Sorry Jupe. You've exceeded my expertise. Like I warned, I am no biostatistician. In my slightly ignorant opinion, pretty much all MACE event cardiovascular outcomes trials (CVOTs) are treated the same from a statistical standpoint and analyze the data in a time-to-first occurrence format via the Kaplan-Meier analysis. I think the EXAMINE trial description is just written in an odd way. I pulled up the trial descriptions for a bunch of recent CVOTs (FOURIER, ODYSSEY, REDUCE-IT, EMPA-REG OUTCOME, ELIXA, CANVAS, CANTOS, DECLARE-TIMI, PIONEER 6, REWIND, COLCOT) and they are all time based (time to first occurence of event). So BETonMACE is consistent with most if not all CVOTs. EXAMINE may have been treated the same, just written in a weird way.

One difference between some of the recent diabetes CVOTs and BETonMACE is that some of these other drugs (like the SGLT2 inhibitors, DPP4 inhibitors, GLP1-R agonists) were being tested for BOTH non-inferiority and superiority. These were already approved for glucose control, but cardio safety had not been established. So these previous trials were being run to both show that the drug doesn't increase MACE risk (non-inferiority), and to test whether there was a MACE reducing effect (superiority). BETonMACE is only testing for superiority.

BearDownAZ

P.S. Sorry Danceswithhorses :-)