RE:Response to PoC regarding post-hoc analysis/MACE RRR, ARRA useful comparison of BETonMACE will be the Jardiance SGLT2 inhibitor EMPA-REG OUTCOME trial, whose results will be revealed at the EASD meeitng mid-September (same meeting the RVX is talking at). Their patients are type 2 diabetics that are also high-risk for CVD (see table I of the paper below for inclusion criteria). BoM will likely have nearly identical inclusion criteria AND require low-HDL (not required for EMPA-REG OUTCOME). In EMPA-REG OUTCOME, "At baseline, 77% of patients were receiving a statin, 9% were receiving a fibrate, 85% were being treated with an acetylsalicylic acid agent, and 94% were receiving any drug for BP reduction (80% on blockers of the renin-angiotensin system)."
It will be very informative to see the incidence rate of MACE in both the control and jardiance treated group to compare to the MACE incidence rate found in the ASSURE/SUSTAIN post-hoc analysis. The relative risk reduction and the absolute risk reduction in the control group vs. jardiance treated group will also be very informative to put the effect size of RVX-208 in perspective. The EMPA-REG OUTCOME trial will give us a good idea of the baseline MACE risk we may expect in the diabetic BoM trial and hopefully either validate or provide a reality check for the post-hoc ASSURE/SUSTAIN numbers.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4072621/
BDAZ