Welcome to the Agoracom hub Lost_Soul. 

"Is the report correct when it says that the Phase 3 is related to patients with Type 2 Diabetes only?"

Yes, BETonMACE is only recruiting patients with type 2 diabetes and low-HDL with a recent ACS event.

"Would the Makalu report not be correct in stating "The trials will be considered a success if the endpoint improves on MACE incidence by 25%. Earlier Phase 2 trials showed far higher efficacy at over 40% relative risk reduction.""

The Makalu report is not correct. The most important thing is to achieve statistical significance in the primary outcome of relative risk reduction in 3-point MACE. After than, they are able to validly analyze the individual MACE components as well as validly do sub-group analyses (I'm not 100% sure sub-group analyses are valid if the primary outcome is missed in the entire population), which may provide even more eye-popping numbers. As I stated in my earlier post:

First, the %RRR isn't as important as the statistics. A 25% RRR in 3-point MACE would be unprecedented in modern cardiovascular medicine (Amarin's recent 25% RRR was in 5-point MACE and full data isn't out until Nov 10th). If BETonMACE achieves a 25% RRR in 3-point MACE that meets that statistical threshhold, then this is a blockbuster. Second, keep in mind that the 3-point MACE composite doesn't tell the whole story. If the 3-point MACE metric achieves statistical significance, one needs to then look at what is driving it: CVD death, non-fatal MI, non-fatal stroke, or a combination. Lastly, Makalu is comparing the >40% RRR from 5-point MACE with a 25% RRR in 3-point MACE. Not a fair comparison.

BDAZ