Wow 69% AHI reduction in a pill

PST wrote:Something that fuels my skepticism is that the placebo group had a 39 percent reduction in AHI ((44-27)/44). I admit that a 69 percent reduction is better than 39 percent, but that's quite a placebo effect.

That's a very good catch. A quick look at the OB-302 and OB-303 studies that just measured weight loss for this drug show they were deliberately targeted for those with morbid obesity (starting BMI was 42.1 in the first, and 36.3 in the second), which makes sense for a diet drug, and if you dropped below a BMI of 22 you ended up getting dropped from the latter study. The OB-204 study (which is what they used for the apnea trial) doesn't discuss starting BMI save that it ranged in the 30-40 range and that patients refused CPAP treatment prior to it.

The starting BMIs, though, are significant because there've been a couple of peer reviewed articles that suggest those patients whose apnea is positional end up having a significant drop in AHI once they go from morbid to just overweight, because all of a sudden side sleeping begins to work again. That could easily explain a drop in AHI of the levels reported in the study.

Mac33 wrote:Looks like the clinical trials had found a beneficial side effect of preventing tongue and muscle collapse during sleep.

You may be confusing this with the early studies on mirtazapine a few years back, which actually did show some promise before the massive appetite enhancement it causes overwhelmed whatever beneficial effects it had on supporting throat structure. I haven't seen anything whatsoever in the application or results of the trials that suggest this in OB-204. Can you provide a link?

As far as the component drugs, I wouldn't get too excited either way; the whole point of the compound seems to be making a low-dose, extended release version of them, and like many drugs it's more a matter of finding a dosage that works without side effects. May end up being an effective appetite suppressant, but that's a different argument than being helpful for OSA.

Now if they could just figure out a way to bioengineer a compound with estrogen-like effects for OSA without the whole little issue of destroying hormonal balance I'd be a lot more interested, but that actually requires research rather than combining old drugs and new release mechanisms....