'Neutral' study isn't good enough for Avandia

Did a new study support the idea that Avandia helps roto-rooter plaque from arteries--or is GlaxoSmithKline just desperate for some good news on the diabetes drug? Well, here are the bare stats: Avandia patients saw a .21 percent reduction in arterial plaque, while patients on Glucotrol, an older diabetes med, saw a .43 percent increase. Avandia also hit a secondary endpoint on overall volume of arterial plaque. The company said in a statement that it was "encouraged by findings from the [APPROACH] study which demonstrated that treatment with Avandia may stall the progression of coronary atherosclerosis."

But even the lead researcher--and GSK's press release--admit that the results are statistically insignificant. And according to Forbes, two top cardiologists are underwhelmed by the APPROACH results.

Part of the problem is that Actos, Avandia's closest competitor, posted a statistically significant change in plaque when compared with a different older diabetes med Amaryl. Some experts say Amaryl isn't as good for arteries as Glucotrol is, so that's why Actos seemed to perform better on plaque than Avandia did. Others say comparing the two studies is wrongheaded; it's like apples and oranges, even though they used the same arterial-measurement technique. And still others claim that Amaryl is actually better for arteries than Glucotrol, so Actos performed even better compared with Avandia than the bare numbers seem to show.

The bottom line just may be a wash. "I would call this a neutral finding," James Stein, a cardiovascular imaging expert told Forbes. "It doesn't show benefit, it doesn't show hazard, it doesn't tell us anything."

And given Avandia's safety history, neutral isn't good enough. This study was "too small to confirm or refute the safety issues" about the drug, said Dr. Steve Nissen (photo [1]), the cardiologist and researcher whose analysis first raised those issues last May. As you know, Nissen fingered Avandia for an increased risk of heart problems; the FDA later considered pulling the drug off the market, but settled for a label update. Considering those potential risks, Stein said, "It's time to give this drug a rest. There are better, safer alternatives."

- read the GSK release [2]
- check out the article [3] in Forbes
- see the Pharmalot post [4]

Related Articles:
FDA asked to pull Glaxo's Avandia [5]
Docs: Use cheap diabetes meds first [6]
Journal calls for Avandia restrictions [7]
Nissen questions approval process for diabetes drugs [8]
Scottish docs call for Avandia freeze [9]