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More Trouble for Avandia

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More trouble for Avandia, as a new study finds it isn’t much better at reducing plaque buildup in the arteries than an older, generic diabetes drug. The results of this new Avandia clinical trial, released yesterday at the American Heart Association Meeting in New Orleans, has once again raised questions about the expensive diabete’s drugs usefulness.

Avandia’s been in trouble since May 2007, when an analysis of 42 clinical trails published by the Cleveland Clinic showed that patients taking the drug had a 43-percent higher risk of having a heart attack. In November 2007, the Food & Drug Administration (FDA) finally ordered that a black box warning detailing Avandia’s heart related risk be added to the drug’s labeling.

Late last month, the group Public Citizen said it had identified 14 cases of Avandia-induced liver failure in the FDA’s Adverse Event Reporting System. Of the 14 cases of liver failure, 12 resulted in deaths. Those findings prompted Public Citizen to file a petition with the FDA asking that Avandia be removed from the market.

“The scientific evidence against Avandia is overwhelming,” Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said in a news release. “The timing of these findings should give the FDA the momentum it needs to act swiftly to prevent further needless deaths and health damage by banning this drug.”

This latest study, which involved 672 patients, compared Avandia’s impact on arterial plaque buildup – a condition called atherosclerosis – to the drug glipizide. After 18 months of treatment, those who took Avandia had an 0.21 percent reduction in plaque at the observed artery, while glipizide patients experienced an 0.43 percent increase in plaque. While Avandia fared somewhat better, the difference is not statistically significant.

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