基于自我测量早晚家庭血压指导的氨氯地平持续降压效果研究：At-HOME 研究的亚组分析。

Study of sustained blood pressure-lowering effect of azelnidipine guided by self-measured morning and evening home blood pressure: subgroup analysis of the At-HOME study.

机构信息

Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, 3311-1 Yakushiji, Shimotsuke, Tochigi, 329-0498, Japan.

出版信息

Drugs R D. 2013 Mar;13(1):75-85. doi: 10.1007/s40268-013-0007-7.

DOI:10.1007/s40268-013-0007-7

PMID:23519655

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3627021/

Abstract

BACKGROUND

Morning hypertension is a risk factor for cardiovascular and cerebrovascular events, and consequently diagnosis and control of morning hypertension are considered very important. We previously reported the results of the Azelnidipine Treatment for Hypertension Open-label Monitoring in the Early morning (At-HOME) Study, which indicated that azelnidipine effectively controlled morning hypertension.

OBJECTIVES

The objective of this At-HOME subgroup analysis was to evaluate the sustained blood pressure (BP)-lowering effect of azelnidipine, using mean morning and evening systolic BP [ME average] and morning systolic BP minus evening systolic BP (ME difference).

METHODS

We analyzed the self-measured home BP data (measured in the morning and at bedtime) from this 16-week prospective observational study to clarify the effect of morning dosing of azelnidipine (mean [± standard deviation] maximum dose 14.3 ± 3.6 mg/day). A subgroup of patients from the At-HOME Study who had an evening home BP measurement within 28 days prior to the baseline date were used for efficacy analysis (n = 2,546; mean age, 65.1 years; female, 53.6 %).

RESULTS

Home systolic BP/diastolic BP levels in the morning and evening were significantly lowered (p < 0.0001) by -19.4 ± 17.1/-10.3 ± 10.6 and -16.9 ± 17.0/-9.4 ± 10.6 mmHg, respectively. Home pulse rates in the morning and evening were also significantly lowered (p < 0.0001) by -3.5 ± 7.8 and -3.5 ± 7.3 beats/min, respectively. At baseline, patients whose ME average was ≥135 mmHg and whose ME difference was ≥15 mmHg (defined as morning-predominant hypertension) accounted for 20.4 % of the study population. However, at the end of the study, the number of such patients was significantly reduced to 7.9 % (p < 0.0001). Patients whose ME average was ≥135 mmHg and whose ME difference was <15 mmHg (defined as sustained hypertension) accounted for 71.1 % of the study population at baseline. This was reduced significantly to 42.8 % at the end of the study (p < 0.0001). ME average decreased significantly from 153.8 ± 15.5 mmHg to 135.6 ± 11.9 mmHg, and ME difference also decreased significantly from 6.7 ± 13.1 mmHg to 4.7 ± 10.8 mmHg (both p < 0.0001).

CONCLUSION

These results suggest that azelnidipine improved morning hypertension with its sustained BP-lowering effect.

摘要

背景

清晨高血压是心血管和脑血管事件的一个危险因素，因此，清晨高血压的诊断和控制被认为非常重要。我们之前报告了阿折地平治疗高血压开放标签监测在清晨（At-HOME）研究的结果，该研究表明阿折地平能有效控制清晨高血压。

目的

本 At-HOME 亚组分析的目的是评估阿折地平的持续降压作用，使用平均清晨和傍晚收缩压[ME 平均值]和清晨收缩压减去傍晚收缩压（ME 差值）。

方法

我们分析了这项为期 16 周的前瞻性观察研究中的自我测量家庭血压数据（在清晨和睡前测量），以明确清晨给予阿折地平（平均[±标准偏差]最大剂量 14.3 ± 3.6 mg/天）的效果。At-HOME 研究中，在基线日期前 28 天内有一次傍晚家庭血压测量的患者亚组用于疗效分析（n = 2546；平均年龄 65.1 岁；女性 53.6%）。

结果

清晨和傍晚的家庭收缩压/舒张压水平分别显著降低（p < 0.0001），分别为-19.4 ± 17.1/-10.3 ± 10.6 和-16.9 ± 17.0/-9.4 ± 10.6 mmHg。清晨和傍晚的家庭脉搏率也分别显著降低（p < 0.0001），分别为-3.5 ± 7.8 和-3.5 ± 7.3 次/分钟。在基线时，ME 平均值≥135 mmHg 且 ME 差值≥15 mmHg（定义为清晨为主的高血压）的患者占研究人群的 20.4%。然而，在研究结束时，这样的患者数量显著减少到 7.9%（p < 0.0001）。ME 平均值≥135 mmHg 且 ME 差值<15 mmHg（定义为持续性高血压）的患者在基线时占研究人群的 71.1%。这一比例在研究结束时显著降低至 42.8%（p < 0.0001）。ME 平均值从 153.8 ± 15.5 mmHg 显著下降至 135.6 ± 11.9 mmHg，ME 差值也从 6.7 ± 13.1 mmHg 显著下降至 4.7 ± 10.8 mmHg（均 p < 0.0001）。