PMID- 38193606
OWN - NLM
STAT- MEDLINE
DCOM- 20240328
LR  - 20240404
IS  - 2055-5822 (Electronic)
IS  - 2055-5822 (Linking)
VI  - 11
IP  - 2
DP  - 2024 Apr
TI  - Effectiveness and safety of ivabradine in Chinese patients with chronic heart 
      failure: an observational study.
PG  - 846-858
LID - 10.1002/ehf2.14581 [doi]
AB  - AIMS: A therapeutic strategy for chronic heart failure (HF) is to lower resting 
      heart rate (HR). Ivabradine is a well-known HR-lowering agent, but limited 
      prospective data exist regarding its use in Chinese patients. This study aimed to 
      evaluate the effectiveness and safety of ivabradine in Chinese patients with 
      chronic HF. METHODS AND RESULTS: This multicentre, single-arm, prospective, 
      observational study enrolled Chinese patients with chronic HF. The primary 
      outcome was change from baseline in HR at 1 and 6 months, measured by pulse 
      counting. Effectiveness was also evaluated using laboratory tests, the Kansas 
      City Cardiomyopathy Questionnaire (KCCQ) clinical summary score (CSS) and overall 
      summary score (OSS), and New York Heart Association (NYHA) class. 
      Treatment-emergent adverse events (TEAEs) were assessed. A post hoc analysis 
      examined the effectiveness and safety of ivabradine combined with an angiotensin 
      receptor-neprilysin inhibitor (ARNI) or beta-blocker. A total of 1003 patients 
      were enrolled [mean age 54.4 +/- 15.0 years, 773 male (77.1%), mean baseline HR 
      88.5 +/- 11.3 b.p.m., mean blood pressure 115.7/74.4 +/- 17.2/12.3 mmHg, mean left 
      ventricular ejection fraction 30.9 +/- 7.6%, NYHA Classes III and IV in 48.8% and 
      22.0% of patients, respectively]. HR decreased by a mean of 12.9 and 16.1 b.p.m. 
      after 1 and 6 months, respectively (both P < 0.001). At Month 6, improvements in 
      the KCCQ CSS and OSS of >/=5 points were observed in 72.1% and 74.1% of patients, 
      respectively (both P < 0.001). Left ventricular ejection fraction increased by 
      12.1 +/- 11.6 (P < 0.001), and 66.7% of patients showed improvement in NYHA class 
      (P < 0.001). At Month 6, the overall proportion of patients in NYHA Classes III 
      and IV was reduced to 13.5% and 2.1%, respectively. Serum brain natriuretic 
      peptide (BNP) and N-terminal pro-BNP changed by -331.9 ng/L (-1238.6, -134.0) and 
      -1113.8 ng/L (-2202.0, -297.2), respectively (P < 0.001). HR reductions and 
      improvements in NYHA and KCCQ scores with ivabradine were similar with and 
      without use of ARNIs or beta-blockers. Of 498 TEAEs in 296 patients (29.5%), 73 
      TEAEs in 55 patients (5.5%) were considered related to ivabradine [most frequent 
      sinus bradycardia (n = 7) and photopsia (n = 7)]. TEAEs were reported in a 
      similar number of patients in ARNI and beta-blocker subgroups (21.9-35.6%). 
      CONCLUSIONS: Ivabradine treatment reduced HR and improved cardiac function and 
      health-related quality of life in Chinese patients with chronic HF. Benefits were 
      seen irrespective of whether or not patients were also taking ARNIs or 
      beta-blockers. Treatment was well tolerated with a similar profile to previous 
      ivabradine studies.
CI  - (c) 2024 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on 
      behalf of European Society of Cardiology.
FAU - Zhou, Jingmin
AU  - Zhou J
AD  - Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai 
      Institute of Cardiovascular Diseases, Shanghai, China.
FAU - Xu, Yamei
AU  - Xu Y
AD  - Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai 
      Institute of Cardiovascular Diseases, Shanghai, China.
FAU - Zheng, Zhaofen
AU  - Zheng Z
AD  - Hunan Provincial People's Hospital, Changsha, China.
FAU - Zhang, Shuyang
AU  - Zhang S
AD  - Peking Union Medical College Hospital, Beijing, China.
FAU - Yang, Jiefu
AU  - Yang J
AD  - Beijing Hospital, Beijing, China.
FAU - Zhang, Yuhui
AU  - Zhang Y
AD  - Fuwai Hospital, CAMS PUMC, Beijing, China.
FAU - Tang, Baopeng
AU  - Tang B
AD  - The First Affiliated Hospital of Xinjiang Medical University, Urumqi, China.
FAU - Han, Huiyuan
AU  - Han H
AD  - Shanxi Cardiovascular Hospital, Taiyuan, China.
FAU - Zhang, Qing
AU  - Zhang Q
AD  - West China Hospital, Sichuan University, Chengdu, China.
FAU - Liu, Fan
AU  - Liu F
AD  - The Second Hospital of Hebei Medical University, Shijiazhuang, China.
FAU - Ding, Wenhui
AU  - Ding W
AD  - Peking University First Hospital, Beijing, China.
FAU - Qian, Caizhen
AU  - Qian C
AD  - Zhuji People's Hospital, Shaoxing, China.
FAU - Su, Guohai
AU  - Su G
AD  - Jinan Central Hospital Affiliated to Shandong University, Jinan, China.
FAU - Liu, Xiaohui
AU  - Liu X
AD  - Beijing Anzhen Hospital, Capital Medical University, Beijing, China.
FAU - Shen, Yuansheng
AU  - Shen Y
AD  - Huizhou Municipal Central Hospital, Huizhou, China.
FAU - Shi, Bei
AU  - Shi B
AD  - Affiliated Hospital of Zunyi Medical College, Zunyi, China.
FAU - Kong, Xiangqing
AU  - Kong X
AD  - Jiangsu Province Hospital, Nanjing, China.
FAU - Ge, Zhiming
AU  - Ge Z
AD  - Qilu Hospital of Shandong University (Qingdao), Qingdao, China.
FAU - Zhang, Ping
AU  - Zhang P
AD  - Beijing Tsinghua Changgung Hospital, Beijing, China.
FAU - Guo, Xiaomei
AU  - Guo X
AD  - Tongji Hospital, Tongji Medical College, Huazhong University of Science and 
      Technology, Wuhan, China.
FAU - Zhang, Hong
AU  - Zhang H
AD  - First People's Hospital of Yunnan Province, Kunming, China.
FAU - Sun, Yuemin
AU  - Sun Y
AD  - Tianjin Medical University General Hospital, Tianjin, China.
FAU - Dong, Yugang
AU  - Dong Y
AD  - The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.
FAU - Fu, Guosheng
AU  - Fu G
AD  - Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Zhejiang, 
      China.
FAU - Feng, Lei
AU  - Feng L
AD  - Servier (Tianjin) Pharmaceutical Co., Ltd, Beijing, China.
FAU - Ge, Junbo
AU  - Ge J
AUID- ORCID: 0000-0002-9360-7332
AD  - Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai 
      Institute of Cardiovascular Diseases, Shanghai, China.
CN  - POSITIVE investigators
LA  - eng
GR  - Servier, China/
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
DEP - 20240109
PL  - England
TA  - ESC Heart Fail
JT  - ESC heart failure
JID - 101669191
RN  - 0 (Adrenergic beta-Antagonists)
RN  - 0 (Benzazepines)
RN  - 0 (Cardiovascular Agents)
RN  - 3H48L0LPZQ (Ivabradine)
RN  - photopsia
SB  - IM
MH  - Adult
MH  - Aged
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Adrenergic beta-Antagonists/therapeutic use
MH  - Benzazepines
MH  - *Cardiovascular Agents/therapeutic use
MH  - China
MH  - *Heart Failure
MH  - Ivabradine/therapeutic use
MH  - Prospective Studies
MH  - Quality of Life
MH  - Stroke Volume
MH  - Treatment Outcome
MH  - Ventricular Function, Left
MH  - *Vision Disorders
MH  - Female
PMC - PMC10966258
OTO - NOTNLM
OT  - Heart failure
OT  - Heart rate
OT  - Ivabradine
OT  - Real world
COIS- J.Z., Y.X., Z.Z., S.Z., J.Y., Y.Z., B.T., H.H., Q.Z., F.L., W.D., C.Q., G.S., 
      X.L., Y. Shen, B.S., X.K., Z.G., P.Z., X.G., H.Z., Y. Sun, Y.D., G.F., and J.G. 
      have received fees, research grants, or both from Servier. L.F. is an employee of 
      Servier.
EDAT- 2024/01/09 13:42
MHDA- 2024/03/28 06:44
PMCR- 2024/01/09
CRDT- 2024/01/09 09:01
PHST- 2023/08/12 00:00 [revised]
PHST- 2022/12/27 00:00 [received]
PHST- 2023/10/31 00:00 [accepted]
PHST- 2024/03/28 06:44 [medline]
PHST- 2024/01/09 13:42 [pubmed]
PHST- 2024/01/09 09:01 [entrez]
PHST- 2024/01/09 00:00 [pmc-release]
AID - EHF214581 [pii]
AID - 10.1002/ehf2.14581 [doi]
PST - ppublish
SO  - ESC Heart Fail. 2024 Apr;11(2):846-858. doi: 10.1002/ehf2.14581. Epub 2024 Jan 9.