Jonzobot,

Thanks for the info on the FDA considerations of subgroup analysis. 

Your recollection of the pre-specified analyses of the primary 3-point MACE outcome wasn't exactly correct. See below. Additionally, there are the cognition and CKD sub-studies looking at change in MoCA score and eGFR, respectively. 

In the R&D Day Presentation from 10/13/2016, Michael Sweeney had the pre-specified analysis slide described below (I have the slides right in from on me).

Most recently, the same pre-specified analysis slide was presented in the ERA-EDTA presentation by Dr. Kam Kalantar-Zadeh. 

The latter two examples above both state that pre-specified subgroup analyses for the primary endpoint in BETonMACE include those analyses listed below. I also had a post on this in July of last year.

– Rosuvastatin/Atorvastatin

– < 30 days/> 30 days post-acute coronary syndrome

– LDL/HDL/TG’s above and below median

– HbA1c above and below median

– eGFR >60 mL/min and < 60 mL/min

BearDownAZ