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- Title
Real-World Effectiveness of Ivabradine in Chinese Patients with Chronic Heart Failure: Interim Analysis of the POSITIVE Study.
- Authors
Jingmin, Zhou; Yamei, Xu; Yuhui, Zhang; Wenhui, Ding; Baopeng, Tang; Caizhen, Qian; Huiyuan, Han; Junbo, Ge; The POSITIVE investigators; Ge, Junbo; Lu, Jianhua; Jiang, Xianyan; Shen, Yuansheng; Guo, Xiaomei; Su, Guohai; Zhang, Shuyang; Yang, Jiefu; Zhao, Luosha; Xu, Yan; Zhang, Yuhui
- Abstract
Background: Ivabradine improves cardiac function and clinical outcomes in chronic heart failure (HF) by reducing heart rate (HR), but there is a lack of real-world data on its effectiveness and safety in Chinese patients. Methods: We designed a prospective, multicenter, observational study of Chinese adults with HF and left ventricular systolic dysfunction, resting HR ≥ 75 beats per minute (bpm), and an indication for ivabradine treatment. An interim analysis was performed using a cut-off date of 31 October 2019. The primary outcome was change in HR at 6 months after the initiation of ivabradine. Secondary endpoints included change in New York Heart Association (NYHA) functional class; quality of life (QoL), measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ); and adverse events (AEs). Results: Overall, 655 subjects were included in the interim analysis. Mean reduction in HR from baseline was 13.2 (95% confidence interval [CI] 11.2–15.2) bpm at Month 1, and 14.5 (95% CI 11.8–17.2) bpm at Month 6 (p < 0.001 for both changes). NYHA functional class and KCCQ scores improved significantly over time (p < 0.001 for all comparisons with baseline), indicating amelioration of symptoms and better QoL, respectively. Forty-four subjects (6.7%) reported a total of 60 ivabradine-related AEs, most frequently phosphenes and bradycardia (both n = 6, 0.9%). Conclusion: Treatment with ivabradine for 6 months effectively reduced HR and improved functional class and QoL in Chinese patients with chronic HF. Treatment was well tolerated. Clinical Trial Registration: ISRCTN11703380; registered on 8 November 2016.
- Subjects
CHINA; DRUG efficacy; RESEARCH; SCIENTIFIC observation; CONFIDENCE intervals; LEFT ventricular dysfunction; HETEROCYCLIC compounds; FUNCTIONAL status; TREATMENT effectiveness; SEVERITY of illness index; HEART beat; QUALITY of life; DESCRIPTIVE statistics; QUESTIONNAIRES; VISION disorders; BRADYCARDIA; HEART failure; LONGITUDINAL method; EVALUATION
- Publication
American Journal of Cardiovascular Drugs, 2022, Vol 22, Issue 3, p345
- ISSN
1175-3277
- Publication type
Article
- DOI
10.1007/s40256-021-00500-x