Could Avandia's safety risks be avoided just by lowering the dose? A new study suggests it. Published in the Lancet, the study tested half doses of Avandia in combination with the commonly used diabetes drug metformin against placebo--and it found that the drug combo cut the risk of developing diabetes by two-thirds. And the patients taking this low-dose cocktail didn't develop the weight gain or heart problems associated with higher Avandia doses, the researchers say.
Of course, more study is needed to confirm that safety-risk news, the Lancet notes. "The side-effect profile for the low-dose combination looks favorable," a commentary accompanying the study asserts. "However, that conclusion is not yet definitive."
Even a suggestion of good news is a positive for Avandia. The drug has been on the decline since May 2007, when a New England Journal of Medicine report linked the GlaxoSmithKline (NYSE: GSK) drug to a 43 percent increased risk of heart attack. Since then, the drug has been slapped with FDA warnings, and GSK has launched a head-to-head safety study with Takeda's rival drug Actos.
Now, that safety study is drawing criticism from medical ethicists and consumer advocates, while the FDA prepares for another advisory panel review of Avandia's risks. Some are calling for Avandia to be withdrawn altogether. If dosing changes can mitigate the possibility of serious side effects, FDA and GSK could have themselves a solution.
- read the Bloomberg piece
- see the piece in the Los Angeles Times