Doctors Not Ready to Abandon Diabetes Drug

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The authors of the New England Journal of Medicine study, Dr. Steven E. Nissen and Kathy Wolski of the Cleveland Clinic, acknowledged limitations with their study. Nissen, a cardiologist, earlier uncovered cardiac problems with muraglitazar, a drug in the same class as Avandia. He was also an early critic of the arthritis drug Vioxx, which was pulled from the market in 2004 after studies showed it increased the risk of heart attack and stroke.

"Realistically, the data [on Avandia] is not that strong, and everyone is busy reevaluating the primary data from which this is drawn," Banerji said. "We will know much more in the next few weeks."

For the new study, Nissen and Wolski evaluated 42 studies that compared patients taking Avandia with patients not using the drug, which is used to regulate insulin and blood sugar in people with type 2 diabetes. The studies included almost 28,000 patients, 15,560 of whom were taking Avandia.

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The study found that the risk of a heart attack was increased 43 percent among those taking Avandia, and there was a 64 percent greater risk of dying from cardiovascular causes.

GlaxoSmithKline responded by issuing a press release Monday defending the safety of the drug. Company officials said GSK "strongly disagrees with the conclusions reached in the New England Journal of Medicine article, which are based on incomplete evidence and a methodology that the author admits has significant limitations."

More than 2 million people worldwide take Avandia for type 2 diabetes, generating $3.2 billion in annual sales for GlaxoSmithKline, according to published reports. The drug was first approved for the treatment of type 2 diabetes in 1999.

"Avandia is very widely used because it affects one of the fundamental problems of diabetes, which is insulin resistance," Banerji said. "It increases the ability of insulin, which is a good thing."

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