The Evolving Future of PCSK9 Inhibitors

Rosenson, Robert S.; Hegele, Robert A.; Fazio, Sergio; Cannon, Christopher P.

doi:10.1016/j.jacc.2018.04.054

Cited by 273Lipoproteins and Cardiovascular HealthCholesterol and Lipid MetabolismAtherosclerosis and Cardiovascular Diseases

The Evolving Future of PCSK9 Inhibitors

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Rosenson, Robert S., Hegele, Robert A., Fazio, Sergio, Cannon, Christopher P.·2018·Journal of the American College of Cardiology

DOI 10.1016/j.jacc.2018.04.054

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Abstract

Variants in proprotein convertase subtilisin/kexin type 9 (PCSK9) provide insights into mechanisms regulating low-density lipoprotein (LDL) levels. Human monoclonal antibodies that target PCSK9 lower LDL cholesterol (LDL-C) levels by 55% to 72% in different high-risk patient groups. Clinical trials with PCSK9 inhibitors have demonstrated reductions in atherosclerotic cardiovascular disease events, particularly in patients with recent acute coronary syndrome, multivessel coronary artery disease, or peripheral arterial disease. Commonly observed profound reductions in LDL-C to levels <25 mg/dl have been accompanied by even lower rates of atherosclerotic cardiovascular disease events, thus supporting the concept that there may be no lower limit for LDL-C. Aggressive LDL-C lowering with fully human PCSK9 monoclonal antibodies has been accompanied by a safety profile that has been very favorable. On the basis of clinical trial evidence, LDL lowering with PCSK9 inhibitors is recommended for high-risk patients with LDL-C levels ≥70 mg/dl on maximally tolerated oral therapies including statins and/or ezetimibe.

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Patients with receptor-negative HoFH derive minimal benefit from PCSK9-targeted therapy, whereas receptor-defective HoFH and HeFH patients exhibit clinically meaningful LDL-C reductions.
“Patients with receptor-negative HoFH derive minimal benefit from PCSK9-targeted therapy, whereas receptor-defective HoFH and heterozygous FH (HeFH) patients exhibit clinically meaningful LDL-C reductions [84].”
From Inclisiran SiRNA therapy for durable LDL-C reduction: a systematic review and meta-analysis highlighting a breakthrough in long-term cardiovascular risk management (2026) · cites this paper as [84]
This resolution concept is likely relevant to humans because large reductions in plasma LDL-cholesterol cause regression of even advanced atherosclerotic lesions, and plaque regression is accompanied by fewer atherosclerotic cardiovascular disease events.
“This concept is likely to be relevant to humans because dramatic reductions in plasma LDL-cholesterol levels lead to the regression of even advanced atherosclerotic lesions, and plaque regression is accompanied by lower rates of atherosclerotic cardiovascular disease events210,211.”
From Inflammation and its resolution in atherosclerosis: mediators and therapeutic opportunities (2019) · cites this paper as [211]

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Research works printed but not linked: 5

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Authors: Rosenson, R. S., Hegele, R. A., Fazio, S., & Cannon, C. P.
Affiliations: Mount Sinai Hospital (US)
Western University (CA)
Oregon Health & Science University (US)
Brigham and Women's Hospital (US)
Corresponding author: Rosenson, Robert S.
ORCID: Rosenson, Robert S.
Hegele, Robert A.
Fazio, Sergio
Cannon, Christopher P.
Venue: Journal of the American College of Cardiology
Publisher: Elsevier BV
Published: 2018-07
Volume: 72
Issue: 3
Pages: 314-329
ISSN: 0735-1097 (ISSN-L)
DOI: 10.1016/j.jacc.2018.04.054
OpenAlex: W2848978533
Cited by: 264
References: 129
Citations by year: 2026: 18 · 2025: 39 · 2024: 34 · 2023: 47 · 2022: 31 · 2021: 35 · 2020: 27 · 2019: 26 · 2018: 7
FWCI: 5.28
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/open-access/userlicense/1.0/ (vor, 381 d)
Locations: Journal of the American College of Cardiology (publishedVersion)
PubMed (publishedVersion)
Funders: Amgen
Pfizer
AstraZeneca
Sanofi
American College of Cardiology Foundation
Regeneron Pharmaceuticals
Kowa Company
Topics: Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
Health Sciences › Medicine › Surgery › Cholesterol and Lipid Metabolism
Life Sciences › Immunology and Microbiology › Immunology › Atherosclerosis and Cardiovascular Diseases
Keywords: PCSK9 inhibitors, PCSK9, LDL cholesterol lowering, monoclonal antibodies, atherosclerotic cardiovascular disease, acute coronary syndrome, multivessel coronary artery disease, peripheral arterial disease, hypercholesterolemia
MeSH terms: Proprotein Convertase 9, PCSK9 Inhibitors, Antibodies, Monoclonal, Anticholesteremic Agents, Cardiovascular Diseases, Clinical Trials as Topic, Humans, Hypercholesterolemia, Cholesterol, LDL, Treatment Outcome, Antibodies, Monoclonal, Humanized

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The Evolving Future of PCSK9 Inhibitors

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