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

SAN FRANCISCO, June 9 /PRNewswire/ -- Two long-term, large-scale and independent studies evaluating cardiovascular (CV) outcomes in people with type 2 diabetes enrolled more than 9,300 patients taking AVANDIA(R) (rosiglitazone maleate) and provide more than 20,000 patient years of additional experience with AVANDIA. The Veterans Affairs Diabetes Trial (VADT), through two separate analyses, concluded that based on results from VADT, there is no evidence to suggest that use of AVANDIA increases the risk for CV mortality and morbidity in patients with type 2 diabetes. A second trial, The Action to Control Cardiovascular Risk in Diabetes (ACCORD), found that AVANDIA was not associated with any increased risk of death. These findings display a safety profile consistent with results from other long-term studies with AVANDIA. These studies were presented during the 68th Scientific Sessions of the American Diabetes Association (ADA) in San Francisco, CA.

"The findings on AVANDIA should be reassuring to physicians who prescribe AVANDIA and patients who use AVANDIA for their type 2 diabetes," added R. Paul Aftring, MD, PhD, AVANDIA Clinical Lead at GlaxoSmithKline. "The safety findings on AVANDIA from these two trials add substantial patient experience to the large body of existing evidence on the safety profile of the medication."

Findings from VADT

VADT evaluated whether intense blood sugar control in patients with type 2 diabetes would reduce major CV events. The study continued for 7.5 years. In total, 1,704 patients enrolled in VADT took AVANDIA.

The primary result of VADT did not show that intensive blood sugar control (HbA1c levels below 7%) had a statistically significant effect on reducing major CV events associated with diabetes. However, there was a favorable trend in reducing all CV events, except CV death and inoperable heart disease, among the patients in the intensive arm. There were significantly fewer CV events in the trial
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SOURCE GlaxoSmithKline
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