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Message: BETonMACE Enrollment

"I wonder if the company expects a difference between the two subgroups?  If there is a difference how will it affect the FA?"

Shortly after BETonMACE began back in 2015, I emailed a question to Sarah "Is there a pre-defined comparison between those patients on rosuvastatin vs. atorvastatin, or will that comparison be a post-hoc analysis after BETonMACE has ended?" and she responded "yes the rosuvastatin/atorvastatin will be a pre-specified analysis.

So yes, it sound like the company expect a difference between the two sub-groups. Recall, in the original BETonMACE design it was proposed to only compare rosuvastatin (placebo group) to rosuvastatin plus apabetalone. However, after discussions amongst Resverlogix clinical team, the BETonMACE Clinical Steering Committee and the EMA/FDA, it was decided to use both atorvastatin and rosuvastatin. If there is truly a difference, hopefully the study is statistically powered enough to detect this and provide solid clinical proof of rosuvastatin/apabetalone synergy.

How will this affect the futility analysis? Probably no effect on the FA, in my opinion. I believe the FA is based upon likelihood of achieving the primary endpoint/outcome, which doesn't separate out the different statin types. 

BearDownAZ

 

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