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在常规临床实践中用比索洛尔和培哚普利联合治疗高血压患者:CONFIDENCE II、PROTECT I 和 PROTECT III 观察性研究的事后分析。

Concomitant Treatment of Hypertensive Patients with Bisoprolol and Perindopril in Routine Clinical Practice: A Post Hoc Analysis of the CONFIDENCE II, PROTECT I, and PROTECT III Observational Studies.

机构信息

Institut de Recherches Internationales Servier (IRIS), Paris, France.

Trillium Health Partners, Mississauga, ON, Canada.

出版信息

Adv Ther. 2022 Jan;39(1):391-404. doi: 10.1007/s12325-021-01958-6. Epub 2021 Nov 10.

Abstract

INTRODUCTION

The combination of angiotensin-converting enzyme inhibitors and beta-blockers is recommended in a wide range of patients with hypertension, including those with stable coronary artery disease and/or elevated heart rate. This post hoc analysis of three observational studies provides effectiveness and safety data on treatment with perindopril on top of bisoprolol-based therapy, in routine clinical practice.

METHODS

Data were analyzed from three open-label, prospective, multicenter, observational studies of Canadian patients with mild-to-moderate hypertension, which shared the same inclusion and exclusion criteria, treatment duration, and primary outcome. This post hoc analysis focused on the subpopulation of patients treated with perindopril on top of bisoprolol-based therapy. All patients were followed for 16 weeks and underwent baseline, week 4, and week 16 visits. Primary outcomes were mean changes in blood pressure (BP) and proportion of patients achieving BP control (< 140/90 mmHg) in the full analysis set (FAS).

RESULTS

A total of 845 patients (mean age 68.3 ± 11.3 years, mean baseline BP 151.5/86.0 mmHg) were analyzed in the FAS. After 16 weeks, mean SBP/DBP decreased by - 20.4/- 9.8 mmHg with statistically significant reductions observed at all visits in all three studies allowing 78% of patients to achieve the BP treatment goal. No statistically significant changes in heart rate were observed and no serious adverse events reported. The most frequent doses of bisoprolol and perindopril were 5 + 4 mg (34.9%), followed by 5 + 8 mg (16.9%), and 2.5 + 4 mg (12.5%).

CONCLUSION

The addition of perindopril on top of bisoprolol-based therapy in patients with mild-to-moderate hypertension was associated with significant reductions in BP compared with baseline and with achievement of BP targets in the majority of patients. The results suggest this strategy is safe and effective for use in routine clinical practice.

摘要

简介

血管紧张素转换酶抑制剂和β受体阻滞剂的联合应用推荐于广泛的高血压患者,包括稳定型冠心病和/或心率增快的患者。这三项观察性研究的事后分析提供了在比索洛尔基础治疗上加用培哚普利的有效性和安全性数据,这些研究是在常规临床实践中进行的。

方法

该分析纳入了三项来自加拿大的轻中度高血压患者的开放性、前瞻性、多中心、观察性研究的数据,这些研究具有相同的纳入和排除标准、治疗持续时间和主要结局。该事后分析主要关注在比索洛尔基础上加用培哚普利的患者亚组。所有患者均随访 16 周,在基线、第 4 周和第 16 周时进行访视。主要结局为全分析集(FAS)中血压(BP)的平均变化和达到 BP 控制(<140/90mmHg)的患者比例。

结果

FAS 中共分析了 845 例患者(平均年龄 68.3±11.3 岁,平均基线 BP 151.5/86.0mmHg)。16 周后,SBP/DBP 平均下降了-20.4/-9.8mmHg,所有研究均在所有访视点观察到统计学显著降低,允许 78%的患者达到 BP 治疗目标。心率未观察到统计学显著变化,也未报告严重不良事件。比索洛尔和培哚普利最常见的剂量为 5+4mg(34.9%),其次是 5+8mg(16.9%)和 2.5+4mg(12.5%)。

结论

在轻中度高血压患者中,在比索洛尔基础治疗上加用培哚普利可显著降低血压,并使大多数患者达到 BP 目标。结果表明,该策略在常规临床实践中是安全有效的。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8f12/8799572/caafeb11c913/12325_2021_1958_Fig1_HTML.jpg

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