Risks of the Drug Avandia (Rosiglitazone)

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Avandia (rosiglitazone) is a commonly used medication to treat type 2 diabetes. In a study published in the New England Journal of Medicine released online yesterday, Dr. Steven E. Nissen and Kathy Wolski from the Cleveland Clinic analyzed 42 previously performed trials of rosiglitazone. They found that the use of this medication was associated with a 42% increase in the risk of myocardial infarction (heart attack) compared with placebo or other medications used to treat diabetes. The authors caution that this data is preliminary and has many limitations, but it does point to the potential for increased cardiovascular risk from rosiglitazone as compared with other medications used to treat diabetes.

Based on this study, the FDA has issued a safety alert for rosiglitazone:
"FDA remains committed to assuring that doctors and patients have the latest information available to make treatment and medication use decisions. In this case, FDA is carefully weighing several complex sources of data, some of which show conflicting results, related to the risk of heart attack and heart-related deaths in patients treated with Avandia," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research. "We will complete our analyses and make the results available as soon as possible. FDA will take the issue of cardiovascular risk associated with Avandia and other drugs in this class to an Advisory Committee as soon as one can be convened."
Rather than removing Avandia from the market, the FDA has decided to further study the data. They caution that patients shouldn't stop Avandia on their own without first speaking with their doctor. They also say that is an open question whether the other medication in the same class as Avandia, Actos (pioglitazone), has the same cardiac risks.

Interestingly, in his paper Dr. Nissan suggests that he believes that Actos may have fewer cardiac risks than Avandia. He points to the PROACTIVE trial, which actually show lower cardiac risks with Actos:
The question as to whether the observed risks of rosiglitazone represent a "class effect" of thiazolidinediones must also be considered. Pioglitazone is a related agent also widely used to treat type 2 diabetes mellitus. However, unlike rosiglitazone, pioglitazone has been studied in a prospective, randomized trial of cardiovascular outcomes, called Prospective Pioglitazone Clinical Trial in Macrovascular Events (PROACTIVE). The primary end point, a broad composite that included coronary and peripheral vascular events, showed a trend toward benefit from pioglitazone (hazard ratio, 0.90; P=0.095). A secondary end point consisting of myocardial infarction, stroke, and death from any cause showed a significant effect favoring pioglitazone (hazard ratio, 0.84; P=0.027). Notably, pioglitazone appears to have more favorable effects on lipids, particularly triglycerides, than does rosiglitazone.
Patients taking Avandia and the physicians caring for them have three choices.
  1. Continue Avandia.
  2. Stop Avandia and use a diabetes medication in a different class instead.
  3. Stop Avandia and substitute Actos, which is the same class of medication but which may be safer.
I predict that many physicians and patients with choose option 3, as long as no significant cardiac risks from Actos are identified.

An interview with Dr. Steven Nissen from the Wall Street Journal is below.



Related Link: Medications to Treat Diabetes
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MD, FACP, FASN

Dr. Schwimmer's blog explores the intersection of medicine, new technologies, and the Internet.

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