From the Agoracom board
After doing a lot more digging I've come to the conclusion that BETonMACE patient population is AT LEAST as unhealthy as EXAMINE's patient group.
Time to Randomization post ACS is a hugely determinant factor in patient health. A large percentage of patients tend to have a second MACE shortly following their first. You can simply think of this as a vesion of Lindy principle, where something that has been around for awhile is likely to be around awhile longer. Ergo, a patient that hasn't had MACE following 45 days post ACS, is much less likely to have one than a patient who had a MACE 10 days ago.
Time to randomization post ACS was the one discernable difference between the EXAMINE and LIXA patient populations, 46 vs 72. EXAMINE despite having everyother metric as virtually the same as LIXA's was able to record more 3 Point MACE than LIXA did for 4 point MACE.
With that said, BETonMACE is at 34 if I recall correctly. Huge point in BETonMACE's favor.
The other key factor is the incredibly low HDL.
“The relationship between HDL-C cholesterol and cardiovascular risk appears to be linear, continuous, negative and independent of other risk factors such as blood pressure, smoking and BMI. In addition, the inverse relationship between HDL-C and cardiovascular events does not depend on low-density lipoprotein cholesterol (LDL-C) levels”
BETonMACE =33
EXAMINE = 43
Here again we see another massive advantage for BETonMACE. This is of course ignoring other factors like that 18% of the population is above 70, and the high CRP, and ALP markers. Combined I think these factors more than equal out the CKD patient population difference in EXAMINE (29% vs 11%).
Simply put, we can use EXAMINE as a decent proxy for MACE rates in the first year. After that as I indicated in another post, the superior kidney function of BETonMACE patient group should give any surviving patients added longevity when compared with EXAMINE. This is partly why we are seeing the MACE rates fall so rapidly as time goes on. The "Lindy effect" + functioning kidneys and a great drug in Apabetalone. Remember, Apabetalone has proven to be dramatically superior in patients with low HDL.
This trial is incredibly well designed. The Resverlogix team really knocked it out of the park.
With all this in mind, I estimate that we'll see 3 point MACE RRR exceeding 38%, as well as an impressive read through on both CKD and more importantly he almost 400 patient Vascular Dementia cohort. This is going to be without a doubt one of the most important clinical trials of the decade if not the century.
AI
