Evolocumab 在瑞士临床实践中的应用:观察性 HEYMANS 队列研究的最终数据。

IF 2.6 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Therapeutic Advances in Cardiovascular Disease Pub Date : 2024-01-01 DOI:10.1177/17539447231213288
Isabella Sudano, Stephan Krähenbühl, François Mach, Anne Anstett, Nafeesa Dhalwani, Ian Bridges, Mahendra Sibartie, Kausik K Ray
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引用次数: 0

摘要

目的:HEYMANS 研究观察了接受 evolocumab 作为常规临床高脂血症治疗一部分的患者。该研究旨在获取与卫生部门和医生相关的临床参数数据:这是一项欧洲多国观察性队列序列图审查研究;本文报告了瑞士队列的数据。患者根据瑞士当时的报销标准处方依维莫司,并按时间顺序接受邀请。研究包括开始使用 evolocumab 前的 6 个月、12 个月的核心观察期(75 名患者进入观察期,74 名患者完成观察)和 18 个月的扩展观察期(40 名患者进入观察期,34 名患者完成观察)。首要目标是描述接受 evolocumab 治疗的患者的临床特征。次要目标包括描述血脂水平、evolocumab 的使用情况以及随着时间推移使用其他降脂疗法(LLT,即他汀类药物和/或依折麦布)的模式。研究于2017年5月至2021年6月期间在瑞士队列中进行:在瑞士常规治疗中接受 evolocumab 治疗的患者大多处于二级预防阶段(93%),有他汀类药物不耐受史(85%),其中 53% 的患者未接受任何背景 LLT 治疗。三分之一的患者患有家族性高胆固醇血症。患者开始使用 evolocumab 时的低密度脂蛋白胆固醇(LDL-C)中位数为 3.6 mmol/L,3 个月内下降了 54%,降至 1.6 mmol/L,此后保持稳定。总体而言,61%的患者实现了低密度脂蛋白胆固醇的目标:在瑞士的临床实践中,evolocumab主要用于心血管风险极高、低密度脂蛋白胆固醇水平极高的患者。大多数患者在整个研究期间都在继续使用依维莫司。这些患者的低密度脂蛋白胆固醇(LDL-C)在3个月内降低了50%以上,而且低密度脂蛋白胆固醇(LDL-C)的降低幅度一直保持不变。接受他汀类药物和/或依折麦布与 evolocumab 联合治疗的患者更容易达到指南推荐的这一极高风险人群的 LDL-C 目标:试验注册:ClinicalTrials.gov Identifier:NCT02770131。
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Evolocumab use in clinical practice in Switzerland: final data of the observational HEYMANS cohort study.

Aims: The HEYMANS study observed patients receiving evolocumab as part of routine clinical hyperlipidemia management. It was designed to capture data on clinical parameters relevant to health authorities and physicians.

Methods: This was a European multi-country observational cohort serial chart review study; data on the Swiss cohort are reported here. Patients were prescribed evolocumab as per the Swiss reimbursement criteria in force at the time and were invited chronologically. The study consisted of a 6-month period prior to initiation of evolocumab, a 12-month core observation period (entered by 75 patients, completed by 74 patients), and an 18-month extended observation period (entered by 40 patients, completed by 34 patients). The primary objective was to describe the clinical characteristics of patients receiving evolocumab. Secondary objectives included to describe lipid levels, evolocumab use, and patterns of use of other lipid-lowering therapies (LLT, that is, statins and/or ezetimibe) over time. The study was conducted in the Swiss cohort between May 2017 and June 2021.

Results: Patients who received evolocumab in Swiss routine practice mostly were in secondary prevention (93%) and had a history of statin intolerance (85%) with 53% receiving no background LLT. One-third had familial hypercholesterolemia. Patients initiated evolocumab at a median low-density lipoprotein cholesterol (LDL-C) of 3.6 mmol/L, which decreased by 54% within 3 months to 1.6 mmol/L and was stable thereafter. Overall, 61% achieved the LDL-C goal of <1.4 mmol/L with more patients attaining this goal when they received evolocumab with a statin and/or ezetimibe (84%) compared to 41% when receiving evolocumab alone. An LDL-C reduction of ⩾50% was achieved by 85% of patients. Persistence with evolocumab at 12 months was 85%.

Conclusion: In Swiss clinical practice, evolocumab was mainly prescribed to patients with very high cardiovascular risk, who had very high LDL-C levels. Most patients continued to use evolocumab throughout the study period. In these patients, LDL-C was reduced by >50% within 3 months and LDL-C reductions were maintained over time. Guideline-recommended LDL-C goals for this very high-risk cohort were more frequently attained in patients receiving a combination of statin and/or ezetimibe and evolocumab.

Trial registration: ClinicalTrials.gov Identifier: NCT02770131.

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来源期刊
Therapeutic Advances in Cardiovascular Disease
Therapeutic Advances in Cardiovascular Disease CARDIAC & CARDIOVASCULAR SYSTEMS-
CiteScore
3.50
自引率
0.00%
发文量
11
审稿时长
9 weeks
期刊介绍: The journal is aimed at clinicians and researchers from the cardiovascular disease field and will be a forum for all views and reviews relating to this discipline.Topics covered will include: ·arteriosclerosis ·cardiomyopathies ·coronary artery disease ·diabetes ·heart failure ·hypertension ·metabolic syndrome ·obesity ·peripheral arterial disease ·stroke ·arrhythmias ·genetics
期刊最新文献
Evolocumab use in clinical practice in Switzerland: final data of the observational HEYMANS cohort study. The impact of platelet-to-lymphocyte ratio on clinical outcomes in heart failure: a systematic review and meta-analysis. Vasospastic angina: a review on diagnostic approach and management. Percutaneous image-guided management of a misplaced pericardiocentesis catheter into the inferior vena cava. Safety and potential usefulness of sequential intracoronary acetylcholine and ergonovine administration for spasm provocation testing.
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