López-Bescós Lorenzo, Filipova Slavomira, Martos Ramón
Fundación Hospital Alcorcon, Alcorcon, Madrid, Spain.
Cardiology. 2007;108(4):387-96. doi: 10.1159/000108387. Epub 2007 Sep 21.
To assess the long-term safety and antianginal efficacy of two doses of ivabradine, a novel selective and specific inhibitor of the sinus node I(f) current.
In a randomized double-blind, parallel-group study 386 patients with chronic stable angina were randomized to either ivabradine 5 mg b.i.d. (n = 198, group 1) or ivabradine 7.5 mg b.i.d. (n = 188, group 2) for 12 months. Concomitant medication included antithrombotic agents, lipid-lowering agents, long-acting nitrates and dihydropyridine calcium antagonists. Safety was assessed on the basis of reported adverse events at 1, 3, 6, 9 and 12 months. Antianginal efficacy was based on the reduction in the weekly number of angina attacks and in the consumption of short-acting nitrates from month 0 (baseline) to month 12.
Ivabradine was well tolerated. Phosphene-like mild transient visual symptoms were the most frequently reported adverse events but led to treatment withdrawal in only 4 patients. Resting heart rate was reduced by 9 bpm in group 1 and 12 bpm in group 2. Sinus bradycardia caused treatment withdrawal in only three cases. The QTc (Bazett) interval did not increase. At month 12 relative to month 0 there was a significant reduction in the number of angina attacks per week.
Ivabradine at the recommended doses of 5 and 7.5 mg b.i.d. was well tolerated and demonstrated antianginal efficacy in patients with documented coronary artery disease treated with concomitant antianginal medications.
评估两种剂量的伊伐布雷定（一种新型的、选择性及特异性的窦房结I(f)电流抑制剂）的长期安全性及抗心绞痛疗效。
在一项随机双盲、平行组研究中，386例慢性稳定型心绞痛患者被随机分为伊伐布雷定5mg每日两次组（n = 198，第1组）或伊伐布雷定7.5mg每日两次组（n = 188，第2组），治疗12个月。伴随用药包括抗血栓药物、降脂药物、长效硝酸盐类药物及二氢吡啶类钙拮抗剂。根据1、3、6、9及12个月时报告的不良事件评估安全性。抗心绞痛疗效基于从第0个月（基线）至第12个月每周心绞痛发作次数及短效硝酸盐类药物消耗量的减少。
伊伐布雷定耐受性良好。最常报告的不良事件为类似闪光幻觉的轻度短暂视觉症状，但仅4例患者因此停药。第1组静息心率降低9次/分钟，第2组降低12次/分钟。窦性心动过缓仅导致3例患者停药。QTc（Bazett）间期未增加。与第0个月相比，第12个月时每周心绞痛发作次数显著减少。
推荐剂量为5mg及7.5mg每日两次的伊伐布雷定耐受性良好，在接受抗心绞痛药物联合治疗的冠状动脉疾病患者中显示出抗心绞痛疗效。
