and Washington Hospital Center, Washington, D.C. (S.W.B.).

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

Address reprint requests to Dr. Nussmeier at the Texas Heart Institute at St. Luke's Episcopal Hospital, P.O. Box 20345, MC 1-226, Houston, TX 77225-0345, or at nnussmeier{at}heart.thi.tmc.edu.

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