Tardif Jean-Claude, Ford Ian, Tendera Michal, Bourassa Martial G, Fox Kim
Montreal Heart Institute, 5000 Belanger Street, Montreal, Quebec H1T 1C8, Canada.
Eur Heart J. 2005 Dec;26(23):2529-36. doi: 10.1093/eurheartj/ehi586. Epub 2005 Oct 7.
Ivabradine, a new I(f) inhibitor which acts specifically on the pacemaker activity of the sinoatrial node, is a pure heart rate lowering agent. Ivabradine has shown anti-ischaemic and anti-anginal activity in a placebo-controlled trial. The objective of this study was to compare the anti-anginal and anti-ischaemic effects of ivabradine and the beta-blocker atenolol.
In a double-blinded trial, 939 patients with stable angina were randomized to receive ivabradine 5 mg bid for 4 weeks and then either 7.5 or 10 mg bid for 12 weeks or atenolol 50 mg od for 4 weeks and then 100 mg od for 12 weeks. Patients underwent treadmill exercise tests at randomization (M(0)) and after 4 (M(1)) and 16 (M(4)) weeks of therapy. Increases in total exercise duration (TED) at trough at M(4) were 86.8+/-129.0 and 91.7+/-118.8 s with ivabradine 7.5 and 10 mg, respectively and 78.8+/-133.4 s with atenolol 100 mg. Mean differences (SE) when compared with atenolol 100 mg were 10.3 (9.4) and 15.7 (9.5) s in favour of ivabradine 7.5 and 10 mg (P<0.001 for non-inferiority). TED at M(1) improved by 64.2+/-104.0 s with ivabradine 5 mg and by 60.0+/-114.4 s with atenolol 50 mg (P<0.001 for non-inferiority). Non-inferiority of ivabradine was shown at all doses and for all criteria. The number of angina attacks was decreased by two-thirds with both ivabradine and atenolol.
Ivabradine is as effective as atenolol in patients with stable angina.
伊伐布雷定是一种新型的If抑制剂，可特异性作用于窦房结的起搏活动，是一种单纯的降低心率药物。在一项安慰剂对照试验中，伊伐布雷定已显示出抗缺血和抗心绞痛活性。本研究的目的是比较伊伐布雷定和β受体阻滞剂阿替洛尔的抗心绞痛和抗缺血作用。
在一项双盲试验中，939例稳定型心绞痛患者被随机分为接受伊伐布雷定5mg每日两次，共4周，然后7.5或10mg每日两次，共12周，或阿替洛尔50mg每日一次，共4周，然后100mg每日一次，共12周。患者在随机分组时（M(0)）以及治疗4周（M(1)）和16周（M(4)）后进行平板运动试验。在M(4)时，伊伐布雷定7.5mg和10mg组的总运动持续时间（TED）谷值增加分别为86.8±129.0秒和91.7±118.8秒，阿替洛尔100mg组为78.8±133.4秒。与阿替洛尔100mg相比，伊伐布雷定7.5mg和10mg组的平均差异（标准误）分别为10.3（9.4）秒和15.7（9.5）秒，有利于伊伐布雷定7.5mg和10mg组（非劣效性P<0.001）。伊伐布雷定5mg组M(1)时的TED改善了64.2±104.0秒，阿替洛尔50mg组改善了60.0±114.4秒（非劣效性P<0.001）。伊伐布雷定在所有剂量和所有标准下均显示出非劣效性。伊伐布雷定和阿替洛尔均可使心绞痛发作次数减少三分之二。
在稳定型心绞痛患者中，伊伐布雷定与阿替洛尔疗效相当。
