"The FDA will look at this and when they put this together [with the other studies] they will come up with a warning -- be thoughtful about how to prescribe this -- but they will not take it off the market," Garratt predicted.
The study released Monday afternoon was from the Rosiglitazone and Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes (BARI 2D) trial, originally designed not to look at the drug's safety but to determine how best to treat patients with both type 2 diabetes and coronary artery disease, a population at much higher risk of having a heart attack or stroke.
The study was funded by the U.S. National Institutes of Health as well as GlaxoSmithKline, which makes Avandia.
Almost 2,400 patients were randomly chosen to receive either medications plus angioplasty or bypass surgery, or medication alone.
Participants were also assigned to receive a drug to enhance insulin levels (including insulin itself) or drugs to help the body respond more effectively to insulin (either Avandia or metformin). The researchers noted that Avandia was not randomly prescribed but left to the discretion of individual physicians. That could detract from the validity of the findings, since randomized trials are considered the "gold standard" of research.
The researchers looked at 4.5 years of follow-up data. After adjusting for various factors, "the occurrence of death, heart attack and stroke was 28 percent less frequent" for those taking Avandia as compared with those patients not taking a TZD, said Bach.
The incidence of congestive heart failure was higher but this was not considered significant; there was a 45 percent increased risk of fractures, which was considered significant.
However, in one of the two studies published Monday -- a large review of data led
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