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伊伐布雷定抑制If电流在不同亚组稳定型心绞痛患者中的疗效。

Efficacy of I(f) inhibition with ivabradine in different subpopulations with stable angina pectoris.

作者信息

Tendera Michal, Borer Jeffrey S, Tardif Jean-Claude

机构信息

3rd Division of Cardiology, Medical University of Silesia, Katowice, Poland.

出版信息

Cardiology. 2009;114(2):116-25. doi: 10.1159/000219938. Epub 2009 May 26.

Abstract

OBJECTIVES

The antianginal and anti-ischemic efficacy of ivabradine has been demonstrated in large-scale trials. Pooling trial data allowed for subpopulation analyses of ivabradine's antianginal efficacy.

METHODS

Data on the frequency of angina attacks, short-acting nitrate consumption, and heart rate were pooled from 5 randomized trials in patients with stable angina pectoris receiving 5, 7.5, or 10 mg of ivabradine b.i.d. for 3 or 4 months. The subpopulations were defined according to age, sex, disease characteristics, and comorbidities (severity of angina, history of myocardial infarction, cerebrovascular disease, revascularization status, diabetes, asthma/chronic obstructive pulmonary disease, or peripheral vascular disease).

RESULTS

Efficacy data were available for 2,425 patients (full analysis set), in whom ivabradine reduced the frequency of diary-based angina attacks by 59.4% and nitrate consumption by 53.7%. All subpopulations experienced 51-70% reductions in the frequency of angina attacks, with similar reductions for the other parameters studied. Ivabradine's efficacy was maintained in the presence of different comorbidities. In the safety set, ivabradine reduced heart rate by 14.5%. Ivabradine had a good safety and tolerability profile in all the subpopulations assessed.

CONCLUSIONS

The antianginal efficacy of ivabradine was consistent across all the subpopulations analyzed, independent of the severity of angina and the presence of a comorbidity.

摘要

目的

伊伐布雷定的抗心绞痛和抗缺血疗效已在大规模试验中得到证实。汇总试验数据有助于对伊伐布雷定的抗心绞痛疗效进行亚组分析。

方法

从5项随机试验中汇总了稳定性心绞痛患者的数据,这些患者接受5、7.5或10mg伊伐布雷定每日两次,治疗3或4个月,数据包括心绞痛发作频率、短效硝酸酯类药物使用情况和心率。亚组根据年龄、性别、疾病特征和合并症(心绞痛严重程度、心肌梗死病史、脑血管疾病、血运重建状态、糖尿病、哮喘/慢性阻塞性肺疾病或外周血管疾病)进行定义。

结果

有2425例患者(完整分析集)的疗效数据可用,伊伐布雷定使基于日记的心绞痛发作频率降低了59.4%,硝酸酯类药物使用量降低了53.7%。所有亚组的心绞痛发作频率均降低了51%-70%,其他研究参数也有类似程度的降低。在存在不同合并症的情况下,伊伐布雷定的疗效得以维持。在安全性分析集中,伊伐布雷定使心率降低了14.5%。在所有评估的亚组中,伊伐布雷定具有良好的安全性和耐受性。

结论

在所有分析的亚组中,伊伐布雷定的抗心绞痛疗效是一致的,与心绞痛的严重程度和合并症的存在无关。

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