Re: What are the biggest hints that BETonMACE will be a huge success,..

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BearDownAZ

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Re: What are the biggest hints that BETonMACE will be a huge success,..

in response to

What are the biggest hints that BETonMACE will be a huge success,..

Cabel

posted on Oct 02, 2018 01:12PM

Cabel,

There is so much available pre-clinical and clinical data detailing apabetalone's beneficial cardiometabolic effects. Check out the published papers and abstracts to refresh your memory.

The biggest risk in my opinion is that the post-hoc analyses of ASSERT, SUSTAIN and ASSURE that gave rise to the impressive 5-point MACE %RRR are mainly based upon "soft" MACE events. Very few of the "hard" 3-point MACE (cardio death, non-fatal MI, non-fatal stroke) occurred in those trials. 3-point MACE is the primary outcome of BETonMACE. Will 5-point MACE post-hoc analyses translate to significant 3-point MACE differences in BETonMACE? That's the multi-billion dollar question.

I don't have access to the more recent post-hoc that included ASSERT (https://www.ncbi.nlm.nih.gov/pubmed/29027131), but the Atherosclerosis 2016 article (https://www.ncbi.nlm.nih.gov/pubmed/26868508) on SUSTAIN/ASSURE details the MACE distribution in Table 2.