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Avandia, the world's top-selling oral diabetes drug, significantly increases the risk of heart attacks, a prominent cardiologist said in an article that the New England Journal of Medicine deemed important enough to post on its Web site Monday, weeks before the scheduled print publication date.
Dr. Steven Nissen, a cardiologist at the Cleveland Clinic and the article's lead author, pored through summaries of dozens of studies and found a 43 percent higher risk of diabetics suffering a heart attack if they took Avandia compared with other drugs or sugar pills. Dr. Nissen was unable to determine whether the risk is affected by how long Avandia is used or how much is taken.
GlaxoSmithKline, which manufactures Avandia to treat type 2 diabetes, the most common form of the disease, said it stands by the drug's safety and called the findings of Dr. Nissen and a Cleveland Clinic statistician "flawed." The company said other clinical trials contradict the report's conclusions, including one that examined medical records for 33,000 diabetics.
Since the Food and Drug Administration approved Avandia in 1999, doctors have written tens of millions of prescriptions for the drug. Last year, Avandia generated $3.1 billion in sales worldwide.