Pfizer COX-2 Inhibitor Bextra Increases Heart Risk, Study Finds
The COX-2 inhibitor Bextra, manufactured by Pfizer, doubles patient risk for heart attack or stroke, according to the preliminary results of a University of Pennsylvania study presented on Tuesday at the American Heart Association annual conference in New Orleans, the New York Times reports. The study examined data from 5,930 participants in 12 clinical trials that involved Bextra. According to the study, participants who took Bextra experienced heart attacks or strokes 2.19 times as often as those who took a placebo. Merck withdrew the COX-2 inhibitor Vioxx from the market in September after a "longer and better-controlled study" indicated that the medication doubled patient risk for heart attack or stroke, according to the Times. However, the new Bextra study "is not nearly as persuasive as the trial that led to Vioxx's withdrawal because it is backward-looking and simply reorganizes data presented in other settings" the Times reports.
Reaction
Garret FitzGerald, the cardiologist and pharmacologist who presented the study, said, "The magnitude of the signal with Bextra is even higher than what we saw in Vioxx. This is a time bomb waiting to go off." Curt Furberg, professor of public health sciences at the Wake Forest University School of Medicine, added, "Basically, we showed that Bextra is no different than Vioxx, and Pfizer is trying to suppress that information." According to Pfizer spokesperson Susan Bro, the cardiovascular problems associated with Bextra appeared only in studies that involved participants at high risk for heart disease who underwent cardiac surgery. She added that Pfizer make the information public in October (Harris, New York Times, 11/10).
