*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.
- Repatha® (evolocumab) Summary of Product Characteristics. Last revised: April 2020.
- Sabatine MS, et al. Am Heart J. 2016;173:94-101.
- Sabatine MS, et al. N Engl J Med. 2017;376:1713-22.
- Gencer B, et al. JAMA Cardiol. 2020; Online first. doi:10.1001/jamacardio.2020.0882.
