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The Evolving Future of PCSK9 Inhibitors
Open accessAbstract
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 heterozygous FH (HeFH) patients exhibit clinically meaningful LDL-C reductions [84].”
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“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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Metadata
- 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.
- 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)
- 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
- 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 › Cardiology and Cardiovascular Medicine › Lipoproteins and Cardiovascular Health
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Biochemistry › 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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