It's far from the first study to address Avandia safety, but it's by far the largest to date, says FDA researcher and study leader David J. Graham, MD, MPH.
The study analyzes Medicare records for 227,571 patients who started treatment with Avandia or Actos between July 2006 and June 2009. The average age of patients in the study was 74.4.
"Our study shows very clearly that Avandia is much less safe than Actos in things that really matter -- things that will put you in the hospital or land you in the cemetery," Graham tells WebMD. "If you are a doctor, there is no earthly reason why you should continue to prescribe Avandia. There are safer alternatives."
GlaxoSmithKline, which makes Avandia, points to its analysis of six clinical trials of Avandia.
"Taken together, these trials show that [Avandia] does not increase the overall risk of heart attack, stroke, or death," GSK says in a news release.
That's a case of missing the forest for the trees, says David N. Juurlink, MD, PhD, head of the division of clinical pharmacology at Sunnybrook Health Sciences Center and a scientist at the Institute for Clinical Evaluative Sciences in Toronto, Canada.
"The issue is you have two drugs on the market with identical indications for diabetes, and this increasing body of evidence that one is safer than the other," Juurlink tells WebMD. "Why would a patient want to go on the drug that is less safe and has no advantage?"
In an editorial accompanying the Graham study, Juurlink notes that the American Diabetes Association and its European counterpart have each advised against the use of Avandia.
Switch to Actos?
The Graham study of older people with diabetes finds that, compared to patients taking Actos, patients taking Avandia had:
27% higher risk of stroke
25% higher risk of heart failure
14% higher risk of death
How big a risk is this really? For every 60 older patients who take Avandia instead of Actos for one year, there would be one extra heart attack, heart failure, stroke, or death.
"If you are a patient currently being treated with Avandia, based on the data from our study it would be wise for you to contact your doctor and ask to be switched to a safer alternative," Graham says. "Even if you have been on Avandia for a while and have not had anything bad happen to you, why take those risks? They are completely unnecessary."
Graham is an outspoken safety advocate within the FDA. He stresses that his opinions are his own and not those of the FDA. He and his colleagues researched, wrote, and published the current study themselves. Despite partial funding by the FDA, the federal agency had no role in conducting, designing, or publishing the study.
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