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Message: Re: Clarification on BETonMACE baseline data
5
Sep 05, 2019 06:20AM

Buckeyes wrote "I think it was previously discussed and I am probably being lazy and forgetful .... but was there ever a post hoc 3-point MACE RRR% delineated within the 5-point MACE group (for a 3-point MACE post hoc sub-group) from the previous P2 study?"

Yes, we have discussed this a lot of this forum. See this post. Long story short, there were too few 3-point MACE events amongst the 5-point MACE events to conclude anything.

https://agoracom.com/ir/Resverlogix/forums/discussion/topics/706042-time-to-add-3-vs-5-pt-mace/messages/2189306

"I also recall that it was a "less sick" group overall, may or may not be useful or enlightening for study projection purposes (??), just trying to recall if we had that info & convo previously?"

Two main differences between the Phase 2 post-hocs and BETonMACE. The biggest difference is that BETonMACE requires all patients to have experienced an acute coronary syndrome (ACS) event within 7-90 days of starting in the trial. The other big difference is that BETonMACE requires patients to be all diabetic, whereas the Phase 2s did not. There were enough patients in the combined Phase 2 post-hoc to look at the diabetic subset, but the Phase 2 trials did not require a diabetes inclusion criteria. The BETonMACE patients might also have slightly lower baseline HDL-C than the Phase 2 trials, but I'd have to look back at the Phase 2 trial data to know for sure. But overall, BETonMACE is a much higher risk (sicker) population than in the Phase 2 trials.

BearDownAZ

 

5
Sep 06, 2019 10:51AM
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