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Older Diabetics Using Avandia Face Increased Death Risk
Date:12/11/2007

Canadian study also found those over 65 more likely to have heart trouble with drug

TUESDAY, Dec. 11 (HealthDay News) -- Older patients using the diabetes drug Avandia faced an increased risk of heart attack, heart failure and even death, new research shows.

According to the Canadian authors of the study, which is published in the Dec. 12 issue of the Journal of the American Medical Association, this is the first population-based look at the class of drugs to which Avandia belongs and the first report to find an increase in mortality rates.

"Our study looked at an older population in the real world who tend to be underrepresented in research trials and are at higher risk," said study author Dr. Lorraine L. Lipscombe, a researcher with the Institute for Clinical Evaluative Sciences in Toronto. "While the overall risk versus benefit is difficult to interpret in all people, in older people, the risks may outweigh the benefit."

"This is very striking data," added Dr. Steven Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic Foundation. "This and other studies are going to put tremendous pressure on the FDA [U.S. Food and Drug Administration] to act more forcefully with regard to Avandia."

But the maker of Avandia (rosiglitazone), GlaxoSmithKline, took issue with the findings.

In a prepared statement, the company said the Canadian study "has significant limitations and generates misleading conclusions regarding acute myocardial infarction and death. These conclusions are inconsistent with a more robust body of evidence from large, long-term, prospective, well-designed clinical studies, including ADOPT and RECORD. These long-term trials in diabetic patients comparing rosiglitazone to other oral anti-diabetic medicines show no increased risk for cardiovascular events compared to other commonly used medications, other than the well-known risk of congestive hea
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