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Large, Long-Term Veterans Affairs Diabetes Trial (VADT) Reveals Important Cardiovascular Safety News on AVANDIA(R)
Date:6/8/2008

Primary Findings from VADT on Benefit of Intensive Blood Sugar Control Are Not Statistically Significant but Show Favorable Trend in Reducing Most CV

Events

SAN FRANCISCO, June 8 /PRNewswire/ -- Findings from the Veterans Affairs Diabetes Trial (VADT), a large, long-term and independent cardiovascular (CV) outcomes study in high-risk diabetes patients were released today at the 68th Scientific Sessions of the American Diabetes Association (ADA). According to news announced by the ADA, AVANDIA(R) (rosiglitazone maleate) was used in a majority of patients in the study and was not associated with increased deaths. These safety data are consistent with results from other long-term studies with 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, it was found that there was a favorable trend in reducing all CV events, except CV death, among the patients in the intensive arm.

"Given the size and duration of this trial, the data on AVANDIA offer important safety information to physicians treating patients with type 2 diabetes," said Farhad Zangeneh, MD, FACP, FACE, assistant clinical professor of medicine at the George Washington University in Washington, DC and medical director of the Endocrine, Diabetes & Osteoporosis Clinic in Sterling, VA.

Dr. Zangeneh added, "While the VADT did not meet its primary endpoint, it is critical that these results do not detract from what we already know about the benefits of long-term blood sugar control on other serious and potentially life-threatening complications of diabetes, such as kidney failure, blindness and amputation."

In VADT, the patient population was considered at higher risk for CV disease since more than 40% had prior CV events. Further, trial participants had other risk factors, including hypertensi
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SOURCE GlaxoSmithKline
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