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Repatha® in established atherosclerotic cardiovascular disease

The Repatha® Outomes Study (FOURIER) was a randomised, event-driven, placebo-controlled, double-blind, multinational trial of 27,564 subjects with established atherosclerotic CV disease (i.e., a history of myocardial infarction, non-haemorrhagic stroke or peripheral artery disease).2
  • Study hypothesis:
Adding Repatha® to optimised statin therapy will reduce the incidence of major adverse CV events in patients with clinically evident vascular disease2
  • Primary endpoint:
Composite of CV death, myocardial infarction, stroke, hospitalisation for unstable angina, or coronary revascularisation (“major CV events”)2
  • Key secondary endpoint:
Composite of CV death, myocardial infarction, or stroke (“major adverse CV events”)2

Study design2

Baseline characteristics3

*Major: type 1 or 2, diabetes mellitus, age ≥65 years, MI or non-haemorrhagic stroke within ≤6 months, additional diagnosis of MI or non-haemorrhagic stroke, current daily cigarette smoking, history of symptomatic PAD if eligible by MI or stroke. Minor: history of revascularisation 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 randomisation, most recent hsCRP >2.0 mg/l by central laboratory before randomisation, 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 randomisation, metabolic syndrome.
All patients had one placebo run-in injection to assess tolerability of SC injections. Patients could choose the dosing frequency of Repatha® and elect to switch every 12 weeks. Dose titrations were not permitted.
In the study, 2690 recent MI patients received Repatha®, 2254 of whom achieved LDL-C levels <55 mg/dl.
§25% RRR reported as the key secondary endpoint: composite of cardiovascular death, MI or stroke. HR: 0.75; 95% CI: 0.62-0.91; p=0.003. ARR: 3.2%; 95% CI: 1.2-5.2.
ACS = Acute coronary syndrome; ARR = Absolute risk reduction; CAD = Coronary artery disease; CV = Cardiovascular; D = Day; EAS = European Atherosclerosis Society; ESC = European Society of Cardiology; EVOPACS = EVOlocumab for Early Reduction of LDL-cholesterol Levels in Patients With Acute Coronary Syndromes; FOURIER = Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk; 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 = Protein convertase subtilisin/kexin type 9; Q2W = Every two weeks; QM = Every month; RRR = Relative risk reduction; W = Week.
  1. Repatha® (evolocumab) Summary of Product Characteristics. Last revised: 31 March 2021.
  2. Sabatine MS, et al. Am Heart J. 2016;173:94-101.
  3. Sabatine MS, et al. N Engl J Med. 2017;376:1713-22.
  4. Gencer B, et al. JAMA Cardiol. 2020;5(8):1-6. Main paper & Supplementary appendix.

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