比索洛尔与依那普利初始6个月单药治疗对轻至中度慢性心力衰竭患者的临床疗效。来自CIBIS III试验的数据。

Clinical effects of initial 6 months monotherapy with bisoprolol versus enalapril in the treatment of patients with mild to moderate chronic heart failure. Data from the CIBIS III Trial.

作者信息

Dobre Daniela, van Veldhuisen Dirk J, Goulder Michael A, Krum Henry, Willenheimer Ronnie

机构信息

Department of Clinical Pharmacology, University Medical Centre Groningen, University of Groningen, Antonius Deusinglaan 1, 9713 AV, Groningen, The Netherlands.

出版信息

Cardiovasc Drugs Ther. 2008 Oct;22(5):399-405. doi: 10.1007/s10557-008-6116-9. Epub 2008 Jun 5.

DOI:10.1007/s10557-008-6116-9

PMID:18528751

Abstract

PURPOSE

To assess the clinical effects and safety profile of initial monotherapy with either bisoprolol or enalapril in elderly patients with heart failure (HF).

METHODS

In CIBIS III, 1010 patients with mild to moderate HF and age>or=65 years were randomized to monotherapy with either bisoprolol or enalapril for 6 months.

RESULTS

Bisoprolol had a similar effect as enalapril on the combined end-point of all-cause mortality or hospitalization (HR 1.02; p=0.90), as well as on each of the individual end-points. A trend towards fewer sudden deaths was observed with bisoprolol (NS). On the other hand, more cases of worsening HF requiring hospitalization or occurring while in hospital were observed in the bisoprolol group (HR 1.67; p=0.03). The two groups were similar with regard to treatment cessations and early introduction of the second drug.

CONCLUSIONS

Bisoprolol and enalapril had a similar effect on the combined end-point of mortality or hospitalization during 6 months monotherapy. However, more worsening HF events were observed in the bisoprolol group.

摘要

目的

评估比索洛尔或依那普利初始单药治疗老年心力衰竭（HF）患者的临床疗效和安全性。

方法

在CIBIS III研究中，1010例年龄≥65岁的轻至中度HF患者被随机分为比索洛尔或依那普利单药治疗组，为期6个月。

结果

比索洛尔在全因死亡率或住院的联合终点方面与依那普利效果相似（风险比1.02；p = 0.90），在各个单独终点方面也是如此。观察到比索洛尔组猝死病例有减少趋势（无统计学意义）。另一方面，比索洛尔组观察到更多需要住院或住院期间发生的HF恶化病例（风险比1.67；p = 0.03）。两组在治疗中断和早期加用第二种药物方面相似。