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Message: Re: What would a successful BETonMACE Top-Line Data Announcement Look Like?
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Aug 10, 2019 10:09PM

"Would RVX be able to state that they met the endpoint come September with only achieving statistical significance in 2 out of 3 cardiovascular events in the BETonMACE?"

I'm going to assume that Resverlogix would not reveal this info in the top-line data announcement and reserve this info for full data. However, I suppose that it is possible for Resverlogix to reveal the additional tid-bits of info you stated in the top-line data announcement. 

Out of the three composite 3-point MACE events (cardiovascular death, non-fatal MI, non-fatal stroke), it is the effects on cardiovascular death that will likely elicit the biggest splash. Effects on non-fatal MI and non-fatal stroke are great too, but if apbetalone only reduces non-fatal MI and/or non-fatal stroke, without reducing cardiovascular death, then this would be viewed very differently than if apabetalone reduced 2 or 3 of the composite 3-point MACE events including cardiovascular death. 

In addition to the primary composite 3-point MACE endpoint, there are several secondary and exploratory endpoints. I've highlighted a few based on your inquiry above.

From the BETonMACE design and rational paper:

"Key secondary end points, evaluated in hierarchical sequence, include time to first occurrence of the composite of the primary endpoint plus hospitalization for unstable angina or a non-elective coronary revascularization procedure, cardiovascular death or non-fatal myocardial infarction, the individual components of the primary endpoint, all cause death, and incidence of hospitalization for congestive heart failure. Other secondary endpoints include changes within and between treatment groups over time in lipids and apolipoproteins A1 and B, fasting plasma glucose, hemoglobin A1c, alkaline phosphatase, and estimated glomerular filtration rate (eGFR) among the subset with baseline eGFR less than 60 ml/min/1.73 m2. Exploratory endpoints include changes within and between groups in plasma high sensitivity C-reactive protein and inflammatory cytokines, RNA profile in leukocytes, health-related quality of life assessed with the EQ-5D-5L and cognitive function assessed with the MoCA."

BearDownAZ

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