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Curr Med Res Opin. 2018 Nov;34(11):1921-1926. doi: 10.1080/03007995.2018.1454895. Epub 2018 Apr 25.

Occurrence of composite cardiac endpoints with change in resting heart rate among Chinese patients with coronary artery disease: Chinese cohort from the real-world BISO-CAD study.

Chen Y1, Yang X2, Huang S3, Fu G4, Chen X5, Yang Y6, Liu S7, Xu H8, Ma T9, Zhou X10, Lv Z11, Yang M12, Gan X13, Xu D14, Cao F15, Liu H16, Li J17, Zheng Q18, Wang N19, Yuan Y20, Liu W21, Yang T22.

Author information

1
a Department of Cardiology , China PLA General Hospital , Beijing , China.
2
b Department of Cardiology , Beijing Chao-Yang Hospital, Capital Medical University , Beijing , China.
3
c Affiliated Hospital of Guangdong Medical College , China.
4
d Sir Run Run Shaw Hospital Affiliated with School of Medicine , Zhejiang University , China.
5
e West China Hospital , China.
6
f The Second Xiangya Hospital of Central South University , China.
7
g Shanghai First People's Hospital , China.
8
h Merck Serono China R&D , Beijing , China.
9
i Merck Serono Co. Ltd. , Beijing , China.
10
j First Affiliated Hospital of Dalian Medical University , China.
11
k Affiliated Hospital of North Sichuan Medical College , China.
12
l Fu Xing Hospital, Capital Medical University , China.
13
m Zhongnan Hospital of Wuhan University , China.
14
n Xuanwu Hospital Capital Medical University , China.
15
o The First Affiliated Hospital of the Fourth Military Medical University , China.
16
p Chinese Armed Police Force General Hospital , China.
17
q PLA, the Military General Hospital of Beijing , China.
18
r The Second Affiliated Hospital of the Fourth Military Medical University , China.
19
s The First People's Hospital of Hangzhou , China.
20
t The People's Hospital of Zhongshan City , China.
21
u Beijing Anzhen Hospital Capital Medical University , China.
22
v Xiangya Hospital of Central South University , China.

Abstract

OBJECTIVE:

We evaluated change in resting heart rate (RHR) and its impact on prognosis in Chinese coronary artery disease (CAD) patients treated with bisoprolol, and also assessed drug safety and tolerability.

METHODS:

This phase IV, single arm observational study was a sub-study of the BISO-CAD study conducted across 20 hospitals in China between October 2011 and July 2015 with follow-up at 6, 12 and 18 months after baseline. The primary endpoint was occurrence of composite cardiac events.

RESULTS:

A total of 663 CAD patients (baseline RHR 75.47 ± 6.62 bpm) were enrolled in the intent-to-treat (ITT) set, and 513 patients were included in the efficacy analysis (EA) set. In the ITT set, the risk and the number of composite cardiac events in patients with mean RHR 69-74 bpm were significantly higher than in the <65 bpm group (ITT: estimate 1.03 ± 0.47, p = .029). The incidence of the composite cardiac endpoint was not affected by continuous mean RHR (p = .5070). RHR significantly decreased from baseline to 18 months, most obviously in the first 6 months (p < .0001). Ejection fraction and fractional shortening significantly improved in both the ITT and EA sets. An average RHR of 69-74 bpm had a significant effect on admission to hospital for acute coronary syndrome in the ITT (estimate 1.10, HR 3.004, p = .0196) and EA (estimate 1.26, HR 3.526, p = .0132) groups. Seven (1.1%) patients reported drug related adverse events.

CONCLUSION:

Reduction in RHR with bisoprolol lowered the incidence of composite cardiac events along with an acceptable safety and tolerability profile.

KEYWORDS:

Chinese cohort; Resting heart rate; bisoprolol; composite cardiac endpoint; coronary heart disease

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