The primary outcome measure of BETonMACE is simply to determine if there is a statistically significant difference between apabetalone and placebo groups for time to first occurrence of adjudication-confirmed narrowly defined MACE. There is no requirement to meet any arbitrary relative risk reduction mark in order to claim success in meeting the primary outcome. A 30% or greater RRR in 3-point MACE would be great! But a RRR of less than 30% is also a success if statistically significant. Regardless of whether BETonMACE achieves a RRR above or below the 30% RRR, it is extremely important for BETonMACE to achieve statistical significance to be able to claim positive top-line results of meeting its primary endpoint/oucome.

In most recent cardiovascular outcomes trials, the first top-line data news release is simply whether or not the primary endpoint/outcome is acheived. These top-line data news releases can also indicate whether the secondary endpoints/outcomes were achieved. So we likely won't know that actual RRR or any of the detailed data for any of the primary/secondary outcomes until a while after top-line data release. Usually companies present the full detailed data at a big cardio or diabetes conference such as ACC, AHA, ESC, EASD, ADA, etc.

BDAZ