莫斯科医疗机构对 inclisiran 疗效的观察研究

A. Sapina, Y. Y. Varlamova, M. G. Papyrina, A. S. Bezymyannyy, E. Y. Vasilyeva
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引用次数: 0

摘要

目的评估2022年11月21日至2023年12月31日期间,PCSK9抑制剂(阿利库单抗、clisiran和evolocumab)对动脉粥样硬化性心血管疾病(ASCVD)和未能达到目标低密度脂蛋白胆固醇(LDL-C)水平的患者的疗效。在观察性研究中,50 名患者被纳入 inclisiran 治疗组,30 名患者被纳入对照组(接受 PCSK9 抑制剂(alirocumab,n=1;evolocumab,n=29)治疗的 ASCVD 患者)。所有参加研究的人员都进行了病史数据分析,并初步接受了心电图、超声心动图、颅外和下肢多普勒超声检查以及实验室检查(全血细胞计数、生化血液检查、血脂谱)。莫斯科国家医疗系统的三个医疗机构参与了这项研究。本文提供了自研究开始3个月以来的中期数据,以评估PCSK9靶向疗法对ASCVD患者的疗效。对比组在主要临床特征方面具有可比性。在分析普利西兰对 ASCVD 患者的降脂效果时,LDL-C 水平从 2,53±0,10 mmol/l 显著降至 110±0,08 mmol/l(降低了 56.5%),p<0,0001,77.5% 的受试者达到了 LDL-C <1,4 mmol/l 的目标水平。alirocumab/evolocumab的降脂效果分析表明,LDL-C从2,48±0,16 mmol/l显著降至1,07±0,11 mmol/l(降低了56.8%),p<0,0001。莫斯科的 ASCVD 患者使用 PCSK9 靶向疗法(阿利昔单抗或 inclisiran 或 evolocumab)可在 3 个月内达到临床指南中规定的目标 LDL-C 水平。
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Observational study of inclisiran effectiveness in Moscow healthcare
Aim. To evaluate the effectiveness of PCSK9 inhibitors (alirocumab, inclisiran and evolocumab) in patients with atherosclerotic cardiovascular disease (ASCVD) and failure to achieve the target low-density lipoprotein cholesterol (LDL-C) level for the period from November 21, 2022 to December 31, 2023.Material and methods. For the observational study, 50 patients were included in the inclisiran therapy group and 30 patients in the control group (patients with ASCVD receiving PCSK9 inhibitors (alirocumab, n=1; evolocumab, n=29)). All study participants had their anamnestic data analyzed, and initially underwent electrocardiography, echocardiography, extracranial and lower limb Doppler ultrasound, and laboratory tests (complete blood count, biochemical blood tests, lipid profile). Three medical organizations of the Moscow State Healthcare System participate in the study.Results. Interim data are presented to evaluate the effectiveness of PCSK9 targeted therapy in patients with ASCVD, obtained 3 months from the study start. The comparison groups were comparable in main clinical characteristics. When analyzing the lipid-lowering effect of inclisiran in the examined patients with ASCVD, LDL-C level significantly decreased from 2,53±0,10 mmol/l to 110±0,08 mmol/l (by 56,5%), p<0,0001, while the target LDL-C level <1,4 mmol/l was achieved by 77,5% of the subjects. Analysis of the lipid-lowering effect of alirocumab/evolocumab showed a significant LDL-C decrease from 2,48±0,16 mmol/l to 1,07±0,11 mmol/l (by 56,8%), p<0,0001.Conclusion. The use of PCSK9 targeted therapy (alirocumab or inclisiran or evolocumab) in patients with ASCVD in Moscow make it possible to achieve target LDL-C levels, which are indicated in clinical guidelines, by 3 months.
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来源期刊
Russian Journal of Cardiology
Russian Journal of Cardiology Medicine-Cardiology and Cardiovascular Medicine
CiteScore
2.20
自引率
0.00%
发文量
185
审稿时长
1 months
期刊介绍: Russian Journal of Cardiology has been issued since 1996. The language of this publication is Russian, with tables of contents and abstracts of all articles presented in English as well. Editor-in-Chief: Prof. Eugene V.Shlyakhto, President of the Russian Society of Cardiology. The aim of the journal is both scientific and practical, also with referring to organizing matters of the Society. The best of all cardiologic research in Russia is submitted to the Journal. Moreover, it contains useful tips and clinical examples for practicing cardiologists. Journal is peer-reviewed, with multi-stage editing. The editorial board is presented by the leading cardiologists from different cities of Russia.
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