Re: The synergy of rosuvastatin (Crestor) with apabetalone
in response to
by
posted on
Oct 03, 2019 10:46AM
"First, if I recall your calculations, Phase 2 had a combined 300 patient years dosed on RVX208. Only half were on Lipitor. By contrast, Phase 3 has at least 2000 patient year dosed on our drug. In short, itis quite possible that Phase 2 had a small sample problem. So RVX may have jumped the gun on assuming that it was Crestor that really did it...when in fact, it could be spurious correlation."
Yes, the post-hoc of ASSURE was based on smaller population treated for less time than in BETonMACE. Is this synergy reproducible in BETonMACE? Will the synergy manifest for any of the BETonMACE endpoints? All good and fair questions. Recall IVUS plaque measurements not being done in BETonMACE like ASSURE.
"Second if you are assuming a RRR of 30% for Phase 3, then it is statistically nearly impossible for half the dosed population (on Lipitor) to deliver sub par results on any metric...whether it be a bio marker or an independent risk factor."
All we know right now is that the primary endpoint for the combined statin group did not achieve p<0.05. It could be that BETonMACE whiffed on everything. It could be that it doesn't make a lick of difference if they were on atorvastatin or rosuvastatin. It could be that both statins worked equally well with apabetalone and elicited a very impressive %RRR but BETonMACE just missed statistical significance. It could be that the atorvastatin combo didn't work at all but rosuvastatin combo did amazing and the combined analysis was not significant. It could be both combos worked to some degree but rosuvastatin worked better but still missed statistical significance. So many possible. So little information to discount any of these possibilities.
"Therefore I stand by my assumption that Lipitor dosed patients performed in line with Crestor ones. If that is not the case, then the data simply can't be as good as what DM and Dr Wong are broadly hinting."
Not enough information to conclude anything right now. Lots of possibilities on the table.
BearDownAZ