Some think that the overall P value revealed was much worse than a near miss, however as Bear points out we do have P value of P=0.06; it was overall a near miss.  Unfortunately, academia says a miss is a negative trial so the conference reacted appropriately with caution statements and little outward enthusiasm. 

For those who wondered why GFR <60 mattered; here’s why:  when you get to a value > 60 you’re in CKD2, but still quite reasonable, common, we don’t worry too much. GFR <60 is  a transition stage, CKD 3, and this is where  function is trending down, caution.  Anywhere approaching or under 30 and we consider avoiding cardiac caths (avoid the contrast dye) , and adjusting or even taking away important medications for heart failure and cardiomyopathy (ACE/ARB/NI’s) to spare kidney function. Now we have heart patients, not able to take certain standard of care medications, or undergo procedures because of their kidneys.

Stages of chronic Kidney Disease (CKD):

Stage 1 CKD: eGFR 90 or Greater.

Stage 2 CKD: eGFR Between 60 and 89.

Stage 3 CKD: eGFR Between 30 and 59.

Stage 4 CKD: eGFR Between 15 and 29.

Stage 5 CKD: eGFR Less than 15.

So,  It’s the diabetic patient, turned cardiac patient as the heart arteries are ravaged by diabetes, who also becomes a worsening CKD patient, again because the disease ravages the kidneys, who ultimately NEEDS a promising drug that prevents MACE, and spares the kidneys, continuing on a typical medication regimen.  That’s what attracted me to apabetalone; if it works, it checks all the boxes.

 So if Don can pull out some data that shows eGFR actually improved  in a low GFR population, and prevented MACE for that same population, that could be exciting in the shorter term.  While this overall near miss is still very promising in the longer term.   But like most of you, I’ve been in it a few years, I’m long, and really hoping for a hailmary Monday… Bring on those fireworks... great data, BP, bring it all.