Avandia Raises Risk of Heart Failure, Fractures
June 6 -- FRIDAY, June 5 (HealthDay News) -- The diabetes drug Avandia significantly raises the risk of both heart failure and bone fractures, but it does not boost the odds for either cardiovascular disease or death, new research has found.
If anything, the drug may slightly lower the overall risk of death, said the authors of the much-anticipated RECORD study, which was presented Friday at the American Diabetes Association's annual meeting in New Orleans and published simultaneously online in The Lancet.
"The findings essentially are that, in overall cardiovascular terms, the drug is safe," Dr. Philip D. Home, chairman of the study steering committee and a professor of diabetes medicine at Newcastle University in Britain, said during a Friday news conference. "There's no decreased risk, and that includes the heart failure element. If anything, deaths were reduced with rosiglitazone [Avandia] compared to those in the control group. It doesn't reach statistical significance, but it's on the right side of benefit."
The trial was funded by GlaxoSmithKline, which makes Avandia.
Home stated that the drug "clearly has a role, alongside other drugs [in the treatment of diabetes], provided you obey the contraindications, which are not to use it in people with heart failure and to think twice for people at high risk for fractures."
Dr. Carl J. Lavie, medical director of cardiac rehabilitation at Ochsner Heart and Vascular Institute in New Orleans, said, "This study provides some degree of support that Avandia is probably not adversely affecting cardiovascular health to any major degree."
But Lavie added that many physicians are waiting for the results of another trial, known as TIDE, which compares Avandia with Actos, another drug in the same class. "Until then, I suspect that not much will change -- both drugs are contraindicated in heart failure and I doubt that this trial will lead the societies to change their recommendations that were based on many trials," he said.
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