Low-density lipoprotein cholesterol levels exceed the recommended European threshold for PCSK9i initiation: lessons from the HEYMANS study
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Supporting information
Author(s)
Type
Journal Article
Abstract
Aims To describe the characteristics of patients receiving evolocumab in clinical practice across 12 European countries and
simulate the association between low-density lipoprotein cholesterol (LDL-C) reduction and cardiovascular (CV) risk
reduction. .........................................................................................................................................................................................
Methods and
results
The characteristics of hyperlipidaemic patients at initiation of evolocumab and treatment patterns study—HEYMANS
(n = 1952) is a prospective registry of patients ≥18 years old who initiated evolocumab from 1 August 2015 onwards.
Mean (standard deviation) age was 60 (10.8), 85% had a prior CV event, 45% were diagnosed with familial hypercholesterolaemia (FH), and 60% had statin intolerance. At evolocumab initiation, 43% were receiving any statin, 16% were
receiving ezetimibe without statin, and 41% received no background lipid-lowering therapy (LLT), with LDL-C levels
reflecting local proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) reimbursement criteria. Median LDL-C
decreased from 3.98 to 1.63 mmol/L within 3 months of evolocumab initiation and was maintained over 24 months.
Overall, 58% achieved risk-based 2019 European Society of Cardiology/European Atherosclerosis Society LDL-C goals
but that proportion was higher (68%) in patients receiving background LLT compared with those not receiving background LLT (44%). In patients with atherosclerotic cardiovascular disease without FH, the simulated relative CV risk
reduction associated with evolocumab treatment was 34% (25–44%). .........................................................................................................................................................................................
Conclusion Across Europe, LDL-C levels at evolocumab initiation were three times higher than recommended thresholds for
PCSK9i initiation, reflecting disparities between implementation and guidelines. More patients attained risk-based LDLC goals when receiving evolocumab in combination with LLT vs. those not receiving combination therapy. Population
health could be improved and LDL-C goals better attained if LDL-C thresholds for PCSK9i reimbursement were
lowered, enabling more patients to receive combination therapy when needed
simulate the association between low-density lipoprotein cholesterol (LDL-C) reduction and cardiovascular (CV) risk
reduction. .........................................................................................................................................................................................
Methods and
results
The characteristics of hyperlipidaemic patients at initiation of evolocumab and treatment patterns study—HEYMANS
(n = 1952) is a prospective registry of patients ≥18 years old who initiated evolocumab from 1 August 2015 onwards.
Mean (standard deviation) age was 60 (10.8), 85% had a prior CV event, 45% were diagnosed with familial hypercholesterolaemia (FH), and 60% had statin intolerance. At evolocumab initiation, 43% were receiving any statin, 16% were
receiving ezetimibe without statin, and 41% received no background lipid-lowering therapy (LLT), with LDL-C levels
reflecting local proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) reimbursement criteria. Median LDL-C
decreased from 3.98 to 1.63 mmol/L within 3 months of evolocumab initiation and was maintained over 24 months.
Overall, 58% achieved risk-based 2019 European Society of Cardiology/European Atherosclerosis Society LDL-C goals
but that proportion was higher (68%) in patients receiving background LLT compared with those not receiving background LLT (44%). In patients with atherosclerotic cardiovascular disease without FH, the simulated relative CV risk
reduction associated with evolocumab treatment was 34% (25–44%). .........................................................................................................................................................................................
Conclusion Across Europe, LDL-C levels at evolocumab initiation were three times higher than recommended thresholds for
PCSK9i initiation, reflecting disparities between implementation and guidelines. More patients attained risk-based LDLC goals when receiving evolocumab in combination with LLT vs. those not receiving combination therapy. Population
health could be improved and LDL-C goals better attained if LDL-C thresholds for PCSK9i reimbursement were
lowered, enabling more patients to receive combination therapy when needed
Date Issued
2022-02-17
Date Acceptance
2022-02-14
Citation
European Heart Journal - Quality of Care and Clinical Outcomes, 2022, 8 (4)
ISSN
2058-5225
Publisher
Oxford University Press
Journal / Book Title
European Heart Journal - Quality of Care and Clinical Outcomes
Volume
8
Issue
4
Copyright Statement
© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.
This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License (https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License (https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
License URL
Identifier
http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000784520900001&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=1ba7043ffcc86c417c072aa74d649202
Subjects
Science & Technology
Life Sciences & Biomedicine
Cardiac & Cardiovascular Systems
Cardiovascular System & Cardiology
Evolocumab
PCSK9i
LDL-C
Registry
Guidelines
Cardiovascular risk
FAMILIAL HYPERCHOLESTEROLEMIA
CARDIOVASCULAR EVENTS
MANAGEMENT
EFFICACY
LIPIDS
Publication Status
Published
Date Publish Online
2022-02-17