Diabetes group president questions Avandia study

GlaxoSmithKline’s diabetes drug Avandia has sparked debate over its potential to boost the risk of heart attacks, at the annual meeting of the American Diabetes Association.

An analysis published in the New England Journal of Medicine in May found that Avandia increased the risk of heart attack by 43% and the risk of heart death by 64% amongst users. Glaxo refuted the findings.

The study’s author, Steven Nissen, cardiology chief at the Cleveland Clinic, defended the findings, which were collected from 46 Avandia studies involving nearly 28,000 patients. “When you see this kind of consistency in data, it makes you believe that something real is going on,” Nissen commented.

However, the breadth of studies used as evidence by Nissen prompted criticism. John Buse, chief of endocrinology at the University of Chapel Hill, North Carolina and president-elect of the diabetes group, said, “the remaining question is, if you take a study not designed to look at heart attacks, can you make a conclusion?”

Avandia is part of the same thiazolidinedione drug class as Rezulin, which was pulled from the market in 2000 after 60 people died from acute liver failure.

US regulators are calling for stronger warnings on Avandia. An FDA advisory panel is to study the drug’s safety issues at a meeting in July.