Glaxo's diabetes drug falls short on heart disease
MINNEAPOLIS - GlaxoSmithKline PLC's diabetes drug Avandia, linked to heart attacks in a study last year, failed to slow the progression of heart disease better than an older medicine, a company funded study found.
The study of diabetics found that those taking Avandia, known chemically as rosiglitazone, for 18 months had less artery-clogging plaque, though the improvement wasn't greater than in people taking glipizide, a cheaper, 20-year-old medication. Diabetes is known to raise a person's risk of developing heart disease.
Avandia sales plummeted 23 percent in the third quarter to $313 million from a year earlier after reports the drug increased the risk of heart attacks. While Avandia patients didn't worsen in the trial, called Approach, the findings probably won't ease doctors' safety concerns, said Steven Nissen, head of cardiology at the Cleveland Clinic in Ohio.
"The Approach trial was too small to confirm or refute the safety issues previously raised for rosiglitazone," said Nissen, who conducted the study that uncovered the initial concerns with Avandia. "The failure of the Approach trial provides one more reason to use rosiglitazone with caution."
The study was reported yesterday at the American Heart Association meeting in New Orleans. The Approach study peered inside the arteries of 672 patients with diabetes using a procedure known as intravascular ultrasound that measures plaque buildup.
In the study, those on Avandia had higher cholesterol levels, lower blood pressure, and less inflammation.
The trial was the largest ever conducted using IVUS in diabetic patients with heart disease.
"This adds real data to a controversy over the past year," said Richard Nesto, the lead author and an associate professor of cardiovascular medicine at Lahey Clinic in Burlington, Mass., in an interview. "It's reassuring that there is no direct effect on the coronary arteries that one would consider adverse. We can safely say the drug does not increase atherosclerosis." 