Diabetes Drugs Boost Heart Failure But Not Death

Experts split on what this means for those taking Avandia, Actos.

By Steven Reinberg
HealthDay Reporter
Saturday, September 29, 2007; 12:00 AM

Copyright © 2007 ScoutNews, LLC. All rights reserved.

THURSDAY, Sept. 27 (HealthDay News) -- The widely used diabetes drugs Avandia and Actos increase the risk for heart failure for patients with type 2 diabetes, but they do not raise the risk for cardiovascular death, U.S. researchers report.

The findings add to the controversy around these medications, which belong to a class of blood sugar-lowering drugs called thiazolidinediones (TZDs).

The higher danger of heart failure linked to Avandia and Actos resulted in the U.S. Food and Drug Administration (FDA) requiring the makers of these drugs place a "black box" warning on the labels of these medications.

In July, an FDA panel mulled removing Avandia from the market but then recommended against such a move. At the time, the panel said that the evidence linking Avandia to an increased risk for heart attack was not conclusive.

"There has been a lot of controversy and confusion about the use of these two drugs," noted the lead researcher of the new study, Dr. Richard Nesto, chair of the department of cardiovascular medicine at the Lahey Clinic Medical Center, in Burlington, Mass.

In their study, published in the Sept. 29 issue of The Lancet, Nesto's group collected data on more than 20,000 patients who had participated in seven clinical trials and received Avandia or Actos.

Nesto's team found a 72 percent increase risk of congestive heart failure among a wide range of patient types -- for example, those with so-called "pre-diabetes" or full-blown type 2 diabetes but without cardiovascular disease, those with type 2 diabetes and cardiovascular disease, and patients with type 2 diabetes and an already documented history of congestive heart failure.

However, the risk of cardiovascular death for these patients was not increased with either of the two drugs, Nesto's group found.

"That's an important observation," Nesto said. "What it means is that, even despite the risk of heart failure in some patients and despite analysis that showed there might be an increased risk of heart attack, we did not find an increased risk of death from cardiac causes. So, this should be somewhat reassuring," he said.