Avandia's Heart Risk Higher Than Others in Its Class

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For the study, Winkelmayer's team collected data on more than 28,000 diabetic patients aged 65 and older who were taking Avandia or Actos between 2000 and 2005. Among these patients, 50.3 percent took Actos and 49.7 percent took Avandia.

After a little more than a year on the medications, 1,869 patients died. The researchers found that patients taking Avandia had a 15 percent higher rate of death compared with patients taking Actos. In addition, Avandia patients had a 13 percent greater risk of heart failure than patients on Actos.

GlaxoSmithKline defended its drug in a statement on the new research released Monday.

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The company "strongly supports the safety and efficacy of Avandia based on extensive clinical trial experience and widespread post-marketing use. This new study is inconsistent with evidence from randomized clinical trials and has significant limitations," the statement said.

A randomized clinical trial -- in which participants are randomly grouped and then followed prospectively over time -- is typically considered more reliable than an observational study, which is not as well-controlled.

"The primary outcome in this observational analysis is all-cause mortality," the company statement added. "The Avandia prescribing information includes data from RECORD, an ongoing long-term randomized clinical trial that has shown no statistically significant differences between the Avandia group and the control group regarding death from cardiovascular causes or any cause."

The continuing controversy over the heart risks of these diabetes drugs began with a 2007 study, published in the New England Journal of Medicine, in which heart expert Dr. Steven E. Nissen, chairman of the Cleveland Clinic's department of cardiovascular medicine, reported a 43 percent increased risk of heart attack among patients taking Avandia.

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