Key secondary endpoint:
composite of CV death, MI, or stroke1,2

Repatha® Outcomes study key secondary endpoint Repatha® Outcomes study key secondary endpoint

Cumulative incidence (%)

Years

Repatha® was the first PCSK9 inhibitor FDA-approved to reduce CV risk in a wide range of patients with established CVD—including MI, stroke, and PAD1,2

A double-blind, randomized, placebo-controlled, event-driven trial in 27,564 adult patients with established cardiovascular disease and with LDL-C ≥ 70 mg/dL and/or non-HDL ≥ 100 mg/dL despit high- or moderate-intensity statin therapy. Patients received either subcutaneous injections of Repatha (140 mg every 2 weeks or 420 mg once monthly) or placebo. On stable background lipid-lowering therapy, median LDL-C at baseline was 92 mg/dL.

  • Primary composite endpoint of time to CV death, MI, hospitalization for unstable angina, stroke, or coronary revascularization: HR 0.85 (95% Cl, 0.79-0.92; P < 0.0001)1

  • Key secondary composite endpoint of time to CV death, MI, or stroke: HR 0.80 (95% Cl, 0.73-0.88; P < 0.0001)1

  • Relative risk reductions for the primary and secondary composite endpoints were driven by a reduction in the risk of MI: HR 0.73 (95% Cl, 0.65-0.82), stroke: HR 0.79 (95% Cl, 0.66-0.95) and coronary revascularization: HR 0.78 (95% Cl, 0.71-0.86)1

Observed HR for CV death: 1.05 (95% Cl, 0.88-1.25) and hospitalizations due to unstable angina:
0.99 (95% Cl, 0.82-1.18)1

Post-hoc Analysis in Patients With Prior MI

Watch Dr. Seth Baum discuss an exploratory subanalysis that was performed in patients with prior myocardial infarction.

At Week 48, the median LDL-C was 26 mg/dL.1

ARR = absolute risk reduction; CI = confidence interval; CV = cardiovascular; CVD = cardiovascular disease; HR = hazard ratio; LDL‑C = low-density lipoprotein cholesterol; MI = myocardial infarction; PAD = peripheral artery disease; PCSK9 = proprotein convertase subtilisin/kexin type 9; RRR = relative risk reduction.