Repatha® Outcomes Study: a multicenter, double-blind, randomized, placebo-controlled trial1-3

Screening

  • Age ≥ 40 to ≤ 85 years

  • Prior MI, prior stroke, or symptomatic PAD

  • Additional risk factors (≥ 1 major or ≥ 2 minor)*

  • Stable background lipid-lowering therapy (including effective dose of statin ± ezetimibe)

  • LDL-C ≥ 70 mg/dL or non–HDL-C ≥ 100 mg/dL

MAX ≈ 15 WEEKS

1:1 randomization to study drug

REPATHA® 140 mg every 2 weeks or
420 mg once a month + statin (n = 13,784)

PLACEBO + statin (n = 13,780)

Day
1

Wk
4

Wk
12

Wk
24

Number of key
secondary endpoints
achieved

Median follow-up duration: 26 months (2.2 years)

Primary endpoint: composite of time to first event of CV death, MI, stroke, hospitalization for unstable angina, or coronary revascularization

Key secondary endpoint: composite of time to first event of CV death, MI, or stroke

The Repatha®
(Evolocumab) CV
Outcomes Trial (FOURIER)

Gain expert insights on the Repatha® CV Outcomes Trial (FOURIER) with Harold E. Bays, MD and Seth J. Baum, MD.

*Major risk factors: type 1 or 2 diabetes mellitus, age ≥ 65 years, MI or stroke within ≤ 6 months, additional diagnosis of MI or stroke, current daily cigarette smoking, history of symptomatic PAD if eligible by MI or stroke. Minor risk factors: history of revascularization not related to MI, residual CAD with ≥ 40% stenosis in ≥ 2 large vessels, most recent HDL-C < 40 mg/dL (1.0 mmol/L) for men and < 50 mg/dL (1.3 mmol/L) for women by central laboratory before randomization, most recent hsCRP > 2.0 mg/L by central laboratory before randomization, most recent LDL-C ≥ 130 mg/dL (3.4 mmol/L) or non–HDL-C ≥ 160 mg/dL (4.1 mmol/L) by central laboratory before randomization, metabolic syndrome.2

99.7% of patients in the Repatha® arm and 99.8% in the placebo arm received moderate- to high-intensity statin therapy.1

CAD = coronary artery disease; CV = cardiovascular; CVD = cardiovascular disease; HDL-C = high-density lipoprotein cholesterol; hsCRP = high‑sensitivity C-reactive protein; LDL-C = low-density lipoprotein cholesterol; MI = myocardial infarction; PAD = peripheral artery disease; PCSK9 = proprotein convertase subtilisin/kexin type 9.