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高和极高心血管风险患者应用贝匹达酸降低 LDL 胆固醇目标达标率、治疗费用及 ASCVD 事件的模拟研究。

Simulation study on LDL cholesterol target attainment, treatment costs, and ASCVD events with bempedoic acid in patients at high and very-high cardiovascular risk.

机构信息

Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig, Leipzig, Germany.

Daiichi Sankyo Deutschland GmbH, München, Germany.

出版信息

PLoS One. 2022 Oct 27;17(10):e0276898. doi: 10.1371/journal.pone.0276898. eCollection 2022.


DOI:10.1371/journal.pone.0276898
PMID:36301892
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9612573/
Abstract

BACKGROUND AND AIMS: The LDL cholesterol (LDL-C) treatment goals recommended by the 2019 ESC/EAS guidelines are only achieved in a minority of patients. The study objective was to estimate the impact of bempedoic acid treatment on LDL-C target attainment, drug costs, and atherosclerotic cardiovascular disease (ASCVD) events. The simulation used a Monte Carlo approach in a representative cohort of German outpatients at high or very-high cardiovascular risk. Additionally to statins, consecutive treatment with ezetimibe, bempedoic acid, and a PCSK9 inhibitor was simulated in patients not achieving their LDL-C goal. Considered were scenarios without and with bempedoic acid (where bempedoic acid was replaced by a PCSK9 inhibitor when LDL-C was not controlled). RESULTS: The simulation cohort consisted of 105,577 patients, of whom 76,900 had very-high and 28,677 high cardiovascular risk. At baseline, 11.2% of patients achieved their risk-based LDL-C target. Sequential addition of ezetimibe and bempedoic acid resulted in target LDL-C in 33.1% and 61.9%, respectively. Treatment with bempedoic acid reduced the need for a PCSK9 inhibitor from 66.6% to 37.8% and reduced drug costs by 35.9% per year on stable lipid-lowering medication. Compared to using only statins and ezetimibe, this approach is projected to prevent additional 6,148 ASCVD events annually per 1 million patients, whereas PCSK9 inhibition alone would prevent 7,939 additional ASCVD events annually. CONCLUSIONS: A considerably larger proportion of cardiovascular high- and very-high-risk patients can achieve guideline-recommended LDL-C goals with escalated lipid-lowering medication. Bempedoic acid is projected to substantially decrease the need for PCSK9 inhibitor treatment to achieve LDL-C targets, associated with reduced drug costs albeit with fewer prevented events.

摘要

背景与目的:2019 年 ESC/EAS 指南推荐的 LDL 胆固醇(LDL-C)治疗目标仅在少数患者中得到实现。本研究旨在评估贝匹地酸治疗对 LDL-C 达标、药物费用和动脉粥样硬化性心血管疾病(ASCVD)事件的影响。该模拟采用蒙特卡罗方法,在德国高或极高心血管风险门诊患者的代表性队列中进行。在未达到 LDL-C 目标的患者中,除他汀类药物外,还连续使用依折麦布、贝匹地酸和 PCSK9 抑制剂进行治疗。考虑了无贝匹地酸和有贝匹地酸两种情况(无贝匹地酸时,当 LDL-C 未得到控制时,用 PCSK9 抑制剂替代贝匹地酸)。

结果:模拟队列包括 105577 例患者,其中 76900 例患者极高危,28677 例患者高危。基线时,11.2%的患者达到了基于风险的 LDL-C 目标。依折麦布和贝匹地酸的序贯添加分别使目标 LDL-C 达到 33.1%和 61.9%。贝匹地酸治疗将对 PCSK9 抑制剂的需求从 66.6%降低至 37.8%,每年稳定降脂药物的药物费用降低 35.9%。与仅使用他汀类药物和依折麦布相比,这种方法预计每年每 100 万患者可额外预防 6148 例 ASCVD 事件,而单独使用 PCSK9 抑制剂每年可额外预防 7939 例 ASCVD 事件。

结论:通过强化降脂药物治疗,可使更多的心血管高危和极高危患者达到指南推荐的 LDL-C 目标。贝匹地酸预计将大幅降低实现 LDL-C 目标所需的 PCSK9 抑制剂治疗需求,同时降低药物费用,但预防事件数量较少。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6136/9612573/10fa43a715b1/pone.0276898.g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6136/9612573/584ea56faf69/pone.0276898.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6136/9612573/dbfa94cfb559/pone.0276898.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6136/9612573/10fa43a715b1/pone.0276898.g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6136/9612573/584ea56faf69/pone.0276898.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6136/9612573/dbfa94cfb559/pone.0276898.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6136/9612573/10fa43a715b1/pone.0276898.g003.jpg

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引用本文的文献

[1]
Treatment pathways of lipid-lowering therapies in Germany 2016-2022.

Clin Res Cardiol. 2025-5-28

[2]
Expert opinion on the integration of combination therapy into the treatment algorithm for the management of dyslipidaemia: the integration of ezetimibe and bempedoic acid may enhance goal attainment.

Eur Heart J Cardiovasc Pharmacother. 2025-7-7

[3]
Treatment intensification with bempedoic acid to achieve LDL-C goal in patients with ASCVD: A simulation model using a real-world patient cohort in the US.

Atheroscler Plus. 2024-2-28

[4]
LDL cholesterol target attainment in cardiovascular high- and very-high-risk patients with statin intolerance: a simulation study.

Sci Rep. 2024-1-4

[5]
Simulation of bempedoic acid and ezetimibe in the lipid-lowering treatment pathway in Austria using the contemporary SANTORINI cohort of high and very high risk patients.

Wien Klin Wochenschr. 2023-7

本文引用的文献

[1]
Estimated cardiovascular benefits of bempedoic acid in patients with established cardiovascular disease.

Atheroscler Plus. 2022-5-28

[2]
Inter-Individual Variability in Lipid Response: A Narrative Review.

Am J Med. 2022-12

[3]
Real-world utilization of bempedoic acid in an academic preventive cardiology practice.

J Clin Lipidol. 2022

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Combination lipid-lowering therapy as first-line strategy in very high-risk patients.

Eur Heart J. 2022-2-22

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Target Populations and Treatment Cost for Bempedoic Acid and PCSK9 Inhibitors: A Simulation Study in a Contemporary CAD Cohort.

Clin Ther. 2021-9

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Cardiovasc Drugs Ther. 2021-8

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Eur J Prev Cardiol. 2021-3-23

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Rationale and design of the CLEAR-outcomes trial: Evaluating the effect of bempedoic acid on cardiovascular events in patients with statin intolerance.

Am Heart J. 2021-5

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