Re: "57% relative risk reduction of MACE in patients with diabetes mellitus (DM) and CVD..."
posted on
Aug 14, 2018 09:21AM
"I thought Apabetalone reduced MACE by 77% in the phase II post hoc analysis, not 57%....Is this difference simply the difference between 3 and 5 point MACE?"
I knew you or someone else would point that out!
Yes, the original post-hoc analysis of Phase 2 SUSTAIN and ASSURE that was news released and presented at ESC 2014 found 77% RRR in the MACE occurence in diabetics.
A more recent post-hoc analysis was published earlier this year by Stephen Nicholls, Kausik Ray and company.
This post-hoc not only included Phase 2 SUSTAIN and ASSURE, but also Phase 2 ASSERT. In this particular post-hoc analysis, they found:
"Patients treated with apabetalone experienced fewer major adverse cardiovascular events than those treated with placebo (5.9 vs. 10.4%; P = 0.02), a finding that was more prominent in patients with diabetes (5.4 vs. 12.7%; P = 0.02), with baseline HDL-C < 39 mg/dl (5.5 vs. 12.8%; P = 0.01), or with elevated hsCRP levels (5.4 vs. 14.2%; P = 0.02)."
5.4 vs. 12.7 gives the 57% RRR. So the addition of the ASSERT patients is the primary difference. However, there may have been some patients that were included or excluded from the previous post-hoc that were not in the more recent one to due to different criteria. The original post-hoc was based upon the 5-point MACE. This more recent one doesn't state that stroke was included. The abstract states "The incidence of major adverse cardiovascular events (death, myocardial infarction, coronary revascularization, hospitalization for cardiovascular causes) in the treatment groups was evaluated." I don't have access to the paper so I can't tell for sure, but I am pretty sure that no strokes were observed in SUSTAIN or ASSURE, so it should be a non-issue. Both post-hocs likely evaluating the same battery of events.
BearDownAZ