Repatha® Outcomes Study: a multicenter, double-blind, randomized, placebo-controlled trial1,2

Repatha® Outcomes study design Repatha® Outcomes study design

*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; hsCRP = high-sensitivity C-reactive protein; MI = myocardial infarction; PAD = peripheral artery disease; defined as a history of intermittent claudication (with or without supporting vascular investigations) or previous peripheral arterial revascularization procedure, amputation, or aneurysm repair; PCSK9 = proprotein convertase subtilisin/kexin type 9.