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New Study: Avandia Riskier Than Actos

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

Switch to Actos? continued...

How big a risk is this really? For every 60 older patients who take Avandia instead of Actos for one year, there would be one extra heart attack, heart failure, stroke, or death.

"If you are a patient currently being treated with Avandia, based on the data from our study it would be wise for you to contact your doctor and ask to be switched to a safer alternative," Graham says. "Even if you have been on Avandia for a while and have not had anything bad happen to you, why take those risks? They are completely unnecessary."

Graham is an outspoken safety advocate within the FDA. He stresses that his opinions are his own and not those of the FDA. He and his colleagues researched, wrote, and published the current study themselves. Despite partial funding by the FDA, the federal agency had no role in conducting, designing, or publishing the study.

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.

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