Re: The synergy of rosuvastatin (Crestor) with apabetalone
in response to
by
posted on
Oct 06, 2019 08:30AM
Iconoclast, your mind is already made up so not worth my time to argue too much. Everyone's welcome to their opinion and I do sincerely appreciate all of your input on the board. For everyone else, just know that this opinion is based on a number of assumptions/unknowns like placebo & apabetaone event rates, number of patient years, enrollment/dosing issues and discontinuation/dropout rate. I operate mainly on facts to drive my projected range of possibilities. Having too cloudy of an unknown variable makes it extremely difficult to see too far in the crystal ball. That is just me. Others are much more active in talking to management or other contacts and may have additional insights that I am not privy too. This is fine. Just personally, I discount these since they are unsubstantiated/heresay.
Iconoclast could very well be right that the actual BETonMACE placebo event rate was lower than expected. BETonMACE was designed based on a small number of prior trials in this high-risk patient population (mainly EXAMINE, also possibly ELIXA and ALECARDIO). So EXAMINE might have ended up being a poor model that could not be replicated. However, there is not enough information available to have a much lower placebo event rate be the only explanation for the trial taking longer than expected/planned.
Also, keep in mind that one big contributing factor to the median BETonMACE dosing going to 27 months is that the BETonMACE trial protocol was amended mid trial to allow for patients to be dosed beyong 24 months. Most recent ACS patients are at highest risk of experiencing a subsequent MACE event in the first several months of follow up. So the patients for which extended dosing period beyond 24 months would already be in a lower risk windown.
As for standard of care issue that Tada posted, one can read the details in the design poster or publication.
BDAZ