The efficacy and safety of ivabradine hydrochloride versus atenolol in Chinese patients with chronic stable angina pectoris

• Published in: Pharmacoepidemiology and drug safety 2014-11, Vol.23 (11), p.1183-1191
• Main Authors: Li, Yan, Jing, Linde, Li, Yishi, Jiang, Jinfa, Wang, Zhirong, Wei, Jin, Li, Xingtao, Wang, Lin, Xia, Hao, Li, Tianfa, Liu, Shaowen, Xing, Bo, Yang, Zhenyu, Lu, Qinghua, Jiang, Rongjian, Xie, Ping, Shou, Xiling, Wang, Xiaofeng, Jia, Youhong
• Format: Article
• Language: English
• Subjects: Adult; Aged; Angina pectoris; Angina, Stable - drug therapy; Atenolol - administration & dosage; Atenolol - adverse effects; Atenolol - therapeutic use; Benzazepines - administration & dosage; Benzazepines - adverse effects; Benzazepines - therapeutic use; Biological and medical sciences; Blood Pressure; Cardiology. Vascular system; China; chronic stable angina pectoris; Clinical trial. Drug monitoring; Coronary heart disease; Double-Blind Method; Drug therapy; efficacy; Exercise Test; Female; General pharmacology; Heart; Heart Rate; Humans; ivabradine; Male; Medical sciences; Middle Aged; pharmacoepidemiology; Pharmacology; Pharmacology. Drug treatments; Safety
• ISSN: 1053-8569; 1099-1557
• DOI: 10.1002/pds.3628

ABSTRACT Purpose 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. Copyright © 2014 John Wiley & Sons, Ltd.