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Friday September 10, 2010

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Glaxo Study Finds Avandia Doesn’t Increase Heart Attack Risk; Critics Aren’t Convinced

A new study released today and sponsored by drug maker GlaxoSmithKline PLC finds the company’s controversial diabetes drug Avandia does not boost the risk of heart attack.

However, a host of researchers and physicians are criticizing the findings of the company-sponsored research and saying the study is deeply flawed.

The study, called Record, defies the findings of about 10 other studies dating back several years, which have found a link between Avandia and deadly heart attacks. One prominent 2007 report put a serious dent in the number of Avandia prescriptions due to concerns about deadly side effects.

Record focused on about 4,000 diabetics and examined patients taking Avandia along with other diabetes drugs alongside other patients taking cheaper, more conventional diabetes drugs, such as metforim.

The study found that Avandia may double the risk of heart failure compared to older diabetes medications, but that the drug does not increase the risks of cardiovascular death and stroke.

Independent Researchers Not Convinced

The physician who published the 2007 study which found a 43-percent increase in heart attack risk among Avandia patients called the Record study “seriously flawed,” according to a Reuters report.

Dr. Steve Nissen said for one thing, not enough patients remained in the Record to conclude that Avandia does not increase the risk of heart attacks and other cardiovascular problems.

Hundreds of former Avandia patients have filed personal-injury lawsuits against Glaxo for marketing a drug they say caused severe injury and death. The Food and Drug Administration has warned about serious injury from Avandia since 2007.

Heart failure is a chronic condition in which the heart, unable to pump enough blood through the body, suddenly fails, causing death. Avandia also has been linked to an increased risk of severe bone fractures.

The results of Record were presented this week at the American Diabetes Association and published by the online medical journal Lancet.

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