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Message: time to add/3 vs 5 pt. MACE

Noretreat wrote: "Did the company (oe anyone) ever try to analyze the previous data using 3 point MACE instead of 5?  I can vaguely remember a discussion of that some years back but don't recall seeing any results."

See below.

Tada wrote: "noretreat - Look at slide 9 in the BioEurope PP Presentation in the link library, Nichols et all. Those are the 3pt MACE results. Over 60% RRR however very few subjects."

No. Tada, that is 5-point MACE, not 3-point MACE. See below.

Slide 9 of the March 14, 2018 BioEurope Presentation is citing the Nichols et al paper from 2018. Both slide 9 and the Nichols et al. paper clearly state that they are using 5-point MACE, not 3-point MACE. I broke down the 3-point vs. 5-point MACE event stuff back in an October 2015 post that relied upon an ESC 2014 slide deck. Since then, the Atherosclerosis 2016 paper has been published, which had the same data as the ESC 2014 slide deck. The analysis was done a little bit differently between the Atherosclerosis 2016 and Nichols et al 2018 papers, but the results are close: 44% vs. 55% RRR for the total population, and 57% vs. 77% RRR for the diabetic population, with the Nichols et al 2018 study having the lower number. This is all 5-point MACE!

There were actually very few 3-point MACE events. The following  data in this and the next two paragraphs is from the ESC 2014/Atherosclerosis 2016 data that I summarized back in October 2015. There were a total of 35 5-point MACE events in the total patient population (n=499); 27 of these 35 were the "soft" coronary revascularization/hospitalization for unstable angina or heart failure category. There were a total of 14 5-point MACE events in the diabetic patient population (n=192); 11 of these 14 were the "soft" coronary revascularization /hospitalization for unstable angina or heart failure category.

For the 168 total placebo patients, there were 3 deaths (1.8%), 0 MI, and assuming 0 stroke (nothing reported for stroke). For the 331 total apabetalone patients, there was 1 death (0.3%), 4 MI (1.2%), and assuming 0 stroke. The 3 events (all deaths) in the total placebo group of 168 patients equates to a 1.786% event rate on a 3-point MACE scale. The 5 events (1 death, 4 MI) in the total apabetalone group of 331 patients equates to a 1.511% event rate on a 3-point MACE scale. This is a 0.8459 hazard ratio for a RRR of ~15.4%. 

For the 65 diabetic placebo patients, there were 2 deaths (3.1%), 0 MI, and assuming 0 stroke. For the 127 diabetic apabetalone patients, there were 0 death, 1 MI (0.8%), and assuming 0 stroke. The 2 events (2 deaths) in the diabetic placebo group of 65 patients equates to a 3.077% event rate. The 1 event (1 MI) in the diabetic RVX-208 group of 127 patients equates to a 0.7874% event rate. This is a 0.2559 hazard ratio for a RRR of ~74.4%. 

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