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SHHEEESH

Pfizer COX-2 Inhibitor Bextra Increases Heart Risk, Study Finds

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http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=26672

   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).

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