posted on
May 07, 2016 08:57PM

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Message: Mace
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No formal 3-point MACE post-hoc has been announced, but for good reason. The study was never powered for 3-point MACE (death, myocardial infarction, non-fatal stroke). Only 5 3-point MACE events occured in the 331 RVX-208 patients (1 death, 4 myocardial infarction) and only 3 3-point MACE events occured in the 168 pacebo patients (3 death). Stroke was either not reported or not recorded since it doesn't appear in the list of events. Here is the incidence of MACE in the ASSURE and SUSTAIN Phase 2 Trials from their Atherosclerosis 2016 paper.
RVX-208 (n=331 patients) Placebo (n=168 patients)
Cardiovascular Events MACE n (%): RVX-208 18 (5.4); Placebo 17 (10.1)
Death n (%): RVX-208 1 (0.3); Placebo 3 (1.8)
Myocardial infarction n (%): RVX-208 4 (1.2); Placebo 0 (0.0)
Coronary revascularization n (%): RVX-208 9 (2.7); Placebo 7 (4.2)
Hospitalization for unstable angina or heart failure n (%): RVX-208 4 (1.2; Placebo) 7 (4.2)
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