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news.Further bad news in the COX-2 inhibitors saga has emerged, as new trial data from Penn Medicine has shown that Pfizer's Bextra increased the risk of heart attack and stroke three-fold in bypass surgery patients.
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In a statistical meta-analysis of two placebo-controlled trials, Bextra elevated the combined incidence of heart attack and stroke three-fold in coronary artery bypass graft (CABG) surgery patients.
In another analysis, the investigators also found that a fat produced by COX-1 speeds hardening of the arteries in a mouse model of atherosclerosis, which may have implications for low-dose aspirin therapy in heart patients.
Six years ago, Dr Garret FitzGerald, director of the Institute for Translational Medicine and Therapeutics at Penn, raised the possibility that selective COX-2 inhibitors might predispose patients otherwise at risk for an increased incidence of heart attack and stroke. This proposal was based initially on his studies of how Pfizer’s Celebrex and Merck & Co’s Vioxx worked in human volunteers.
The first unequivocal evidence of this risk emerged with the Merck-sponsored APPROVe study of Vioxx, leading to withdrawal of the drug in September 2004. Evidence implicating a second member of the class, Bextra, was presented by FitzGerald in November 2004.