Friday, May 27, 2011

An Interesting (If Derivative) View Of Zetia® -- On Abbott's Niaspan® Outcome


This comes from the keyboard of Marilyn Mann -- a very cogent (but anonymous) regular commenter (some earlier background):

. . . .Here are my thoughts, and this seems relevant to Merck because they have a niacin drug in development.

In ARBITER 6-HALTS, niacin was superior to ezetimibe, when added to a statin, but it was unclear if ezetimibe is harmful, niacin is beneficial, or both. The results in AIM-HIGH, showing no benefit for niacin when added to a statin, make it more likely that the ARBITER 6-HALTS results mean that ezetimibe is harmful. . . .

I've seen other comments -- to suggest that Merck's tredaptive candidate may have a tougher road, now due to the Abbott announcement, this week -- but this is the first suggesting that Zetia® may ultimately be found to be affirmatively harmful.

We'll keep an eye on this.

2 comments:

marilynmann said...

Here's an interview with Steve Nissen, talking about AIM-HIGH

http://www.pbs.org/newshour/bb/health/jan-june11/cholesterol_05-27.html

Anonymous said...

AIM HIGH has major implications for cordaptive. Now that AIM HIGH is out, cordaptive will remain non-approvable in the US, even after HPS2 is completed. The best possible, and hoped for, trial outcome for Merck would be that cordaptive shows a benefit over placebo. But, how would the FDA interpret this when 2 drugs are being studied? Presumably the niacin component would have shown a null effect, if one believes AIM HIGH is truly negative. So, would a positive result in HPS2 suggest the laropiprant is somehow driving the benefit itself? Why take niacin-laropiprant when only laropiprant is useful? Had HPS2 been designed appropriately, including niacin and laropiprant control arms, in addition to a placebo arm, then the trial result would be interpretable. IN OTHER WORDS, a nulle result in AIM HIGH is the worst possible outcome for Merck and renders HPS2 uninterpretable and unlikely to provide sufficient guidance to the FDA to approve the drug.