But this new study of diabetes drug doesn't prove it's safe, critics say
TUESDAY, April 1 (HealthDay News) -- The controversial diabetes drug Avandia appears to slow the progression of atherosclerosis in diabetic patients who have undergone cardiac bypass surgery, thus protecting them from new cardiac problems, according to the results of a small study.
Avandia (rosiglitazone) has been associated with increased risk of heart attack and heart failure among patients receiving the drug. In November, the U.S. Food and Drug Administration, while calling the evidence for heart attack inconclusive, agreed to keep the drug on the market, but with a black box warning about the heart attack risk.
In the new study, which included almost 100 patients taking Avandia, the study authors said they found the drug was safe and had no more cardiovascular risks than a placebo.
The VICTORY (Vein Coronary Atherosclerosis and Rosiglitazone After Bypass Surgery) study included 193 patients with type 2 diabetes who had undergone cardiac bypass surgery. They were randomly assigned to receive Avandia or a placebo. The trial was paid for by GlaxoSmithKline, the maker of Avandia.
The researchers found that after one year, patients taking Avandia had better blood sugar control, compared with those on a placebo. In addition, patients taking Avandia showed improved cholesterol levels, fewer signs of inflammation of blood vessels, and lower blood pressure than those patients taking a dummy pill.
Also, there was no significant difference in cardiovascular events between the two groups, the researchers noted.
"The enrollment of high-risk cardiovascular patients with type 2 diabetes in a placebo-controlled trial with rosiglitazone was found to have an acceptable safety profile," the researchers concluded.
The findings were presented Tuesday at the American College of Cardiology annual meeting, in Chicago.
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