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Avandia: Less Risky in Younger, Healthier Patients?

Study Finds Avandia No Riskier Than Actos, Unlike 4 Other Studies
WebMD Health News
Reviewed by Laura J. Martin, MD

Aug. 24, 2010 -- A study of patients enrolled in a large HMO finds no evidence that the diabetes drug Avandia is riskier than Actos, a similar medication.

The findings are in striking contrast to four other large studies with similar designs. Data from those studies suggest that Avandia increases risk of heart attack in younger patients and risk of death in older patients.

The new study isn't entirely new. It's an "enhanced version" of data presented to an FDA advisory committee in 2007. Like the earlier version, it finds Avandia is no riskier than Actos, says study author Debra A. Wertz, PharmD, of HealthCore Inc.

"Looking at a composite endpoint of heart attack, acute heart failure, and death, we observed no significant differences between the two agents in our study population," Wertz tells WebMD.

Why did the results differ so markedly from other studies with similar designs?

"All of these studies have different methodologies and different observational data," Wertz says. "Our particular study did look at a commercially insured population that may be healthier and younger than others."

Indeed, a recent study by FDA safety researcher David Graham, MD, and colleagues found that Medicare patients with diabetes were at significantly greater risk of death if they took Avandia rather than Actos. But those patients were all over age 65, with an average age of 74.4.

In the Wertz study, patients' average age was 54. And they were all privately insured, suggesting that even the older patients in the study were more likely to be employed and thus relatively healthy.

Aviandia Study 1 Piece of the Puzzle

Steven Nissen, MD, the Cleveland Clinic cardiologist who was among the first to warn of Avandia's possible heart risks, says the Wertz findings cannot be considered in isolation.

"There is a consistent pattern of excess risk with [Avandia] apparent in multiple observational studies and meta-analyses performed by independent physician-scientists and the FDA," Nissen tells WebMD via email. "The totality of data continue to demonstrate that [Avandia] increases adverse cardiovascular outcomes in comparison to [Actos]."

Even so, Wertz says the new study is important and will be helpful to patients and their doctors in deciding which diabetes treatment is best for them.

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