Avandia Provides No Significant Benefit in Reduction of Artery Plaque

According to new research presented yesterday at the American Heart Association’s annual meeting in New Orleans, Avandia does not provide any statistically significant reduction in the buildup of plaque in coronary arteries when compared to an older generic diabetes drug.

The findings could add further support to the growing movement calling for an Avandia recall, since many experts indicate that any potential benefits of the drug are outweighed by the risk, especially considering alternative medications that are available.

GlaxoSmithKline PLC’s Avandia (rosiglitazone) was approved by the FDA in 1999 for the treatment of type 2 diabetes. Sales for the drug were over $2 billion a year, until a study published in the New England Journal of Medicine in May 2007 suggested that users of the drug may face an increased risk of heart problems.

The consumer advocacy group Public Citizen, filed a petition with the FDA on October 30, 2008, calling for an Avandia ban.

The group pointed to the previously identified side effects of Avandia which could increase the risk of heart attacks, congestive heart failure, macular edema and bone fractures. However, the group also identified a potential new health concern, pointing to 14 reports of liver failure involving Avandia received by the FDA, 12 of which resulted in death.

Last month, the American Diabetes Association and their European counterpart issued a revised consensus statement on type 2 diabetes treatments, indicating that Avandia should not be used.

The latest research reported on November 12, 2008, has several experts renewing their concerns about the continued use of the Avandia, since there are more effective and safer medications available.

The study involved data on 672 people in 19 countries, testing Avandia against Pfizer Inc.’s Glucotrol, which is also available as generic glipizide. The study was designed to measure plaque buildup in heart arteries, which was measured at the start of the study and 18 months later.

Researchers found that Avandia only provided a slight reduction in placque when compared with glipizide, and the difference was too small to be statistically significant, which means it could have been attributed to chance.