Hartland,

After the initial BETonMACE study design was revealed, it was clear that both atorvastatin (lipitor) and rosuvatatin (crestor) were being included despite the ASSURE post-hoc analysis strongly suggesting synergy with rosuvastatin. I recall Don mentioning that the clinical steering committee or others that were consulted with in the design of BETonMACE encouraged both statins to be included. Furthermore, I asked Sarah back in October whether there a pre-defined comparison between those patients on rosuvastatin vs. atorvastatin in BETonMACE and she confirmed that there is. So BETonMACE should officially determine if there is any synergy with one statin vs. another, at least for MACE outcome.

As for your other questions, I broke this down in the past here. The MACE obersvations were based on very limited number of observations in the total population of SUSTAIN/ASSURE. SUSTAIN/ASSURE were never powered for MACE. Whether this is the reason for the FDA not being involved yet is only conjecture. With already low numbers of MACE observations in the post-hoc analysis of the combined statin groups, to further separate them by statin type would kill the statistics so it is a futile exercise at this point. They separated by statin type for the plaque volume measurements because all patients in ASSURE had IVUS testing. Not all patients had MACE of course!

BearDownAZ