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Message: Re: 3 point MACE vs 5 point MACE
3
Nov 02, 2018 09:44AM
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Nov 02, 2018 11:18AM

My first post. Have been a lurker here for years but now that the 'game is afoot' thought i would post. But am still a novice and am asking a novice question so please tolerate me.

The Makalu report states "Resverlogix launched its Phase 3 trial (BETonMACE) in October 2015, "Effect of RVX-208 on Time to Major Adverse Cardiovascular Events in High Risk Type 2 Diabetes Mellitus Subjects with Coronary Artery Disease".

Is the report correct when it says that the Phase 3 is related to patients with Type 2 Diabetes only?

Then from a related old post by Bear, "For the 65 diabetic placebo patients, there were 2 deaths (3.1%), 0 MI, and assuming 0 stroke. For the 127 diabetic apabetalone patients, there were 0 death, 1 MI (0.8%), and assuming 0 stroke. The 2 events (2 deaths) in the diabetic placebo group of 65 patients equates to a 3.077% event rate. The 1 event (1 MI) in the diabetic RVX-208 group of 127 patients equates to a 0.7874% event rate. This is a 0.2559 hazard ratio for a RRR of ~74.4%."

Would the Makalu report not be correct in stating "The trials will be considered a success if the endpoint improves on MACE incidence by 25%. Earlier Phase 2 trials showed far higher efficacy at over 40% relative risk reduction."

 

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