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2017 Update of ESC/EAS Task Force on practical clinical guidance for proprotein convertase subtilisin/kexin type 9 inhibition in patients with atherosclerotic cardiovascular disease or in familial hypercholesterolaemia
Open accessAbstract
The first randomized controlled data from cardiovascular outcomes trials with proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors have now been reported.1 , 2 This ESC/EAS Task Force met to consider the impact on practical guidance for the use of these novel agents. This updated clinical guidance provides novel clinical decision algorithms when considering a PCSK9 inhibitor, and monitoring treatment efficacy to statin, ezetimibe and PCSK9 inhibitor. Gaps in knowledge for PCSK9 inhibition are also discussed. The Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk (FOURIER) trial (with evolocumab, a fully human monoclonal PCSK9 antibody) in 27 564 patients with atherosclerotic cardiovascular disease (ASCVD) was the first to be completed.1 The Evaluation of Bococizumab in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects (SPIRE)-1 and -2 trials were, however, stopped early following termination of bococizumab development due to effects specific to this antibody (Box 1).2 , 3 In FOURIER, lowering of low-density lipoprotein cholesterol (LDL-C) levels by 59% (from 2.4 mmol/L to 0.78 mmol/L) significantly reduced the risk of major cardiovascular events (absolute event rates 9.8% vs. 11.3% on placebo over 2.2 years, relative risk reduction of 15%). The clinical benefit of PCSK9 inhibitor treatment was due to reduction of nonfatal events, largely driven by reduction in myocardial infarction (MI) and coronary revascularization. This benefit was generally consistent across all major patient subgroups, including age, sex, and type of clinical presentation of ASCVD [coronary artery disease (CAD) with history of MI, ischaemic stroke and symptomatic peripheral arterial disease (PAD)], and accrued over time.1 Compared with the Cholesterol Treatment Trialists’ (CTT) Collaboration for cardiovascular benefit per mmol/L reduction in LDL-C, which is based on average response over 5 years on statin therapy, the observed benefit in FOURIER was shown to fall below the regression line. When adjusted for duration of treatment, however, as the benefit of a cholesterol lowering therapy in the first year of treatment is less than in the following years, the results from FOURIER were superimposable with those observed with statin therapy (Figure 1).4 Evidence from studies involving variants in the genes encoding PCSK9 and 3-hydroxy-3-methyl-glutaryl-CoA (HMGCoA) reductase provides further support for the concept that a similar risk reduction per unit LDL-C reduction is to be expected.5
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“discrepancies between biomarker and drug-target 97 can be informative for elucidating the 502 aetiology of disease and with it, shed light on new approaches to treating and preventing 503 disease.”
From Integrating genomics with biomarkers and therapeutic targets to invigorate cardiovascular drug development (2021) · cites this paper as [97]
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“colchicine 53 and icosapent ethyl 97 have both demonstrated efficacy in reduction of CVD in 494 recent large-scale phase III trials, however the precise mechanisms by which these drugs act, 495 i.e. the causal intermediaries, remains elusive.”
From Integrating genomics with biomarkers and therapeutic targets to invigorate cardiovascular drug development (2021) · cites this paper as [97]
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Self-citationEuropean Guidelines on cardiovascular disease prevention in clinical practice (version 2012)
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Self-citationEvolocumab and Clinical Outcomes in Patients with Cardiovascular Disease
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Metadata
- Authors
- Landmesser, U., Chapman, M. J., Stock, J. K., Amarenco, P., Belch, J. J. F., Borén, J., Farnier, M., Ference, B. A., Gielen, S., Graham, I., Grobbee, D. E., Hovingh, G. K., Lüscher, T. F., Piepoli, M. F., Ray, K. K., Stroes, E. S., Wiklund, O., Windecker, S., Zamorano, J. L., Pinto, F., Tokgözoğlu, L., Bax, J. J., & Catapano, A. L.
- Affiliations
- German Centre for Cardiovascular Research (DE)
- Inserm (FR)
- European Atherosclerosis Society (SE)
- Sorbonne Université (FR)
- Ninewells Hospital (GB)
- Sahlgrenska University Hospital (SE)
- CHU Dijon Bourgogne (FR)
- Wayne State University (US)
- University Hospital in Halle (DE)
- Trinity College Dublin (IE)
- University Medical Center Utrecht (NL)
- Amsterdam UMC Location University of Amsterdam (NL)
- University of Zurich (CH)
- Guglielmo da Saliceto Hospital (IT)
- Imperial College London (GB)
- University Hospital of Bern (CH)
- Department of Cardiology, University Hospital Ramón y Cajal, Madrid, Spain
- University of Lisbon (PT)
- Hacettepe University (TR)
- Leiden University Medical Center (NL)
- University of Milan (IT)
- Corresponding author
- Landmesser, Ulf
- ORCID
- Venue
- European Heart Journal
- Publisher
- Oxford University Press (OUP)
- Published
- 2017-10-16
- Volume
- 39
- Issue
- 14
- Pages
- 1131-1143
- ISSN
- 0195-668X (ISSN-L)
- 1522-9645
- OpenAlex
- W2766232664
- Cited by
- 200
- References
- 57
- Citations by year
- 2026: 3 · 2025: 1 · 2024: 5 · 2023: 7 · 2022: 12 · 2021: 26 · 2020: 30 · 2019: 62 · 2018: 50 · 2017: 4
- FWCI
- 40.91
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- European Heart Journal (publishedVersion)
- PubMed (publishedVersion)
- Discovery Research Portal (University of Dundee) (submittedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- BORIS (University Library Bern) (submittedVersion, other-oa)
- Utrecht University Repository (Utrecht University) (submittedVersion)
- Utrecht University Repository (Utrecht University) (submittedVersion, other-oa)
- Pure Amsterdam UMC (submittedVersion, other-oa)
- Portuguese National Funding Agency for Science, Research and Technology (RCAAP Project by FCT) (submittedVersion)
- Open Access CRIS of the University of Bern
- Funders
- Amgen
- Eli Lilly and Company
- Pfizer
- AstraZeneca
- Sanofi
- Edwards Lifesciences
- Boston Scientific Corporation
- Regeneron Pharmaceuticals
- Kowa Company
- Mylan
- Servier
- Esperion Therapeutics
- Daiichi Sankyo Europe
- 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, atherosclerotic cardiovascular disease, familial hypercholesterolemia, evolocumab, FOURIER trial, LDL cholesterol lowering, cardiovascular outcomes, clinical decision algorithm, treatment monitoring, bococizumab
- MeSH terms
- Proprotein Convertase 9, PCSK9 Inhibitors, Adult, Antibodies, Monoclonal, Anticholesteremic Agents, Coronary Artery Disease, Female, Humans, Hyperlipoproteinemia Type II, Male, Middle Aged, Advisory Committees, Antibodies, Monoclonal, Humanized
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