I think the only resource that I've seen that breaks down the rosuvastatin vs. atorvastatin MACE event rates (and also by HDL level) is in Fig 6 and Fig 7 of the patent "COMPOSITIONS AND THERAPEUTIC METHODS FOR ACCELERATED PLAQUE REGRESSION." See link below. Keep in mind that this is 5-point MACE data and not 3-point MACE data, that there were very few 3-point MACE events in the post-hoc analysis of SUSTAIN/ASSURE, and these patent graphs show diabetic and non-diabetic patients combined, whereas BETonMACE only has diabetics.
There may be some hints in those patent figures that the rosuvastatin and apabetalone works better to reduce MACE than atorvastatin and apabetalone; however, there is not enough data to conclude this unequivocally, in my opinion. Surely, for plaque reduction rosuvastatin and apabetalone worked better than atorvastatin and apabetalone. But the beneficial effects of apabetalone extend beyond just plaque reduction. So the jury is still out as to whether there will be a difference between the two statin types on 3-point MACE readout.
Resverlogix and members of the BETonMACE Clinical Steering Committee have previously indicated that rosuvastatin vs. atorvastatin is a pre-specified subgroup analysis of the primary endpoint (
see here for other pre-specified subgroup analyses). I was hoping to officially read about these pre-specified analyses in the BETonMACE rationale and design paper, but these were not mentioned. I was also hoping to read in that trial design paper some discussion of the rosuvastatin/apabetalone synergy on plaque regression, but there was no mention.
It will be a much easier path to drug approval for apabetalone if BETonMACE meets the primary endpoint for the mixed statin population, regardless of whether the MACE reduction is more robust in combo with rosuvastatin. Failing to meet the primary endpoint for the mixed statin population and only achieving appreciable MACE reduction in combo with rosuvastatin would have a much bumpier road ahead for drug approval. The subgroup analyses for BETonMACE primary endpoint might even be considered invalid if the primary endpoint is not met for the mixed statin population. Novartis recently encountered a lot of challenges in their failed attempt to get canakinumab approved for cardio indication based on subgroup analysis. All just my opinion.
BearDownAZ
