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维立西呱:首个可溶性鸟苷酸环化酶刺激剂,用于降低射血分数降低的心力衰竭患者的心血管死亡和心力衰竭住院风险。

Vericiguat: The First Soluble Guanylate Cyclase Stimulator for Reduction of Cardiovascular Death and Heart Failure Hospitalization in Patients With Heart Failure Reduced Ejection Fraction.

机构信息

Department of Pharmacotherapeutics & Clinical Research, Taneja College of Pharmacy, University of South Florida, Tampa, FL, USA.

Cardiovascular Sciences Division, Department of Internal Medicine, Morsani College of Medicine, University of South Florida, Tampa, FL, USA.

出版信息

J Pharm Pract. 2023 Aug;36(4):905-914. doi: 10.1177/08971900221087096. Epub 2022 Mar 31.

Abstract

This study aims to review the pharmacology, efficacy, and safety of the soluble guanylate cyclase stimulator, vericiguat, in patients with symptomatic congestive heart failure with ejection fraction less than 45% for the reduction of cardiovascular deaths. Also, to evaluate heart failure-related hospitalization in patients following a hospital discharge secondary to heart failure or those that require outpatient intravenous diuretics. MEDLINE/Pubmed and National Institutes of Health Clinical Trial Registry were searched between January 1989 to February 2021 using the following terms: , , , (was also known as) The following study designs were included in the analysis: phase I, II, and III clinical trials; systematic reviews; and meta-analyses. Articles were included if they were published in English and evaluated vericiguat pharmacology, pharmacokinetics, efficacy, and safety. The Food and Drug Administration approved vericiguat for the reduction of cardiovascular death and hospitalization after having a related hospitalization or the need for outpatient intravenous diuretics, in those with symptomatic chronic heart failure and ejection fraction less than 45%. In the VICTORIA trial, vericiguat demonstrated a 10% reduction in risk of death from cardiovascular causes or first hospitalization for heart failure compared with placebo. Vericiguat was well tolerated overall with hypotension, syncope, and anemia noted as the most common side effects, similar to the other agent in its class. Vericiguat may be appropriate as add-on therapy for patients already on guideline-directed medical therapy with recent decompensated HFrEF to reduce hospitalization.

摘要

本研究旨在回顾可溶性鸟苷酸环化酶刺激剂维立西呱在射血分数小于 45%的有症状充血性心力衰竭患者中的药理学、疗效和安全性,以降低心血管死亡。此外,评估心力衰竭相关住院治疗,包括因心力衰竭出院后或需要门诊静脉利尿剂的患者。在 1989 年 1 月至 2021 年 2 月期间,使用以下术语在 MEDLINE/Pubmed 和美国国立卫生研究院临床试验注册中心进行了检索:,,, (也称为) 分析中包括了以下研究设计:I 期、II 期和 III 期临床试验;系统评价;和荟萃分析。如果文章发表在英语中,并评估了维立西呱的药理学、药代动力学、疗效和安全性,则将其纳入分析。美国食品和药物管理局批准维立西呱用于降低心血管死亡风险和心力衰竭相关住院或需要门诊静脉利尿剂的心力衰竭患者的住院率。在 VICTORIA 试验中,与安慰剂相比,维立西呱降低了 10%的心血管原因死亡或心力衰竭首次住院风险。维立西呱总体上耐受性良好,低血压、晕厥和贫血是最常见的副作用,与该类别的其他药物相似。 维立西呱可能适合作为指南指导的医学治疗后近期心力衰竭失代偿的患者的附加治疗,以减少住院。

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