PMID- 34878632 OWN - NLM STAT- MEDLINE DCOM- 20220504 LR - 20220716 IS - 1179-187X (Electronic) IS - 1175-3277 (Print) IS - 1175-3277 (Linking) VI - 22 IP - 3 DP - 2022 May TI - Real-World Effectiveness of Ivabradine in Chinese Patients with Chronic Heart Failure: Interim Analysis of the POSITIVE Study. PG - 345-354 LID - 10.1007/s40256-021-00500-x [doi] AB - 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. CI - (c) 2021. The Author(s). FAU - Jingmin, Zhou AU - Jingmin Z AD - Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, #180 Fenglin Road, Xuhui District, Shanghai, 200032, China. FAU - Yamei, Xu AU - Yamei X AD - Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, #180 Fenglin Road, Xuhui District, Shanghai, 200032, China. FAU - Yuhui, Zhang AU - Yuhui Z AD - Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. FAU - Wenhui, Ding AU - Wenhui D AD - Peking University First Hospital, Beijing, China. FAU - Baopeng, Tang AU - Baopeng T AD - The First Affiliated Hospital of Xinjiang Medical University, Urumqi, China. FAU - Caizhen, Qian AU - Caizhen Q AD - Zhuji People's Hospital of Zhejiang Province, Zhuji Affiliated Hospital of Wenzhou Medical University, Zhejiang, Zhuji, China. FAU - Huiyuan, Han AU - Huiyuan H AD - Shanxi Cardiovascular Hospital, Shanxi, Taiyuan, China. FAU - Junbo, Ge AU - Junbo G AUID- ORCID: 0000-0002-9360-7332 AD - Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, #180 Fenglin Road, Xuhui District, Shanghai, 200032, China. jbge@zs-hospital.sh.cn. CN - POSITIVE investigators LA - eng SI - ISRCTN/ISRCTN11703380 PT - Journal Article PT - Multicenter Study PT - Observational Study DEP - 20211208 PL - New Zealand TA - Am J Cardiovasc Drugs JT - American journal of cardiovascular drugs : drugs, devices, and other interventions JID - 100967755 RN - 0 (Benzazepines) RN - 0 (Cardiovascular Agents) RN - 3H48L0LPZQ (Ivabradine) SB - IM MH - Adult MH - Benzazepines/adverse effects MH - *Cardiovascular Agents/adverse effects MH - China MH - Chronic Disease MH - *Heart Failure MH - Heart Rate MH - Humans MH - Ivabradine/pharmacology/therapeutic use MH - Prospective Studies MH - Quality of Life MH - Treatment Outcome MH - Ventricular Function, Left PMC - PMC9061670 COIS- Zhou Jingmin, Xu Yamei, Zhang Yuhui, Ding Wenhui, Tang Baopeng, Qian Caizhen, Han Huiyuan, and Ge Junbo have received fees, research grants, or both, from Servier. FIR - Ge, Junbo IR - Ge J FIR - Lu, Jianhua IR - Lu J FIR - Jiang, Xianyan IR - Jiang X FIR - Shen, Yuansheng IR - Shen Y FIR - Guo, Xiaomei IR - Guo X FIR - Su, Guohai IR - Su G FIR - Zhang, Shuyang IR - Zhang S FIR - Yang, Jiefu IR - Yang J FIR - Zhao, Luosha IR - Zhao L FIR - Xu, Yan IR - Xu Y FIR - Zhang, Yuhui IR - Zhang Y FIR - Xiao, Jun IR - Xiao J FIR - Liu, Wenhui IR - Liu W FIR - Qiu, Zhaohui IR - Qiu Z FIR - Huang, Jingwen IR - Huang J FIR - Ge, Zhiming IR - Ge Z FIR - Feng, Li IR - Feng L FIR - Gao, Feng IR - Gao F FIR - Song, Haoming IR - Song H FIR - Zheng, Xiaoqun IR - Zheng X FIR - Chai, Xiaoli IR - Chai X FIR - Zhang, Ping IR - Zhang P FIR - Tang, Baopeng IR - Tang B FIR - Cheng, Xiaoshu IR - Cheng X FIR - Wang, Hengliang IR - Wang H FIR - Jin, Yanrong IR - Jin Y FIR - Fang, Shengxian IR - Fang S FIR - Ding, Wenhui IR - Ding W FIR - Wang, Zheng IR - Wang Z FIR - Qi, Xiaoyong IR - Qi X FIR - Huang, Kejun IR - Huang K FIR - Xu, Yawei IR - Xu Y FIR - Wu, Di IR - Wu D FIR - Qian, Caizhen IR - Qian C FIR - Sun, Yuemin IR - Sun Y FIR - Han, Huiyuan IR - Han H FIR - Cai, Shanglang IR - Cai S FIR - Li, Ying IR - Li Y FIR - Dong, Yugang IR - Dong Y FIR - Zhu, Jieming IR - Zhu J FIR - He, Ruili IR - He R FIR - Xu, Tao IR - Xu T FIR - Zheng, Zhaofen IR - Zheng Z FIR - Kong, Xiangqing IR - Kong X FIR - Zong, Wenxia IR - Zong W FIR - Cheng, Kang IR - Cheng K FIR - Huang, Dingshan IR - Huang D FIR - Fan, Zeyuan IR - Fan Z FIR - Fu, Guosheng IR - Fu G FIR - Li, Zhaoping IR - Li Z FIR - Liu, Xiaohui IR - Liu X FIR - Zhang, Hong IR - Zhang H FIR - Shi, Bei IR - Shi B FIR - Zhou, Tao IR - Zhou T FIR - Shen, Guidong IR - Shen G FIR - Luo, Jun IR - Luo J FIR - Zhong, Yiming IR - Zhong Y FIR - Zhang, Qing IR - Zhang Q FIR - Xie, Peiyi IR - Xie P FIR - Liu, Xiaohui IR - Liu X FIR - Liu, Fan IR - Liu F FIR - Qiu, Yuangang IR - Qiu Y FIR - Cheng, Manli IR - Cheng M EDAT- 2021/12/09 06:00 MHDA- 2022/05/06 06:00 PMCR- 2021/12/08 CRDT- 2021/12/08 12:27 PHST- 2021/09/03 00:00 [accepted] PHST- 2021/12/09 06:00 [pubmed] PHST- 2022/05/06 06:00 [medline] PHST- 2021/12/08 12:27 [entrez] PHST- 2021/12/08 00:00 [pmc-release] AID - 10.1007/s40256-021-00500-x [pii] AID - 500 [pii] AID - 10.1007/s40256-021-00500-x [doi] PST - ppublish SO - Am J Cardiovasc Drugs. 2022 May;22(3):345-354. doi: 10.1007/s40256-021-00500-x. Epub 2021 Dec 8.