Diabetes Drugs Boost Heart Failure But Not Death

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GlaxoSmithKline, the maker of Avandia, said the finding that Avandia does not boost users' cardiovascular death risk is not surprising.

"The findings are consistent with the results of several long-term outcomes trials with TZDs," the company noted in a statement released Thursday.

According to the drug maker, congestive heart failure is linked to fluid retention (edema), and "it is also well known that TZDs can cause some fluid retention, which can lead to, or worsen, congestive heart failure. If congestive heart failure signs and symptoms develop, and heart failure is confirmed, heart failure can be appropriately managed by a physician."

But Nesto believes that doctors should avoid prescribing these drugs to any patient with heart failure. "There are [therapeutic] alternatives where there are not these risks of heart failure," he said.

One expert agreed that the findings were familiar.

"These findings are similar to what we found in our studies," said Dr. Sonal Singh, an assistant professor of internal medicine at Wake Forest University School of Medicine in Winston-Salem, N.C. "This means that the black box warning is not enough," he said. "These drugs should be avoided in any patient at risk for heart failure," he said. "It's the nail in the coffin for using TZDs in people at risk for cardiovascular disease."

Dr. Steven Nissen, the chairman of the department of cardiovascular medicine at the Cleveland Clinic, was responsible for finding the association between Avandia and heart attack risk. He said the Lahey study failed to deal with the problem of specific risks linked to the use of these drugs.

"This new analysis does not answer the question whether the observed increase in heart failure leads to other serious complications, including death," Nissen said. "The authors did not examine the risk of cardiac death in patients who developed congestive heart failure while taking a TZD drug. Instead, they looked at overall cardiovascular mortality. This finding neither confirms, nor refutes, the hypothesis that TZDs lead to major complications of heart failure, including death," he said.