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Sustained-Release Ivabradine Hemisulfate in Patients With Systolic Heart Failure

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机构: [1]Department of Cardiology, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China [2]Department of Cardiology, Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region, Urumqi, China [3]Department of Cardiology, Guangdong Provincial People’s Hospital, Guangzhou, China [4]Department of Cardiology, Shengjing Hospital of China Medical University, Shenyang, China [5]Department of Cardiology, Bethune First Hospital of Jilin University, Changchun, China [6]Department of Cardiology, The First Hospital of Hebei Medical University, Shijiazhuang, China [7]Department of Cardiology, The Second Hospital of Shanxi Medical University, Taiyuan, China [8]Department of Cardiology, Chongqing University Three Gorges Hospital, Chongqing, China [9]Department of Cardiology, General Hospital of Ningxia Medical University, Yinchuan, China [10]Department of Cardiology, Haikou People’s Hospital, Haikou, China [11]Department of Cardiology, Qilu Hospital of Shandong University, Jinan, China [12]Department of Biostatistics, School of Public Health, Nanjing Medical University, Nanjing, China [13]Jiangsu Hengrui Pharmaceuticals, Lianyungang, China
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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.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.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.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.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).Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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出版当年[2021]版:
大类 | 1 区 医学
小类 | 1 区 心脏和心血管系统
最新[2025]版:
大类 | 1 区 医学
小类 | 1 区 心脏和心血管系统
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出版当年[2020]版:
Q1 CARDIAC & CARDIOVASCULAR SYSTEMS
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Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

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第一作者机构: [1]Department of Cardiology, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
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通讯机构: [1]Department of Cardiology, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China [*1]Department of Cardiology, The Second Affiliated Hospital, Zhejiang University School of Medicine, 88 Jiefang Road, Hangzhou, Zhejiang Province 310009, China.
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