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Two Large, Independent Outcomes Trials Offer New Important Safety Information on Cardiovascular Effects of AVANDIA(R)
Date:6/9/2008

than predicted.

In the trial, investigators said that they were "more aggressive" with AVANDIA and other medications in the intensive arm to achieve and maintain tight glycemic targets. The investigators found that in VADT, there were no increased deaths associated with any of the medications used in the trial, including AVANDIA.

Findings from ACCORD

ACCORD, which investigated whether or not intensive blood control would reduce CV events in patients with type 2 diabetes who had either established cardiovascular disease or additional CV risk factors, was presented at a press conference during the ADA Scientific Sessions and published simultaneously in the New England Journal of Medicine. The study had a mean follow-up of 3.5 years. In total, 7,623 patients enrolled in the ACCORD trial took AVANDIA, representing more than 19,200 patient years of experience with the medication.

The investigators found that, as compared with standard therapy, the use of intensive therapy to reach the study's A1C goal for 3.5 years did not significantly reduce major CV events. Although they found an increase in CV deaths among these high-risk patients who were in the intensive arm, the death rates from ACCORD were substantially lower than investigators predicted at the outset of the trial.

In their analysis, the investigators noted that "preliminary nonprespecified exploratory analyses of episodes of severe hypoglycemia after randomization and differences in the use of drugs (including rosiglitazone), weight change, and other factors did not identify an explanation for the mortality finding."

Additionally, an accompanying editorial in the New England Journal of Medicine states, " ... the ACCORD trial investigators concluded that patients in the standard-control group and those in the intensive-control group had similar risks and rates of death, whether or not they were prescribed rosiglitazone."

Other Studies of AVANDIA

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SOURCE GlaxoSmithKline
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