RE:RE:RE:RE:RE:Biggest news EverLifeGoesOn1973,
Although EXAMINE is a good model (diabetic, recent ACS, 3-point MACE), it is only one trial (median 45 days from ACS event to randomization). Two other trials ELIXA and ALECARDIO also followed diabetic recent ACS patients. ELIXA (mean 72 days from ACS to randomization) and ALECARDIO (median 28 days from ACS event to randomization). BETonMACE was listed as having a median time of 34 days from ACS event to randomization in the AHA 2018 poster. BETonMACE also has low-HDL requirement.
Placebo event rates for EXAMINE and ELIXA looks fairly similar at 18 and 24 months. Not exact, but pretty similar. However, ALECARDIO, despite its shorter ACS to randomization time, appears to have lower event rates than EXAMINE and ELIXA. So the take home message is that there is a bit of uncertaintly in predicting the ACTUAL placebo event rate in BETonMACE. Will BETonMACE placebo behave more like EXAMINE/ELIXA, or more like ALECARDIO? Because of this uncertainty, extrapolating to placebo vs. apabetalone events in BETonMACE carries a good deal of uncertainty too. For any given number of patient years, events per 100 patient years, or event rate at a given median dosing period, one could both paint a rosy picture with amazing apbetalone %RRR predictions, or a meh picture with little to no effect of apabetalone.
https://jamanetwork.com/journals/jama/fullarticle/1854356
https://www.nejm.org/doi/full/10.1056/NEJMoa1305889
https://www.nejm.org/doi/full/10.1056/NEJMoa1509225