Long-term data
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Repatha® long-term data

In OSLER-1, the longest clinical trial exposure to a PCSK9 inhibitor to date, Repatha® produced sustained reductions in LDL-C levels over 5 years:*2
  • After 52 weeks, Repatha® plus SOC reduced LDL-C by 59%2
  • After 2, 3, 4, and 5 years of follow-up, LDL-C was reduced by 56%, 57%, 56%, and 56%, respectively, from parent study baseline2

Sustained efficacy and long-term safety of Repatha® in hypercholesterolaemia2

OSLER-1 was a randomised, open-label extension study to assess the long-term safety and efficacy of Repatha® in patients who completed treatment in a “parent” study. During Year 1 of OSLER-1, participants were randomised 2:1 to receive either Repatha® plus standard of care (SOC) or SOC alone. After Year 1, all participants received Repatha® plus SOC.2

*Secondary study objectives characterised yearly changes in lipid levels compared with baseline levels measured before parent study participation.
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; AE = Adverse events; ARR = Absolute risk reduction; CV = Cardiovascular; EAS = European Atherosclerosis Society; ESC = European Society of Cardiology; EVOPACS = EVOlocumab for Early Reduction of LDL-cholesterol Levels in Patients With Acute Coronary Syndromes; LDL-C = Low-density lipoprotein cholesterol; MI = Myocardial infarction; OSLER = Open Label Study of Long Term Evaluation Against LDL-C Trial; PCSK9 = Protein convertase subtilisin/kexin type 9; RRR = Relative risk reduction; SOC = Standard of care.
  1. Repatha® (evolocumab) Summary of Product Characteristics. Last revised: 31 March 2021.
  2. Koren MJ, et al. J Am Coll Cardiol. 2019;74:2132-46.
  3. Gencer B, et al. JAMA Cardiol. 2020;5(8):1-6. Main paper & Supplementary appendix.

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