Bear in reference to your post of Feb 20, 2019, in particular, in the below paragraph, would it surprise you if the BETonMACE trial finds different results that meet or better the goal set by ASSURE of a 0.6% reduction in (PAV), seeing that the BETonMACE trials include the following in the "Secondary Outcome Measures" and the fact that BETonMACE trial is a much bigger trial than ASSURE?
- Percent change in apoA-I concentration over time within and between treatment groups [ Time Frame: 120 weeks ]
- Percent change in apoB concentration over time within and between treatment groups [ Time Frame: 120 weeks ]
- Percent change in LDL-C concentration over time within and between treatment groups [ Time Frame: 120 weeks ]
- Percent change in HDL-C concentration over time within and between treatment groups [ Time Frame: 120 weeks ]
"As for the comments on ASSURE plaque regression from Tada and Koo, the observation of the responder population for plaque reduction was a post-hoc analysis (not pre-specified) of a Phase 2 trial that failed to achieve its pre-specified primary outcome. So although post-hoc data would suggest plaque reduction as a mechanism, this could not be used for product labeling or marketing without a follow up clinical trial to prove via a pre-specified outcome analysis that apabetalone reduces plaque volume. Yes, for the total population the 0.40% reduction in percent atheroma volume (PAV) in the apabetalone group versus baseline failed to achieved statistical significance (p=0.08) or meet the goal of a 0.6% reduction. More concerning in ASSURE was the fact that the placebo group (0.30% reduction in PAV versus baseline, p=0.26) nearly had the same benefit as the apabetalone group. The between group difference in PAV was P=0.81. Similar result for total atherome volume (TAV), as you can read in this ASSURE abstract. So even IF the within group change in PAV from baseline (primary outcome) had achieved statistical significance, there is the elephant in the room that apabetalone had pretty much zero benefit when compared to placebo! This unexpected placebo response is another reason why I urge caution to assuming too much about the expected BETonMACE placebo MACE event rate based upon prior trials such as EXAMINE and ELIXA. "
Just curiousKoo
