BearDownAZ,

I found what you posted here very interesting, where you compared the BETonMACE trial with the EXAMINE trial,.. where all the conditions were the same except for the low HDL that is only in our trial. IN your post 

1) EXAMINE Trial Event 3-point MACE Rate Estimates: Estimates of BETonMACE event rates are estimated from the EXAMINE trial in patients with diabetes and an ACS event within the past 90 days. BETonMACE patients will also be diabetic and recent ACS, but also will have low-HDL (see #2 below). The study drug, Alogliptin, in EXAMINE didn't work to increase or decrease 3-point MACE events, so both placebo and Alogliptin groups behaved more or less the same. The percentage of patients experiencing their first 3-point MACE event was ~11% over the median follow up of 18 months based upon graphs and statements from sources below. Additionally, eye-balling the primary outcome graph, I estimate a percent of: ~13% at 24 months, ~11% at 18 months, ~8% at 12 months, ~5% at 6 months, and ~2.5% at 3 months. So the event rate (first 3-point MACE event/month of follow up) is highest during the first 6 months of the follow up, and then the rate drops a bit in each of the subsequent 6 month periods.

In same post you estimated to add 15% higher MACE event rate because we had lower HDL patients.

In my opinion, I think the added criteria of very-low HDL-C in BETonMACE may increase CVD risk by 15%. However, this is a big unknown. It might have a large, modest or no effect on the event rates modeled by the EXAMIINE trial. For example, if the EXAMINE trial modeled an 11% event rate at 18 months, the very-low HDL-C population in BETonMACE would be (11%) X (1.15) = 12.65%.

I googled Low HDL and it seems to be the cause: In fact, studies have shown that low HDL levels arelinked to an increased risk of developingcardiovascular disease.

My question is: Even if low HLD has no effect on the MACE event rate,.. if we go from 11% down to 7.2% (as of tundup's post back in June 2018),.. is that not a positive indication that our drug is working,...?  Would it not give us a RRR = 34%,..?

Much appreciated!