达帕格列净对全身性右心室功能障碍患者的安全性和有效性:初步结果

IF 2.3 3区 医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS
M. Albertini , V. Waldmann , P. David , A. Barat , A.S. Chaussade , L. Iserin , M. Ladouceur
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引用次数: 0

摘要

导言心力衰竭(HF)是全身性右心室(sRV)成人的主要死因。已有研究表明,达帕格列净可减少心力衰竭患者因心力衰竭住院的次数,并减少射血分数降低患者的全因死亡。我们旨在评估达帕格列净对 sRV 患者的疗效和安全性。方法这是一项前瞻性、观察性、单中心研究。2023 年 3 月至 2024 年 3 月期间,纳入了所有在接受最佳药物治疗后仍有 sRV 功能障碍的无症状(NYHA ≥ 2)患者。对患者进行基线评估,并在引入达帕格列净后 3、6 和 12 个月进行评估。主要终点是 6 分钟步行距离。次要终点包括NT-proBNP、生活质量(KCCQ-12)、NYHA分级、全身和肺下心室收缩功能以及潜在的治疗相关副作用。平均年龄为 48 岁(范围:19-79 岁),20 名(62%)患者为男性,12 名(38%)患者患有先天性矫正的大动脉转位,20 名(62%)患者患有伴有心房转换的大动脉转位。20 名患者在 6 个月后有了初步结果。6分钟步行距离(558.0米对599.5米,P=0.11)和NT-proBNP(355.5 pg/mL 对 293.5,P=0.81)均无统计学意义上的明显改善。然而,患者的生活质量(80.5 vs. 92.0,P <0.01)和右心室整体纵向应变(-11.2% vs. -12.9,P <0.01)明显改善。这些初步结果表明,达帕格列净耐受性良好,并能改善sRV功能障碍患者的生活质量和右心室整体纵向应变。最终结果将为该人群使用达帕格列净的长期疗效提供重要数据。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Safety and efficacy of dapagliflozin in patients with systemic right ventricular dysfunction: Preliminary results

Introduction

Heart failure (HF) is the leading cause of death in adults with a systemic right ventricle (sRV). Dapagliflozin has been shown to reduce hospitalization for HF and all-cause death in patients with HF and reduced ejection fraction. The impact of dapagliflozin in patients with a sRV remains unknown.

Objective

We aimed to evaluate the efficacy and safety of dapagliflozin in patients with sRV.

Methods

This was a prospective, observational, single-center study. All symptomatic (NYHA  2) patients with a sRV dysfunction despite optimal medical treatment were included from March 2023 to March 2024. Patients were assessed at baseline and 3, 6 and 12 months after dapagliflozin introduction. The primary endpoint was the 6-minute walk distance. Secondary endpoints included NT-proBNP, quality of life (KCCQ-12), NYHA class, systemic and sub-pulmonary ventricular systolic function, and potential treatment-related side effects.

Expected results

A total of 32 patients were included. Mean age was 48 years (range: 19–79), 20 (62%) of patients were male, 12 (38%) had congenitally corrected transposition of the great arteries and 20 (62%) had transposition of the great arteries with atrial switch. Preliminary results at 6 months were available in 20 patients. There was no statistically significant improvement in 6-minute walk distance (558.0 m vs. 599.5, P = 0.11) nor NT-proBNP (355.5 pg/mL vs. 293.5, P = 0.81). However, the quality of life of patients (80.5 vs. 92.0, P < 0.01) and the right ventricle global longitudinal strain (−11.2% vs. −12.9, P < 0.01) significantly improved. The drug was well tolerated with no side effects reported (Fig. 1).

Perspectives

These preliminary results suggest that dapagliflozin is well tolerated and associated with improved quality of life and right ventricle global longitudinal strain in patients with sRV dysfunction. Final results will bring important data on long-term outcomes associated with dapagliflozin use in this population.

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来源期刊
Archives of Cardiovascular Diseases
Archives of Cardiovascular Diseases 医学-心血管系统
CiteScore
4.40
自引率
6.70%
发文量
87
审稿时长
34 days
期刊介绍: The Journal publishes original peer-reviewed clinical and research articles, epidemiological studies, new methodological clinical approaches, review articles and editorials. Topics covered include coronary artery and valve diseases, interventional and pediatric cardiology, cardiovascular surgery, cardiomyopathy and heart failure, arrhythmias and stimulation, cardiovascular imaging, vascular medicine and hypertension, epidemiology and risk factors, and large multicenter studies. Archives of Cardiovascular Diseases also publishes abstracts of papers presented at the annual sessions of the Journées Européennes de la Société Française de Cardiologie and the guidelines edited by the French Society of Cardiology.
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