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: