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Glaxo: Diabetes Pill Does Not Raise Heart Risk

Posted on: Wednesday, 6 June 2007, 06:00 CDT

By Rita Rubin

The maker of the popular diabetes pill Avandia reported Tuesday that an analysis of an ongoing study found the drug was no more likely to raise heart attack risk than older treatments.

However, the authors of a trio of accompanying editorials say they are not convinced of Avandia's safety, mainly because the study is too small to show a statistically significant difference between Avandia and the two older drugs against which it is being compared.

This is the second time in two weeks that The New England Journal of Medicine has posted a study about Avandia's effect on heart attack risk.

On May 21, the journal posted a paper in which Steven Nissen, chair of cardiovascular medicine at the Cleveland Clinic, pooled the results of 42 small, short-term studies and concluded that Avandia raised the risk of heart attack or hospitalization for blocked coronary arteries by about 40%.

The new study's release fell on the eve of a hearing today by the House Committee on Oversight and Government Reform looking at how well the Food and Drug Administration assessed Avandia's safety. Chairman Henry Waxman, D-Calif., scheduled the hearing after learning of Nissen's finding.

The new study, conducted by an independent review board charged with monitoring safety in a Glaxo-sponsored trial comparing Avandia with two other older diabetes drugs, found that patients on Avandia had an 8% higher risk of being hospitalized or dying as a result of cardiovascular problems. The difference was not statistically significant, the authors wrote.

The trial has followed 4,447 European patients an average of 3.75 years, according to the report. The study assigned 2,220 patients to receive Avandia along with metformin or sulfonylurea, while 2,227 patients took the older drugs.

A total of 217 patients in the Avandia group and 202 patients in the metformin plus sulfonylurea group were hospitalized or died as a result of cardiovascular problems. The numbers were so low that the difference could have been the result of chance.

Therein lies the problem, David Nathan, head of the Diabetes Center at Massachusetts General Hospital, and Wake Forest University medical epidemiologist Curt Furberg said in interviews. They wrote two of the accompanying editorials.

The designers of the Avandia trial thought the rate of heart attacks would be higher, so they didn't need a huge number of patients in the study to show what the risk was. But because they overestimated the number of heart attacks, they enrolled too few patients to find a statistically significant difference between the two treatment groups, Nathan said.

And, Furberg said, about 10% of patients in the study were lost to follow-up -- "unheard of" in studies sponsored by the National Institutes of Health. (c) Copyright 2005 USA TODAY, a division of Gannett Co. Inc.

Source: USA TODAY

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