Avandia Raises Risk of Heart Failure, Fractures

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And the findings are unlikely to quell an ongoing controversy about the safety of the drug, which was further fueled by a 2007 meta-analysis reporting a heightened risk of heart attacks with Avandia.

Although Home called that meta-analysis "weak," Dr. Steven Nissen, co-author of the 2007 paper and chairman of the department of cardiovascular medicine at the Cleveland Clinic, stated that the RECORD trial was "seriously flawed," citing the fact that more patients in the Avandia group were taking cholesterol-lowering statins and that group had what looked to be a high drop-out rate.

"Obviously, it is impossible to assess the safety of a drug when patients are not actually taking it," he said.

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Avandia, one of a class of medications known as thiazolidinediones, is used to lower blood sugar in patients with type 2 diabetes in combination with two other drugs, metformin and sulfonylurea.

Several earlier studies had suggested that the risk for heart failure, death and heart attack was increased with Avandia, touching off a controversy that resulted in new U.S. Food and Drug Administration-mandated label warnings about the drug.

In 2008, the advocacy group Public Citizen called for a ban on the drug, just as an American Diabetes Association/European Association for the Study of Diabetes working group unanimously advised against the use of the drug.

Presented Friday at the ADA meeting were the final results of the RECORD trial, which involved 4,447 patients with type 2 diabetes, randomly selected to take Avandia plus metformin and sulfonylurea or just metformin and sulfonylurea.

"There was better persistence of glucose control over a course of five years, an approximate doubling in heart failure and a probability that it increased death from heart failure but that is within the context of, if anything, less death and no increase in overall cardiovascular disease," Home said. "Something is balancing it out, and it may well be the reduction in the risk of stroke."

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