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 at the American Heart Association annual conference.
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. A similar COX-2 inhibitor, Vioxx, manufactured by Merck, was withdrawn from the market in September after a study indicated that the medication doubled patient risk for heart attack or stroke.
Unlike the Vioxx finding, the study with Bextra is thought by some to not be as conclusive because it looks backwards and reorganizes data from past studies in different settings. However, comments from those who participated in the Bextra study sounded firm in their conclusions. "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," stated Garret FitzGerald, the cardiologist and pharmacologist who presented the study. "Basically, we showed that Bextra is no different than Vioxx, and Pfizer is trying to suppress that information," was the comment from Curt Furberg, professor of public health sciences at the Wake Forest University School of Medicine.
Pfizer spokesperson Susan Bro said the cardiovascular problems associated with Bextra appeared only in studies that involved participants at high risk for heart disease who underwent cardiac surgery. She also added that Pfizer make the information public in October.
