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2020年至2021年欧洲高危和极高危患者低密度脂蛋白胆固醇控制实施中的治疗差距:多国观察性圣托里尼研究

Treatment gaps in the implementation of LDL cholesterol control among high- and very high-risk patients in Europe between 2020 and 2021: the multinational observational SANTORINI study.

作者信息

Ray Kausik K, Haq Inaam, Bilitou Aikaterini, Manu Marius C, Burden Annie, Aguiar Carlos, Arca Marcello, Connolly Derek L, Eriksson Mats, Ferrières Jean, Laufs Ulrich, Mostaza Jose M, Nanchen David, Rietzschel Ernst, Strandberg Timo, Toplak Hermann, Visseren Frank L J, Catapano Alberico L

机构信息

Imperial Centre for Cardiovascular Disease Prevention, ICTU-Global, Imperial College London, London, UK.

Medical Affairs, Daiichi Sankyo Europe, Munich, Germany.

出版信息

Lancet Reg Health Eur. 2023 Apr 5;29:100624. doi: 10.1016/j.lanepe.2023.100624. eCollection 2023 Jun.

DOI:10.1016/j.lanepe.2023.100624
PMID:37090089
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10119631/
Abstract

BACKGROUND

European data pre-2019 suggest statin monotherapy is the most common approach to lipid management for preventing cardiovascular (CV) events, resulting in only one-fifth of high- and very high-risk patients achieving the 2019 ESC/EAS recommended low-density lipoprotein cholesterol (LDL-C) goals. Whether the treatment landscape has evolved, or gaps persist remains of interest.

METHODS

Baseline data are presented from SANTORINI, an observational, prospective study that documents the use of lipid-lowering therapies (LLTs) in patients ≥18 years at high or very high CV risk between 2020 and 2021 across primary and secondary care settings in 14 European countries.

FINDINGS

Of 9602 enrolled patients, 9044 with complete data were included (mean age: 65.3 ± 10.9 years; 72.6% male). Physicians reported using 2019 ESC/EAS guidelines as a basis for CV risk classification in 52.0% (4706/9044) of patients (overall: high risk 29.2%; very high risk 70.8%). However, centrally re-assessed CV risk based on 2019 ESC/EAS guidelines suggested 6.5% (308/4706) and 91.0% (4284/4706) were high- and very high-risk patients, respectively. Overall, 21.8% of patients had no documented LLTs, 54.2% were receiving monotherapy and 24.0% combination LLT. Median (interquartile range [IQR]) LDL-C was 2.1 (1.6, 3.0) mmol/L (82 [60, 117] mg/dL), with 20.1% of patients achieving risk-based LDL-C goals as per the 2019 ESC/EAS guidelines.

INTERPRETATION

At the time of study enrolment, 80% of high- and very high-risk patients failed to achieve 2019 ESC/EAS guidelines LDL-C goals. Contributory factors may include CV risk underestimation and underutilization of combination therapies. Further efforts are needed to achieve current guideline-recommended LDL-C goals.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT04271280.

FUNDING

This study is funded by Daiichi Sankyo Europe GmbH, Munich, Germany.

摘要

背景

2019年前的欧洲数据表明,他汀类药物单药治疗是预防心血管(CV)事件进行血脂管理的最常见方法,导致只有五分之一的高危和极高危患者达到2019年欧洲心脏病学会/欧洲动脉粥样硬化学会(ESC/EAS)推荐的低密度脂蛋白胆固醇(LDL-C)目标。治疗格局是否已经演变,或者差距是否仍然存在,仍然备受关注。

方法

本文展示了圣托里尼研究的基线数据,这是一项观察性前瞻性研究,记录了2020年至2021年期间14个欧洲国家初级和二级医疗机构中年龄≥18岁的高CV风险或极高CV风险患者使用降脂疗法(LLT)的情况。

研究结果

在9602名入组患者中,纳入了9044名有完整数据的患者(平均年龄:65.3±10.9岁;男性占72.6%)。医生报告称,52.0%(4706/9044)的患者将2019年ESC/EAS指南作为CV风险分类的依据(总体而言:高危患者占29.2%;极高危患者占70.8%)。然而,根据2019年ESC/EAS指南进行的中心重新评估显示,分别有6.5%(308/4706)和91.0%(4284/4706)的患者为高危和极高危患者。总体而言,21.8%的患者没有记录在案的LLT,54.2%的患者接受单药治疗,24.0%的患者接受联合LLT。LDL-C的中位数(四分位间距[IQR])为2.1(1.6,3.0)mmol/L(82[60,117]mg/dL),20.1%的患者根据2019年ESC/EAS指南达到了基于风险的LDL-C目标。

解读

在研究入组时,80%的高危和极高危患者未达到2019年ESC/EAS指南的LDL-C目标。促成因素可能包括CV风险低估和联合疗法使用不足。需要进一步努力以实现当前指南推荐的LDL-C目标。

试验注册

ClinicalTrials.gov标识符:NCT04271280。

资助

本研究由德国慕尼黑的第一三共欧洲有限公司资助。

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