New Study Finds No Significant Heart Attack Risk From Diabetes Drug

TUESDAY, June 5 (HealthDay News) -- Results of a new drug-company funded study show no significant increased risk for heart attack or death from heart disease associated with Avandia, the widely used diabetes drug.

The British study, released Tuesday by theNew England Journal of Medicine, follows last month's study in the same journal by Dr. Steven E. Nissen and Kathy Wolski of the Cleveland Clinic, which found a significant -- up to 43 percent-- increased risk of cardiovascular deaths and heart attack from the drug.

The latest study was released by the journal early to coincide with a Congressional hearing Wednesday that will focus on the drug's safety risks.

The British researchers saw no increased risk for cardiac events among those taking Avandia (generic name rosiglitazone) and those not taking it.

"Overall, there was no significant difference between those on rosiglitazone and those not on rosiglitazone," said study co-author Stuart J. Pocock, of the London School of Hygiene & Tropical Medicine. "The concern about cardiovascular death, I think we have clearly deflated. The concern on heart attack -- our data are modifying that concern, but it's still inconclusive," he said.

But one expert thinks that any risk is too great, and there is no need to use the drug.

"These current data do not reassure me; in fact, they make me more concerned that there may be a problem here," said Dr. David M. Nathan, of Massachusetts General Hospital, and author of an accompanying editorial in the journal.

On May 21, the U.S. Food and Drug Administration responded to concerns in the Nissen-Wolski study by issuing a safety alert for the drug. But it stopped short of asking for a stronger warning label, saying more analysis was needed.

The hearing Wednesday, by the House Committee on Oversight and Government Reform, will focus in part on the FDA's actions. The committee is chaired by Rep. Henry Waxman, D-Calif., a frequent critic of the agency.

In Pocock's trial, researchers randomly selected 4,447 people with type 2 diabetes to receive rosiglitazone or metformin plus other drugs. During 3.75 years of follow-up, 217 people taking rosiglitazone and 202 patients taking metformin either died or were hospitalized due to heart disease.

"If you look at deaths, including cardiovascular deaths, there were slightly more deaths in the control group than among those taking rosiglitazone," Pocock said. "That's very assuring."

While there was no "significant" difference in heart attacks between the two groups, there were slightly more heart attacks among people taking rosiglitazone, Pocock said.