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Message: Re: No mention of efficacy again...
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Mar 27, 2019 01:04PM

"Just wondering if maybe the reason that they're no longer mentioning efficacy and only saftety....could it be that at this late stage, that efficacy is no longer a concern, that only safety is needed to be checked?"

In my opinion, the omission of the efficacy statement from the past 2 DSMB reports should not be taken as an indication of the probability of BETonMACE successfully achieving its primary outcome. It is also my opinion that any efficacy statement made by the DSMB is simply attesting whether or not apabetalone is increasing MACE, not whether apabetalone is decreasing MACE. Safety checks likely refer to the incidence of adverse events outside of the primary 3-point MACE outcome; whereas efficacy checks are likely ensuring that apabetalone isn't increasing incidence of cardiovascular death, non-fatal MI and non-fatal stroke. The droppage of the efficacy statement from the last two DSMBs means nothing to me. Resverlogix decided to forego the originally planned futility and sample size re-estimation interim analyses, which were likely the only opportunity to truly allow the DSMB to test for apabetalone's efficacy at decreasing MACE. DSBM would only do these interim tests if Resverlogix and the Clinical Steering Committee asked them to. 

"Its just a thought.....Abucanumab's trials were halted for efficacy, but our last 2 DSMB reccomendations don't mention it after the first 7 did.  Is it possible that efficacy has already been sufficiently established?"

See above. The Biogen/Eisai trials for Aducanumab were halted due to the results of the interim futility analysis. From the Biogen news release "The decision to stop the trials is based on results of a futility analysis conducted by an independent data monitoring committee, which indicated the trials were unlikely to meet their primary endpoint upon completion. The recommendation to stop the studies was not based on safety concerns." Resverlogix and the Clinical Steering Committee decided to not perform the previously planned futility and sample size re-estimation analyses. These would have been the only opportunity for the DSMB to halt BETonMACE for efficacy, in my opinion, other than an obvious reason like apabetalone increasing MACE incidence. So no, I do not think efficacy (decreasing MACE) has been sufficiently established because it has not been tested yet.

BearDownAZ

P.S. Jupiter posted a great reply while I was typing this one.

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