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Large, Long-Term Study Shows Avandia Has No Increased Overall Cardiovascular Risk Compared to Other Commonly Used Diabetes Medicines
Date:6/5/2009

RECORD trial also demonstrates durable blood sugar control over time with Avandia

LONDON, RESEARCH TRIANGLE PARK, N.C., and NEW ORLEANS, June 5 /PRNewswire/ -- Clinical trial results presented today at the American Diabetes Association annual meeting show that overall rates of cardiovascular hospitalization and cardiovascular death are similar in patients taking Avandia (rosiglitazone) compared to those receiving metformin and sulfonylurea.

Results from the 4,447-patient Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes (RECORD) study, which was sponsored by GlaxoSmithKline, Avandia's maker, were also published online today in the medical journal The Lancet.

RECORD is a large, prospective, randomized, controlled study that was initiated in 2001, and designed to compare cardiovascular outcomes of patients on Avandia added to metformin or sulfonylurea to those on metformin and sulfonylurea. The study confirmed its primary hypothesis. It showed that cardiovascular hospitalization or cardiovascular death (which includes heart attack, congestive heart failure, and stroke) was not statistically different between the two groups after an average of 5.5 years of therapy. This translates into 321 events (14.5 percent) among patients receiving Avandia compared to 323 events (also 14.5 percent) for patients receiving control medications (hazard ratio=0.99, 95% confidence interval=0.85 to 1.16) (Data on the individual components are provided below.)

"RECORD provides a robust assessment of rosiglitazone's cardiovascular safety and achieving the study's primary endpoint leads us to conclude that rosiglitazone carries no increased risk of overall cardiovascular death or hospitalization compared to the most commonly used diabetes medicines, metformin and sulfonylurea, which have been used for decades," said Dr. Philip D. Home, chairman of the RECORD Steering Committ
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SOURCE GlaxoSmithKline
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