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新型选择性If抑制剂伊伐布雷定与阿替洛尔治疗慢性稳定性心绞痛患者的疗效比较

Efficacy of ivabradine, a new selective I(f) inhibitor, compared with atenolol in patients with chronic stable angina.

作者信息

Tardif Jean-Claude, Ford Ian, Tendera Michal, Bourassa Martial G, Fox Kim

机构信息

Montreal Heart Institute, 5000 Belanger Street, Montreal, Quebec H1T 1C8, Canada.

出版信息

Eur Heart J. 2005 Dec;26(23):2529-36. doi: 10.1093/eurheartj/ehi586. Epub 2005 Oct 7.

Abstract

AIMS

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.

METHODS AND RESULTS

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.

CONCLUSION

Ivabradine is as effective as atenolol in patients with stable angina.

摘要

目的

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。

方法与结果

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。

结论

在稳定型心绞痛患者中,伊伐布雷定与阿替洛尔疗效相当。

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