Long-awaited trial offers good Avandia news

Avandia, vindicated? A major company-funded study says yes--at least to a point. According to data presented at the American Diabetes Association's annual meeting over the weekend, the GlaxoSmithKline diabetes drug doesn't increase the overall risk of cardiovascular problems. It does, however, double the risk of heart failure.

Avandia gained a red flag two years ago when cardiologist Steve Nissen concluded [1] that patients using the drug had a 43 percent higher risk of heart attacks. Nissen's meta-analysis of trial data triggered a fierce debate over the Glaxo med and its sister drug Actos, made by Japanese drugmaker Takeda. Avandia got a "black box" warning, the Veterans Administration limited its use, and overall sales dropped precipitously, with Glaxo protesting its safety all the way along.

Enter the new trial, known as Record. The 4,447-patient study--which lasted more than five years--compared Avandia to older drugs metformin and sulfonylurea, showing that its risk profile wasn't so different from other diabetes drugs. Glaxo now plans to submit the data to FDA in hopes of dampening the warning language on Avandia's label. The big question will be whether docs return to Avandia in droves. Any guesses?

- read the Reuters news [2]

Related Articles:
GlaxoSmithKline emails reveal Avandia concerns [3]
Avandia, Actos double fracture risk [4]
Study: Avandia linked to higher death risk [5]
FDA asked to pull Glaxo's Avandia [6]
Nissen questions approval process for diabetes drugs [1]