Re: Could there be another shoe waiting to drop?
in response to
by
posted on
May 19, 2019 10:52PM
"So Bear, I see no reason to assume that side effects are anything serious."
Thanks for sharing that summary from the annual report. I agree, the liver transaminase elevations don't seem like anything serious enough to jeapordize drug approval, patient adherence or commercial potential. I was simply pointing out the past Phase 2 observations of elevated liver transaminases, since a similar magnitude, frequency and transient pattern of transaminase elevation is likely to occur in BETonMACE. If it does, then this will be reported as a hepatic adverse event that occurred more frequently in the apabetalone vs. placebo group once the full outcomes and safety data are reported for BETonMACE. Very likely the knee-jerk reaction from those unfamiliar with the apabetalone story will be to over-react and blow it out of proportion before appreciating that it is mostly a mild (less than 5X the upper limit of normal), infrequent and transient phenomenon.
Similar to ASSURE, there may be a requirement in BETonMACE for patients to discontinue from trial if the transaminase elevations reach a certain threshhold. So in BETonMACE, the percentage of patients discontinuing apabetalone is likely to be higher than percentage of patients discontinuing placebo. I think in ASSURE it was 2 consecutive measurments of >5X the upper limit of normal (ULN) or a single occurence of >8X ULN. I'm trying to describe this as objectively as possible. But as a disclaimer, this is just my opinion and please do your own due diligence.
BearDownAZ