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在接受指南指导药物治疗的射血分数降低的心力衰竭患者中使用维立西呱:一项为期6个月的真实世界研究的见解

Vericiguat in heart failure with reduced ejection fraction patients on guideline-directed medical therapy: Insights from a 6-month real-world study.

作者信息

Tian Jiangyue, Dong Mei, Sun Xiaoqian, Jia Xiaoning, Zhang Guihua, Zhang Yanling, Lin Zongwei, Xiao Jie, Zhang Xinyu, Lu Huixia

机构信息

State Key Laboratory for Innovation and Transformation of Luobing Theory, Key Laboratory of Cardiovascular Remodeling and Function Research, Chinese Ministry of Education, Chinese National Health Commission and Chinese Academy of Medical Sciences, Department of Cardiology, Qilu Hospital of Shandong University, Jinan, China.

State Key Laboratory for Innovation and Transformation of Luobing Theory, Key Laboratory of Cardiovascular Remodeling and Function Research, Chinese Ministry of Education, Chinese National Health Commission and Chinese Academy of Medical Sciences, Department of Cardiology, Qilu Hospital of Shandong University, Jinan, China.

出版信息

Int J Cardiol. 2024 Dec 15;417:132524. doi: 10.1016/j.ijcard.2024.132524. Epub 2024 Sep 6.

Abstract

BACKGROUND

Vericiguat has demonstrated efficacy in improving the prognosis of patients with heart failure with reduced ejection fraction (HFrEF) following recent clinical deterioration. However, its real-world impact on reducing N-terminal B-type natriuretic peptide (NT-proBNP) levels and improving ventricular remodeling remains uncertain in stable HFrEF patients receiving guideline-directed medical therapy (GDMT) over the short term.

METHODS

This multicenter, observational cohort study included 200 HFrEF patients. Patients were grouped based on their preference for vericiguat use. We evaluated the impact of vericiguat on HFrEF patients by analyzing the difference in the proportion of patients with NT-proBNP levels ≤1000 pg/ml between two groups after a 6-month follow-up, using logistic regression and covariance analysis. Changes in echocardiographic parameters, left ventricular reverse remodeling (LVRR) ratio, and safety outcomes were also evaluated.

RESULTS

During the 6-month follow-up, 105 patients (82.68 %) in the vericiguat group and 46 patients (63.01 %) in the control group reached the primary endpoint. Multivariate logistic regression confirmed vericiguat as a significant factor in reducing NT-proBNP levels (Model 2: odds ratio (OR) = 2.67, 95 % confidence interval (CI): 1.24-5.77, P = 0.013), but it showed no significant association with LVRR (Model 2: OR = 0.52, 95 % CI: 0.24-1.13, P = 0.097). The safety analysis indicated a higher incidence of mild to moderate gastrointestinal symptoms in the vericiguat group compared to the control group (23.62 % vs. 2.74 %, P < 0.001).

CONCLUSIONS

Vericiguat significantly reduced NT-proBNP levels in patients with chronic HErEF under GDMT but was ineffective for LVRR during the 6-month follow-up.

摘要

背景

在近期临床病情恶化后,维立西呱已被证明可有效改善射血分数降低的心力衰竭(HFrEF)患者的预后。然而,在接受指南指导药物治疗(GDMT)的稳定HFrEF患者中,其在短期内降低N末端B型利钠肽(NT-proBNP)水平和改善心室重构方面的实际影响仍不确定。

方法

这项多中心观察性队列研究纳入了200例HFrEF患者。患者根据其对维立西呱使用的偏好进行分组。通过逻辑回归和协方差分析,我们分析了两组在6个月随访后NT-proBNP水平≤1000 pg/ml的患者比例差异,以评估维立西呱对HFrEF患者的影响。还评估了超声心动图参数、左心室逆向重构(LVRR)率和安全性结局的变化。

结果

在6个月的随访期间,维立西呱组105例患者(82.68%)和对照组46例患者(63.01%)达到主要终点。多因素逻辑回归证实维立西呱是降低NT-proBNP水平的重要因素(模型2:比值比(OR)=2.67,95%置信区间(CI):1.24-5.77,P=0.013),但它与LVRR无显著关联(模型2:OR=0.52,95%CI:0.24-1.13,P=0.097)。安全性分析表明,与对照组相比,维立西呱组轻度至中度胃肠道症状的发生率更高(23.62%对2.74%,P<0.001)。

结论

在GDMT下,维立西呱可显著降低慢性HFrEF患者的NT-proBNP水平,但在6个月的随访期间对LVRR无效。

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