"No safety issues were identified in this high-cardiovascular-risk population," says Olivier F. Bertrand, MD, of Laval University in Quebec City, Canada.
The drug did not slow the progression of plaque buildup over the 12-month study period, which was the primary goal of the study.
However, there were some signs the drug was helping, Bertrand says. People taking Avandia had lower blood sugar levels, higher levels of HDL "good" cholesterol, and lower levels of a blood marker of inflammation known as C-reactive protein, compared with those on a placebo. The diabetes drug also had favorable effects on blood clotting.
Bertrand presented the findings here at the American College of Cardiology's annual meeting.
The findings are reassuring in light of concerns that the class of drugs to which Avandia and Actos belong may increase heart risks, says Robert Eckel, MD, a past president of the American Heart Association and a professor of endocrinology at the University of Colorado.
One study last year suggested Avandia may increase a person's risk of heart attack and death from heart disease. Then later in the year, the FDA mandated that both Avandia and Actos carry a "black box" warning that the drugs may trigger heart failure.
GlaxoSmithKline, which makes Avandia, funded the trial.