Lins Robert, De Vries Caroline
Department of Internal Medicine, University of Antwerp, Antwerp, Belgium.
Astellas Pharma B.V., Leiden, The Netherlands.
Open Cardiovasc Med J. 2017 Nov 17;11:120-132. doi: 10.2174/1874192401711010120. eCollection 2017.
The aim of this study was to compare the efficacy and tolerability of barnidipine, a strong lipophilic calcium channel blocker, in younger (≤55 for efficacy or <65 years for adverse events) versus older (>55 or ≥65 years) patients with uncomplicated hypertension.
20,275 patients received barnidipine, 10 or 20 mg/day, as monotherapy or in combination with other antihypertensive drug(s) in the observational BArnidipine real-life Safety and tolerability In Chronic HyperTension (BASIC-HT) study. Efficacy and tolerability were assessed over a 3-month period. The present paper describes results from prespecified subgroup analyses by age not reported elsewhere.
Both age groups showed a clinically meaningful decrease in blood pressure (BP) over time (p<0.0001). The mean systolic and diastolic BP after approximately 3 months of barnidipine therapy was well below the target value of <140/90 mmHg for individual patients, with no notable differences between age groups. The decrease in mean pulse pressure was greater in patients >55 years (-10.8 mmHg) than in patients ≤55 years (-8.7 mmHg) (p<0.0001) and the proportion of patients with pulse pressure >60 mmHg decreased from 61.1% at baseline to 24.8% at Visit 3 in patients >55 years and from 47.7% to 16.5% in patients ≤55 years (p<0.0001).The overall incidence of adverse events was low, leading to treatment discontinuation in only 3.0-3.6% of patients. Peripheral edema, a common adverse effect with calcium channel blockers in clinical practice, was reported by 2.7% of patients aged <65 years and by 4.6% of patients aged ≥65 years.
The efficacy and tolerability profiles of barnidipine as monotherapy or in combination with other antihypertensive drugs were shown to be favorable in both younger and older patients in a real-life practice setting. Randomized double-blind controlled studies are needed to confirm these results.
本研究旨在比较强效亲脂性钙通道阻滞剂巴尼地平在较年轻患者（疗效评估年龄≤55岁或不良事件评估年龄<65岁）与较年长患者（>55岁或≥65岁）的单纯性高血压患者中的疗效和耐受性。
在观察性巴尼地平慢性高血压真实生活安全性和耐受性（BASIC-HT）研究中，20275例患者接受巴尼地平治疗，剂量为每日10或20毫克，作为单一疗法或与其他抗高血压药物联合使用。在3个月的时间内评估疗效和耐受性。本文描述了按年龄进行的预先指定亚组分析的结果，这些结果在其他地方未报告。
两个年龄组的血压（BP）均随时间出现具有临床意义的下降（p<0.0001）。巴尼地平治疗约3个月后的平均收缩压和舒张压远低于个体患者的目标值<140/90 mmHg，年龄组之间无显著差异。>55岁患者的平均脉压下降幅度（-10.8 mmHg）大于≤55岁患者（-8.7 mmHg）（p<0.0001），脉压>60 mmHg的患者比例在>55岁患者中从基线时的61.1%降至第3次访视时的24.8%，在≤55岁患者中从47.7%降至16.5%（p<0.0001）。不良事件的总体发生率较低，仅3.0-3.6%的患者因不良事件停药。外周水肿是临床实践中钙通道阻滞剂常见的不良反应，<65岁患者中有2.7%报告出现外周水肿，≥65岁患者中有4.6%报告出现外周水肿。
在现实生活实践中，巴尼地平作为单一疗法或与其他抗高血压药物联合使用时，在较年轻和较年长患者中均显示出良好的疗效和耐受性。需要进行随机双盲对照研究来证实这些结果。
