Avandia Study Spurs New Heart Risk Debate
Diabetes Drug Doesn't Raise Risk of Death From Heart Disease, Shows Study; Critics Find Flaws
Home disagrees, and expects the American Diabetes Association committee to give serious consideration to the new findings, which appear in the June 5 early online edition of The Lancet.
In an editorial accompanying the study, Ravi Retnakaran and Bernard Zinman of Toronto's Mt. Sinai Hospital agree with Nissen that the study's open-label design -- and it's much lower-than-expected rate of cardiovascular deaths -- are problematic.
"Definitive conclusions about the relation between [Avandia] and cardiovascular risk remain elusive, owing to study limitations," Retnakaran and Zinman write. "Furthermore, the findings are inconclusive for [heart attack], for which a non-statistically-significant increased risk was noted in the [Avandia] group."
Unfortunately, a definitive answer isn't soon forthcoming. The TIDE trial isn't scheduled to end until October 2015.
Meanwhile, Retnakaran and Zinman suggest that doctors consider prescribing half doses of Avandia, noting that a half dose offers more than half the benefit of a full dose -- and fewer risks.