Replies to post #120808 on Biotech Values

[iwfal]

But there is the confounding Arbiter 6-HALTS trial where Niaspan plus statin was shown to be superior (based on CIMT) to Zetia plus statin

It was also stat sig on the pre-defined MACE endpoint. And ARBITER-2, a smaller trial, also showed the same size of efficacy in MACE but was not stat sig because of the smaller number of events.

Finally, of course, there is the HATS trial which was a randomized trial of simvastatin plus niacin vs placebo and was stat sig for the pre-defined MACE endpoint. Of course for this trial the niacin was combined with a statin - but the MACE improvement was very meaningfully better than that expected with moderate dose simvastatin.

Of course for all of these the MACE endpoints were not THE primary endpoint. But they all showed similar efficacy numbers.

That said, there have been a whole bunch of other randomized trials with +/- niacin and none have published MACE rates (but OTOH all were either small or of limited duration - longest being, I believe, a little over a year).

It will be interesting to see the post hoc analyses to understand possible interactions with other drugs or baseline conditions - and then compare that with the results of the other, currently on-going, niacin trial. I think it a reasonable bet there is some interesting and very strong interaction seen across both trials.

PS I've never believed it very likely that niacin's efficacy, assuming there is any, is through HDL.