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New Study: Avandia Riskier Than Actos

More Deaths, Heart Failure, Strokes in Elderly Patients Taking Diabetes Drug Avandia vs. Actos

Heart Attack Risk in Question

Earlier studies have suggested that Avandia may increase patients' risk of heart attacks -- findings that GSK categorically disputes.

The Graham study found no increased risk of heart attack in elderly patients. That, he says, is likely because too few elderly patients survive heart attacks long enough to make it to the hospital.

"We find patients taking Avandia have a higher risk of death than those taking Actos, but there is no way Avandia is causing death from all causes," Graham says. "The leading causes of death in older people are heart attack, stroke, lung disease, dementia, and cancer. It's far more likely that Avandia is causing older people to die more from heart attacks than from cancer or dementia or something else."

But Avandia does indeed increase overall heart attack risk, asserts another paper by Cleveland Clinic researchers Steven E. Nissen, MD, and Kathy Wolski, MPH. Their new analysis of 56 Avandia clinical trials essentially updates their controversial  2007 paper, which ignited a firestorm over Avandia safety.

Now Nissen and Wolski again find Avandia increases the risk of heart attacks. Again, GSK disputes the finding.

What's Next for Avandia?

GSK says it's looking forward to defending Avandia safety at the July 13-14 meeting of an FDA outside-expert advisory panel. The panel's charge: To evaluate Avandia and Actos safety and to make recommendations to the FDA on possible actions.

The Graham study, and the Juurlink editorial, were published online ahead of print on June 28 by the Journal of the American Medical Association. The Nissen paper appears in Archives of Internal Medicine, published online ahead of print on June 28.

Neither Graham, his colleagues, nor Juurlink report funding from or financial interest in GSK or Takeda, which makes Actos. Nissen consults for a number of pharmaceutical companies, including Takeda, through the Cleveland Clinic Center for Clinical Research. He has all honoraria or other fees contributed directly to charity so he derives no tax benefit.

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