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固定剂量复方制剂比索洛尔-氨氯地平治疗高血压的证据基础不断增加。

A growing evidence base for the fixed-dose combination of bisoprolol and amlodipine to manage hypertension.

机构信息

Merck KGaA, Darmstadt, Germany.

Department of Internal Medicine, Hypertension and Vascular Diseases, Medical University of Warsaw, Warsaw, Poland.

出版信息

Curr Med Res Opin. 2022 Jul;38(7):1047-1053. doi: 10.1080/03007995.2022.2072087. Epub 2022 May 13.

Abstract

OBJECTIVES

Hypertension is a major cause of morbidity and mortality worldwide. Although current drug therapies can be effective, management of hypertension is closely linked to patient adherence to therapy. A fixed-dose combination (FDC) of bisoprolol and amlodipine has shown to be effective and convenient, and to significantly improve patient adherence.

METHODS

This narrative review evaluates recent evidence from four studies which explore the efficacy, safety, and adherence of FDC bisoprolol and amlodipine in patients with hypertension: one observational study; two randomized clinical trials (RCTs); and one indirect comparison analysis.

RESULTS

All four studies support the efficacy of FDC bisoprolol and amlodipine in the management of hypertension, highlighting clinically meaningful reductions in systolic and diastolic blood pressure (BP), and high adherence. In a large cohort study exploring FDC bisoprolol and amlodipine in daily practice, high adherence improved BP and heart rate control versus baseline. In a Phase 3 RCT, FDC bisoprolol and amlodipine demonstrated superiority over monotherapies in BP control and a positive tolerability profile, further supporting its use to manage hypertension in second line following monotherapy. In another Phase 3 RCT, the combination of bisoprolol and amlodipine led to significant BP reductions versus monotherapy with amlodipine with a comparable safety profile. Finally, in the indirect treatment comparison, a low dose combination of bisoprolol and amlodipine showed a similar decrease in systolic BP compared with a maximum dose of amlodipine.

CONCLUSIONS

This review adds to growing evidence supporting the efficacy, safety, and tolerability of FDC bisoprolol and amlodipine in managing hypertension.

摘要

目的

高血压是全球发病率和死亡率的主要原因。尽管目前的药物治疗可能有效,但高血压的管理与患者对治疗的依从性密切相关。 比索洛尔和氨氯地平的固定剂量组合(FDC)已被证明是有效且方便的,并且可以显著提高患者的依从性。

方法

本综述评估了四项研究的最新证据,这些研究探讨了高血压患者中 FDC 比索洛尔和氨氯地平的疗效、安全性和依从性:一项观察性研究;两项随机临床试验(RCT);和一项间接比较分析。

结果

四项研究均支持 FDC 比索洛尔和氨氯地平在高血压治疗中的疗效,强调了收缩压和舒张压(BP)的临床意义降低,以及高依从性。在一项探索日常实践中 FDC 比索洛尔和氨氯地平的大型队列研究中,高依从性改善了 BP 和心率控制相对于基线。在一项 3 期 RCT 中,FDC 比索洛尔和氨氯地平在 BP 控制方面优于单药治疗,且具有良好的耐受性,进一步支持将其用于单药治疗后二线治疗高血压。在另一项 3 期 RCT 中,比索洛尔和氨氯地平联合治疗与单药氨氯地平治疗相比,导致 BP 显著降低,且安全性相似。最后,在间接治疗比较中,与氨氯地平的最大剂量相比,比索洛尔和氨氯地平的低剂量组合显示出相似的收缩压降低。

结论

本综述增加了越来越多的证据,支持 FDC 比索洛尔和氨氯地平治疗高血压的疗效、安全性和耐受性。

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