Sustained-Release Ivabradine Hemisulfate in Patients With Systolic Heart Failure,Journal of the American College of Cardiology

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Sustained-Release Ivabradine Hemisulfate in Patients With Systolic Heart Failure
Journal of the American College of Cardiology ( IF 24.0 ) Pub Date : 2022-08-01 , DOI: 10.1016/j.jacc.2022.05.027
Feiming Ye ₁ , Xiaofeng Wang ₂ , Shulin Wu ₃ , Shumei Ma ₄ , Yu Zhang ₅ , Gang Liu ₆ , Kunshen Liu ₆ , Zhiming Yang ₇ , Xiaohua Pang ₈ , Li Xue ₉ , Shijuan Lu ₁₀ , Ming Zhong ₁₁ , Jing Li ₁ , Hao Yu ₁₂ , Donghua Lou ₁₃ , Dongyang Cui ₁₃ , Xiaojie Xie ₁ , Jian'an Wang ₁ ,

Affiliation

Department of Cardiology, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Department of Cardiology, Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region, Urumqi, China.
Department of Cardiology, Guangdong Provincial People's Hospital, Guangzhou, China.
Department of Cardiology, Shengjing Hospital of China Medical University, Shenyang, China.
Department of Cardiology, Bethune First Hospital of Jilin University, Changchun, China.
Department of Cardiology, The First Hospital of Hebei Medical University, Shijiazhuang, China.
Department of Cardiology, The Second Hospital of Shanxi Medical University, Taiyuan, China.
Department of Cardiology, Chongqing University Three Gorges Hospital, Chongqing, China.
Department of Cardiology, General Hospital of Ningxia Medical University, Yinchuan, China.
Department of Cardiology, Haikou People's Hospital, Haikou, China.
Department of Cardiology, Qilu Hospital of Shandong University, Jinan, China.
Department of Biostatistics, School of Public Health, Nanjing Medical University, Nanjing, China.
Jiangsu Hengrui Pharmaceuticals, Lianyungang, China.

Background

Ivabradine has potent actions in reducing heart rate and improving clinical outcomes of chronic heart failure with reduced ejection fraction (HFrEF). At present, only the short-acting formulation of ivabradine is available that needs to be administered twice daily.

Objectives

This study sought to evaluate the role of ivabradine hemisulfate sustained release (SR), a novel long-acting formulation of ivabradine dosed once daily, in stable patients with HFrEF.

Methods

Patients with stabilized HFrEF in New York Heart Association functional class II-IV were enrolled and randomized to receive placebo or ivabradine SR in addition to standard medications. The primary endpoint was the change of left ventricular (LV) end-systolic volume index from baseline to week 32.

Results

We randomly assigned 181 patients to placebo and 179 patients to ivabradine SR. After 32 weeks, a significant improvement of LV end-systolic volume index from baseline was observed in both arms with a greater effect in the ivabradine SR arm. Ivabradine SR therapy also exhibited superiority in improving LV end-diastolic volume index, LV ejection fraction, resting heart rate, the Kansas City Cardiomyopathy Questionnaire score, and hospital admission for heart failure worsening and cardiovascular disease in comparison to placebo. Overall adverse events showed no difference between the treatment arms. There were fewer occurrences of worsening heart failure in the ivabradine SR arm.

Conclusions

The present study demonstrates that ivabradine SR once daily in addition to optimum standard therapy improved heart function in patients with HFrEF. (Clinical Trial of Systolic Heart Failure Treatment of IvabRadine Hemisulfate Sustained-release Tablets [FIRST]; NCT02188082)

中文翻译：

收缩性心力衰竭患者的缓释伊伐布雷定半硫酸盐

背景

伊伐布雷定在降低心率和改善射血分数降低的慢性心力衰竭 (HFrEF) 的临床结果方面具有有效作用。目前，只有伊伐布雷定的短效制剂可用，需要每天给药两次。

目标

本研究旨在评估伊伐布雷定半硫酸盐缓释剂 (SR) 在稳定的 HFrEF 患者中的作用，SR 是一种新型长效伊伐布雷定制剂，每天给药一次。

方法

纽约心脏协会功能分级 II-IV 中 HFrEF 稳定的患者被纳入并随机接受安慰剂或伊伐布雷定 SR 以及标准药物治疗。主要终点是左心室 (LV) 收缩末期容积指数从基线到第 32 周的变化。

结果

我们将 181 名患者随机分配至安慰剂组，将 179 名患者随机分配至伊伐布雷定 SR。32 周后，观察到两组左室收缩末期容积指数较基线显着改善，伊伐布雷定 SR 组效果更大。与安慰剂相比，伊伐布雷定 SR 疗法在改善左室舒张末期容积指数、左室射血分数、静息心率、堪萨斯城心肌病问卷评分和因心力衰竭恶化和心血管疾病住院方面也表现出优势。总体不良事件显示治疗组之间没有差异。伊伐布雷定 SR 组心力衰竭恶化的发生率较低。