Koo wrote: "KBC Amarin was a 5 point MACE and it passed with flying colours if I'm not mistaken."

George wrote: "Let's phrase it like that: Past 5 point MACE data in diabetics in past trials makes me think 3 point MACE is going to be a success."

Amarin's REDUCE-IT trial enrolled over 8000 patients with a median dosing period of almost 5 years and tallied 1600 5-point MACE events, of which ~1050 were 3-point MACE events. That's a lot of observations. Amarin achieved greater than 25% RRR both both 3-point and 5-point MACE with Vascapa in REDUCE-IT.

I've broken down the ASSURE/SUSTAIN post-hoc analyses of MACE events before in this old post. These are based on 499 total patients between the two trials, of which 192 were diabetics. Patients were dosed for ~6 months in both trials. There were only 35 and 14 5-point MACE events observed in the total and diabetic populations, respectively, in the combined ASSURE/SUSTAIN data set. Of the 35 5-point MACE in the total population, only 8 were 3-point MACE (4 deaths, 4 MI). Of the 14 5-point MACE in the diabetic population, only 3 were 3-point MACE (2 deaths, 1 MI). You can see the breakdown for the total population in the Atherosclerosis 2016 publication too. The diabetic patient data is from my notes from a past presentation.

The point that I hope you appreciate is that the post-hoc analysis of ASSURE/SUSTAIN is based on quite limited observations for 5-point MACE and even a smaller number for 3-point MACE. With limited observations, especially for 3-point MACE, reproducibility becomes a concern. 

BearDownAZ