Physicians urged to take measured approach in response to potential Avandia risks

May 28 2007

The Endocrine Society urges physicians to respond in a measured way to a recent study suggesting the diabetes drug Avandia (rosiglitazone) increases the risk of heart disease and heart attacks.

In a statement issued, The Endocrine Society stressed to physicians that the results, which were published in the New England Journal of Medicine (NEJM), raise concerns about this drug, but the study is not definitive and has many weaknesses, as pointed out by its authors and the accompanying editorial. The Society also advises healthcare providers to counsel their patients about the findings of the study, discussing their implications on an individual basis, and reviewing the risks and benefits of remaining on rosiglitazone versus changing therapy.

According to the Society's statement: “Switching patients from rosiglitazone [Avandia] to another drug in the same class is not risk-free, both because the NEJM study's findings might represent a class effect and because the impact of any drug substitution can be unpredictable.”

The statement also acknowledged that: “It would also seem prudent, given the very high baseline risk of cardiovascular events in patients with diabetes, to redouble efforts to reduce other cardiovascular risk factors… in those diabetic patients taking medications with postulated cardiovascular side effects.”

The NEJM study, which was a meta-analysis of many preceding studies, cannot determine who is at greatest risk, if there is a relationship between risk and the dose or length of treatment, or if the findings are unique to this drug or to all drugs in its class. It is notable that two studies, one completed and one 4-year study that is on-going , which were specifically designed to address the issue of cardiovascular effects, have not found any negative effect to date.

The full text of the Society's statement can be found here: http://www.endo-society.org/publicpolicy/policy/avandia.cfm

http://www.endo-society.org.