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优化固定复方制剂培哚普利/氨氯地平治疗动脉高血压患者的血压。

Optimization of blood pressure treatment with fixed-combination perindopril/amlodipine in patients with arterial hypertension.

机构信息

Department of Cardiology, National Cardiovascular Institute and Slovak Medical University, Bratislava, Slovakia.

出版信息

Clin Drug Investig. 2012 Sep 1;32(9):603-12. doi: 10.1007/BF03261915.

Abstract

BACKGROUND

Fixed-dose combination treatments using an angiotensin-converting enzyme (ACE) inhibitor, such as perindopril, plus a calcium channel blocker (CCB), such as amlodipine, have been endorsed by guidelines because they improve blood pressure control and cardiovascular outcomes in hypertensive patients, while being well tolerated and well adhered to by patients.

OBJECTIVE

This study aimed to assess the blood pressure-lowering effects of fixed-combination perindopril/amlodipine in patients previously treated with an ACE inhibitor and/or a CCB.

METHODS

This was a prospective, real-life, open-label, longitudinal, phase IV study conducted in 223 outpatient medical centres across Slovakia. 2132 previously treated patients whose hypertension was insufficiently controlled at baseline or who tolerated treatment poorly were included. Patients were treated for 3 months with fixed-combination perindopril/amlodipine 5 mg/5 mg, 5 mg/10 mg, 10 mg/5 mg and 10 mg/10 mg. The main outcome measure was a reduction in mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) and achievement of blood pressure targets (SBP/DBP <140/90 mmHg or <130/80 mmHg for patients with type 2 diabetes mellitus or high cardiovascular risk).

RESULTS

After 3 months of treatment, mean ± SD SBP/DBP had decreased from 158.5 ± 17.5/93.6 ± 9.8 mmHg to 132.9 ± 10.6/80.7 ± 6.2 mmHg (p < 0.0001). In patients with grade 3 hypertension, mean ± SD changes from baseline in SBP/DBP were -45.4 ± 16.4/-20.0 ± 11.5 mmHg after 3 months (p < 0.0001). Blood pressure targets were reached by 74% of the overall patient population, 84% of patients with grade 1 hypertension, and 52% of difficult-to-treat patients with grade 3 hypertension. This treatment was associated with a 58% reduction in the number of patients with amlodipine-related ankle oedema compared with baseline.

CONCLUSION

Fixed-combination perindopril/amlodipine was well tolerated and resulted in statistically significant and clinically meaningful decreases in blood pressure.

摘要

背景

固定剂量联合治疗使用血管紧张素转换酶(ACE)抑制剂,如培哚普利,加钙通道阻滞剂(CCB),如氨氯地平,已被指南认可,因为它们改善血压控制和心血管结果在高血压患者中,同时被患者耐受和坚持。

目的

本研究旨在评估固定剂量联合培哚普利/氨氯地平在先前接受 ACE 抑制剂和/或 CCB 治疗的患者中的降压效果。

方法

这是一项前瞻性、真实生活、开放标签、纵向、四期研究,在斯洛伐克的 223 家门诊医疗中心进行。2132 名先前治疗的患者,其基线时高血压控制不足或不耐受治疗,被纳入研究。患者接受固定剂量联合培哚普利/氨氯地平 5 毫克/5 毫克、5 毫克/10 毫克、10 毫克/5 毫克和 10 毫克/10 毫克治疗 3 个月。主要观察指标为平均收缩压(SBP)和舒张压(DBP)的降低以及血压目标的实现(SBP/DBP <140/90mmHg 或 <130/80mmHg 用于 2 型糖尿病或高心血管风险患者)。

结果

治疗 3 个月后,平均 SBP/DBP 从 158.5 ± 17.5/93.6 ± 9.8mmHg 降至 132.9 ± 10.6/80.7 ± 6.2mmHg(p<0.0001)。在 3 级高血压患者中,SBP/DBP 从基线的平均变化为-45.4 ± 16.4/-20.0 ± 11.5mmHg(p<0.0001)。整体患者人群中有 74%达到了血压目标,1 级高血压患者中有 84%,3 级高血压中难以治疗的患者中有 52%达到了血压目标。与基线相比,这种治疗使与氨氯地平相关的踝部水肿相关的患者数量减少了 58%。

结论

固定剂量联合培哚普利/氨氯地平耐受性良好,可显著降低血压,具有临床意义。

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