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

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 7.5mg bis in die (BID)] or Aten group (12.5 or 25mg BID) according to computer-generated random numbers for 12weeks. 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±120.1seconds with Iva 5mg and 58.8±114.7seconds with Aten 12.5mg at the fourth week, and at the 12th week, TED improved by 84.1±130.5seconds with Iva and 77.8±126.6seconds with Aten (95%CI: -21.4-34.1seconds, p=0.0011 for noninferiority). The analysis of per protocol set yielded similar results (95%CI: -31.4-33.0seconds, 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.