The efficacy and safety of ivabradine hydrochloride versus atenolol in Chinese patients with chronic stable angina pectoris.
OBJECTIVE
The aim of this study was to assess the efficacy and safety of ivabradine (Iva) noninferiority to atenolol (Aten) in Chinese patients with chronic stable angina pectoris.


METHODS
In this double-blind, double-dummy trial, patients with symptomatic angina pectoris and positive exercise tolerance test were randomized into the Iva [5 or 7.5 mg bis in die (BID)] or Aten group (12.5 or 25 mg BID) according to computer-generated random numbers for 12 weeks.


RESULTS
One hundred and sixty-eight patients were randomized to the Iva group and 166 to the Aten group. In a full analysis set, increases in the total exercise duration (TED) were 54.3 ± 120.1 seconds with Iva 5 mg and 58.8 ± 114.7 seconds with Aten 12.5 mg at the fourth week, and at the 12th week, TED improved by 84.1 ± 130.5 seconds with Iva and 77.8 ± 126.6 seconds with Aten (95%CI: -21.4-34.1 seconds, p = 0.0011 for noninferiority). The analysis of per protocol set yielded similar results (95%CI: -31.4-33.0 seconds, p = 0.0131 for noninferiority). Heart rate was reduced in both groups at rest and during peak exercise. There were small, nonsignificant differences in the number of adverse events between the two groups (66 in Iva and 73 in Aten, p > 0.05). Nine patients (5.42%) were reported to develop phosphenes/luminous phenomena and blurred vision in the Iva group (p = 0.0035).


CONCLUSIONS
Iva is effective in reducing heart rates and improving exercise capacity and noninferior to Aten in Chinese patients with chronic stable angina pectoris. Iva is well tolerated and safe.
Center of Clinical Pharmacology, Key Laboratory of Clinical Trial Research in Cardiovascular Drugs, Ministry of Health, State Key Laboratory of Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Yan
Y
Li
Linde
L
Jing
Yishi
Y
Li
Jinfa
J
Jiang
Zhirong
Z
Wang
Jin
J
Wei
Xingtao
X
Li
Lin
L
Wang
Hao
H
Xia
Tianfa
T
Li
Shaowen
S
Liu
Bo
B
Xing
Zhenyu
Z
Yang
Qinghua
Q
Lu
Rongjian
R
Jiang
Ping
P
Xie
Xiling
X
Shou
Xiaofeng
X
Wang
Youhong
Y
Jia
D000328:Adult; D000368:Aged; D060050:Angina, Stable / Q000188:drug therapy*; D001262:Atenolol / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001552:Benzazepines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001794:Blood Pressure; D002681:China; D004311:Double-Blind Method; D005080:Exercise Test; D005260:Female; D006339:Heart Rate; D006801:Humans; D000077550:Ivabradine; D008297:Male; D008875:Middle Aged
D001552:Benzazepines; D000077550:Ivabradine; D001262:Atenolol
chronic stable angina pectoris; efficacy; ivabradine; pharmacoepidemiology; safety