Skibitskiy V V, Fendrikova A V, Sirotenko D V, Skibitskiy A V
Kuban State Medical University, Hospital Therapy Department, Krasnodar, Russia.
Kardiologiia. 2016 Oct;56(10):35-40. doi: 10.18565/cardio.2016.10.35-40.
Determination of the effectiveness and safety of different dosing regimens during the day (in the morning or at bedtime) combination therapy including azilsartan medoxomil in patients with essential hypertension and metabolic syndrome (MS).
The study included 60 patients with uncontrolled hypertension and MS (age median - 59 (54-65) years). Patients were randomized in two groups: group 1 (n=30) received azilsartan medoxomil 40 mg/day, and indapamide retard 1,5 mg/day in the morning; group 2 (n=30)- azilsartan medoxomoil 40 mg at bedtime and indapamide retard 1,5 mg in the morning. All patients at baseline, and after 4 and 12weeks assessed levels of office blood pressure (BP), heart rate (HR); at baseline and after 12 weeks was conducted ambulatory BPmonitoring (ABPM). Evaluated the main indicators of circadian blood pressure profile, as well as the central aortic pressure (CAP) and the rigidity of the vascular wall: systolic, diastolic, and mean arterial pressure in the aorta, aortic augmentation index, pulse wave velocity in the aorta, the augmentation index. Study results were processed using the program Statistica 6.1 by methods nonparametric statistics.
Regardless of the regimen used azilsartan destination as part of combination therapy after 4 weeks showed a significant (p<0.05) reduction in SBP and DBP. After 12 weeks of observation target blood pressure was recorded 27 (90%) patients of group 1 and 29 (96.7%)- group2. As a result of ABPM after 12 weeks of treatment in both groups showed a statistically significant (p<0.05) improvement in all parameters investigated. However, positive changes such indicators as an index time of hypertension in the day and night hours, SBP, DBP, and BP variability during the night, the morning rise of systolic as well as the speed of morning rise in SBP and DBP were more pronounced in the appointment azilsartan medoxomil at bedtime compared to morning reception. The use of both treatment regimens provided significant (p<0.05) increase frequency registration profile dippear and reduction - non-dipper. Importantly, irrespective of the time of taking the drugs in both groups occurred significant (p <0.05), and a comparable improvement in rigidity and CAP vascular wall.
When combined with essential hypertension and MS azilsartana use of combination drug therapy provided achievement of the target values of blood pressure in the majority of patients, a significant improvement in the main indicators of ABPM, CAP, and the rigidity of the vascular wall, as well as the normalization of daily profile of blood pressure in the majority of patients, regardless of dosing regimen during the day. However, the combination of indapamide retard morning - azilsartan medoxomil at bedtime accompanied by a significantly greater positive changes most ABPM parameters, especially at night.
确定在患有原发性高血压和代谢综合征（MS）的患者中，一天中不同给药方案（早晨或睡前）联合使用阿齐沙坦美洛昔酯的有效性和安全性。
该研究纳入了60例高血压未得到控制且患有MS的患者（年龄中位数为59（54 - 65）岁）。患者被随机分为两组：第1组（n = 30）早晨服用阿齐沙坦美洛昔酯40 mg/天和吲达帕胺缓释片1.5 mg/天；第2组（n = 30）睡前服用阿齐沙坦美洛昔酯40 mg，早晨服用吲达帕胺缓释片1.5 mg。所有患者在基线时、4周和12周后评估诊室血压（BP）、心率（HR）水平；在基线时和12周后进行动态血压监测（ABPM）。评估昼夜血压模式的主要指标，以及中心主动脉压（CAP）和血管壁硬度：主动脉的收缩压、舒张压和平均动脉压、主动脉增强指数、主动脉脉搏波速度、增强指数。研究结果使用Statistica 6.1程序通过非参数统计方法进行处理。
无论使用何种方案，作为联合治疗一部分的阿齐沙坦在4周后均显示收缩压和舒张压显著（p < 0.05）降低。观察12周后，第1组27例（90%）患者和第2组29例（96.7%）患者达到目标血压。两组治疗12周后的ABPM结果显示，所有研究参数均有统计学显著（p < 0.05）改善。然而，与早晨服用相比，睡前服用阿齐沙坦美洛昔酯时，诸如白天和夜间高血压指数时间、收缩压、舒张压以及夜间血压变异性、收缩压早晨升高以及收缩压和舒张压早晨升高速度等指标的积极变化更为明显。两种治疗方案的使用均使血压下降曲线呈勺型的频率显著（p < 0.05）增加，非勺型频率降低。重要的是，无论两组服药时间如何，血管壁硬度和CAP均有显著（p < 0.05）且相当的改善。
在原发性高血压和MS患者中联合使用阿齐沙坦时，联合药物治疗可使大多数患者达到血压目标值，显著改善ABPM、CAP和血管壁硬度的主要指标，以及大多数患者的血压日模式正常化，无论一天中的给药方案如何。然而，早晨服用吲达帕胺缓释片 - 睡前服用阿齐沙坦美洛昔酯的联合用药伴随着大多数ABPM参数更显著的积极变化，尤其是在夜间。
