Re: Question to ask at the AGM
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posted on
Oct 30, 2019 09:36PM
During the AGM and Corporate Update, folks should listen carefully for use of the terms secondary and exploratory endpoints.
From the BETonMACE rationale and design paper, it sounds like the eGFR change is a secondary endpoint but MoCA score change is an exploratory endpoint. So any questions/answers tomorrow regarding the timing of other endpoint results should be phrased in a way to avoid ambiguity. Make sure those questions are explicitly clear to get the most informative and interpretable answer. Thanks in advance for those attending!
"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/1.73m2.
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."
There are a couple of minor differences in the endpoints listed on ClinicalTrials.gov. Secondary also includes fasting insulin and exploratory also includes fibrinogen.
BDAZ