RE:EventsThis "simple" question has come up over and over again on various forums. Short answer is no.
Long answer. Too many unknown variables. BETonMACE modeled after patient population in the EXAMINE trial with the DPP4 inhibitor alogliptin (
NEJM article) in which diabetic patients with recent ACS were tested. EXAMINE was run 2009-2013. The drug failed to reduce 3-point MACE. Both groups had 3-point MACE event rates around 7.5-7.9 events per 100 patient years. One unknown is that we can't assume that the baseline patient characteristics and placebo event rate will be the same between BETonMACE and EXAMINE. Additionally, BETonMACE has a low-HDL requirement that EXAMINE did not. So it could be that BETonMACE patients have an even higher baseline/placebo risk than patients in EXAMINE.
The only "official" update on event rate was first stated in the Feb 2018 BIO CEO slide 15: "
Projected primary MACE rate still 8.0 per 100 patient years on top of aggressive standard of care = strong unmet need." Upon request for clarification, Clayton replied that "
these numbers are derived from all patients" meaning that this is the blinded data that includes apabetalone and placebo. In June,
Tundup posted that "
The rate of MACE events has been dropping steadily since the beginning of the trial, starting off at the expected 8% per 100 patient years but now down to 7.2% per 100 patient years" but that came second hand from Tundup and not officially from a company communication. Either way, for a given event rate, there are multiple ways the placebo/apabetalone split could occur to get that same number. Let's go with 8% overall event rate for combined placebo and apabetalone groups. To get 8% overall event rate, it could be a 11% to 5% split, 10% to 6% split, 9% to 7% split, or no effect with an 8% to 8% split.
"
Can an inference be drawn from the Gross data?" No
BearDownAZ