Repatha® Outcomes Study (FOURIER): Main results
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REPATHA®
APPROVED TO
REDUCE
CARDIOVASCULAR
RISK1

Repatha® Outcomes Study (FOURIER): Main results

Repatha® delivered significant CV risk reductions in subjects with established atherosclerotic CV disease.2
  • Repatha® significantly reduced the risk of the primary endpoint by 15% vs placebo2
    –9.8% with Repatha® vs 11.3% with placebo (absolute risk reduction: 1.5%); hazard ratio: 0.85 (95% CI: 0.79–0.92; p<0.001)2
  • Repatha® significantly reduced the risk of the key secondary endpoint by 20% vs placebo2
    –5.9% with Repatha® vs 7.4% with placebo (absolute risk reduction: 1.5%); hazard ratio: 0.80 (95% CI: 0.73–0.88, p<0.001)2

Cumulative event rates for the key secondary endpoint: Composite of CV death, MI, or stroke2

Individual endpoints2

*Given the hierarchical nature of the statistical testing, the p-values for the primary and key secondary endpoints should be considered significant, whereas all other p-values are nominal.
The treatment effect on stroke was driven by a reduction in risk of ischaemic stroke; there was no effect on haemorrhagic or undetermined stroke.
Assessment of time to hospitalisation for UA was ad-hoc.
§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; CI = Confidence interval; 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; FOURIER = Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk; HR = Hazard ratio; LDL-C = Low-density lipoprotein cholesterol; MI = Myocardial infarction; PCSK9 = Protein convertase subtilisin/ kexin type 9; RRR = Relative risk reduction; UA = Unstable angina.
  1. Repatha® (evolocumab) Summary of Product Characteristics. Last revised: April 2020.
  2. Sabatine MS, et al. N Engl J Med. 2017;376:1713-22.
  3. Gencer B, et al. JAMA Cardiol. 2020; Online first. doi:10.1001/jamacardio.2020.0882.

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