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May
21, 2007--Rosiglitazone
is widely used for treatment of type 2 diabetes. In a NEJM
study published online May 21, Steven
E. Nissen and Kathy Wolski concluded rosiglitazone was
associated with a significant increase in the risk of
myocardial infarction and with an increase in the risk of
death from cardiovascular causes that had borderline
significance. Despite their study’s limitations,
the authors urged patients and providers to consider the
potential for serious adverse cardiovascular effects of
treatment with rosiglitazone for type 2 diabetes. NEJM
In
an accompanying editorial, Bruce
M. Psaty and Curt D. Furberg write that the
rationale for prescribing rosiglitazone at this
time is unclear, and unless new data provide a
different picture of the risk-benefit profile
that regulatory action by the FDA is now warranted. They
also said, to the extent that the findings of Nissen and
Wolski represent a valid estimate of the risk
of cardiovascular events, “rosiglitazone represents a
major failure of the drug-use and drug-approval
processes in the United States.” NEJM
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