作者: Yan Li , Linde Jing , Yishi Li , Jinfa Jiang , Zhirong Wang
DOI: 10.1002/PDS.3628
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摘要: Purpose The aim of this study was to assess the efficacy and safety ivabradine (Iva) noninferiority atenolol (Aten) in Chinese patients with chronic stable angina pectoris. Methods In double-blind, double-dummy trial, symptomatic pectoris positive exercise tolerance test were randomized into Iva [5 or 7.5 mg bis die (BID)] Aten group (12.5 25 mg BID) according computer-generated random numbers for 12 weeks. Results One hundred sixty-eight 166 group. In a full analysis set, increases total duration (TED) 54.3 ± 120.1 seconds 5 mg 58.8 ± 114.7 seconds 12.5 mg at fourth week, 12th TED improved by 84.1 ± 130.5 seconds 77.8 ± 126.6 seconds (95%CI: −21.4–34.1 seconds, p = 0.0011 noninferiority). The per protocol set yielded similar results −31.4–33.0 seconds, p = 0.0131 Heart rate reduced both groups rest during peak exercise. There small, nonsignificant differences number adverse events between two (66 73 Aten, p > 0.05). Nine (5.42%) reported develop phosphenes/luminous phenomena blurred vision (p = 0.0035). Conclusions Iva is effective reducing heart rates improving capacity noninferior pectoris. well tolerated safe. Copyright © 2014 John Wiley & Sons, Ltd.