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Cited by 176Lipoproteins and Cardiovascular HealthAcute Myocardial Infarction ResearchAtherosclerosis and Cardiovascular Diseases

Rationale and design of the Further cardiovascular OUtcomes Research with PCSK9 Inhibition in subjects with Elevated Risk trial

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Sabatine, Marc S., Giugliano, Robert P., Keech, Anthony, Honarpour, Narimon, Wang, Huei, Liu, Thomas, Wasserman, Scott M., Scott, Robert +2 more·2016·American Heart Journal
DOI 10.1016/j.ahj.2015.11.015
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Abstract

Background Despite current therapies, patients with vascular disease remain at high risk for major adverse cardiovascular events. Low-density lipoprotein cholesterol is a well-established modifiable cardiovascular risk factor. Evolocumab is a fully human monoclonal antibody inhibitor of proprotein convertase subtilisin/kexin type 9 that reduces low-density lipoprotein cholesterol by approximately 60% across various populations. Study design FOURIER is a randomized, placebo-controlled, double-blind, parallel-group, multinational trial testing the hypothesis that adding evolocumab to statin therapy will reduce the incidence of major adverse cardiovascular events in patients with clinically evident vascular disease. The study population consists of 27,564 patients who have had a myocardial infarction (MI), an ischemic stroke, or symptomatic peripheral artery disease and have a low-density lipoprotein ≥70 mg/dL or a non-high-density lipoprotein cholesterol ≥100 mg/dL on an optimized statin regimen. Patients were randomized in a 1:1 ratio to receive either evolocumab (either 140 mg subcutaneously every 2 weeks or 420 mg subcutaneously every month, according to patient preference) or matching placebo injections. The primary end point is major cardiovascular events defined as the composite of cardiovascular death, MI, stroke, hospitalization for unstable angina, or coronary revascularization. The key secondary end point is the composite of cardiovascular death, MI, or stroke. The trial is planned to continue until at least 1,630 patients experience the secondary end point, thereby providing 90% power to detect a relative reduction of ≥15% in this end point. Conclusions FOURIER will determine whether the addition of evolocumab to statin therapy reduces cardiovascular morbidity and mortality in patients with vascular disease.

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  • The size of the patient population was based on the key secondary end point, and 1630 such end-point events were required to provide 90% power to detect a 15% relative risk reduction with evolocumab as compared with placebo.

    “The size of the patient population in the trial was based on the key secondary end point, and we estimated that 1630 such end-point events were required to provide 90% power to detect a 15% relative risk reduction with evolocumab as compared with placebo.11”

    From Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease (2017) · cites this paper as [11]

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Authors
Sabatine, M. S., Giugliano, R. P., Keech, A., Honarpour, N., Wang, H., Liu, T., Wasserman, S. M., Scott, R., Sever, P. S., & Pedersen, T. R.
Affiliations
  • Brigham and Women's Hospital (US)
  • The University of Sydney (AU)
  • Amgen (United States) (US)
  • Imperial College London (GB)
  • Oslo University Hospital (NO)
Corresponding author
Sabatine, Marc S.
ORCID
Venue
American Heart Journal
Publisher
Elsevier BV
Published
2016-03
Volume
173
Pages
94-101
ISSN
0002-8703 (ISSN-L)
DOI
10.1016/j.ahj.2015.11.015
OpenAlex
W2210694332
Cited by
176
References
12
Citations by year
2026: 2 · 2025: 3 · 2024: 6 · 2023: 6 · 2022: 15 · 2021: 14 · 2020: 13 · 2019: 14 · 2018: 19 · 2017: 52 · 2016: 30 · 2014: 1
FWCI
34.02
Type
journal article
Language
en
Open access
Licence
Locations
  • American Heart Journal (publishedVersion)
  • PubMed (publishedVersion)
  • Spiral (Imperial College London) (submittedVersion, cc-by-nc-nd)
Funders
National Institute for Health and Care Research (NF-SI-0513-10059)
Topics
  • Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Acute Myocardial Infarction Research
  • Life Sciences › Immunology and Microbiology › Immunology › Atherosclerosis and Cardiovascular Diseases
Keywords
evolocumab, PCSK9 inhibition, FOURIER trial, major adverse cardiovascular events, LDL cholesterol lowering, statin therapy, myocardial infarction, ischemic stroke, peripheral arterial disease, cardiovascular mortality, cardiovascular morbidity
MeSH terms
Proprotein Convertase 9, Antibodies, Monoclonal, Australia, Cardiovascular Diseases, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Drug Therapy, Combination, Female, United Kingdom, Humans, Injections, Subcutaneous, Lipoproteins, LDL, Male, Norway, Risk Factors, Serine Endopeptidases, United States, Cholesterol, VLDL, Incidence, Survival Rate, Treatment Outcome, Risk Assessment, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Proprotein Convertases, Antibodies, Monoclonal, Humanized

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