Leonetti G
Unit of Cardiological Rehabilitation and Cardiovascular Diseases, IRCSS, Istituto Auxologico Italiano, S. Luca Hospital, Milan, Italy.
Curr Med Res Opin. 2005 Jun;21(6):951-8. doi: 10.1185/030079905X48438.
This double blind, prospective, randomised, parallel group clinical trial was aimed at investigating the effects of nilvadipine or amlodipine in mild to moderate hypertensive patients over a 3-month treatment period.
Eligible outpatients (supine DBP > or = 90 mmHg and < or = 110 mmHg and supine SBP < or = 180 mmHg) entered a maximum 15-day placebo run-in period and were randomised to receive once daily nilvadipine 8 mg or amlodipine 5 mg (to be doubled in the case of lack of response at day 30). Follow-up visits with measurement of supine and orthostatic blood pressure and heart rate were performed after 15, 30, 60 and 90 days of treatment. Standard laboratory tests and 12-lead ECG were performed at study entry and at the end of treatment; adverse events were collected at any time.
A total number of 168 patients, 83 in the nilvadipine and 85 in the amlodipine group, took part in the study: 15 and 14 in the two groups, respectively, were prematurely withdrawn. Supine DBP at endpoint similarly decreases in the two groups (-11.0 +/- 7.1 mmHg in the nilvadipine group and -12.7 +/- 8.2 mmHg in the amlodipine group), with no significant differences between groups at any time point. Measurements in the orthostatic position also did not show between-groups differences. Blood pressure was normalised in 61.8% of patients in the nilvadipine group and in 63.0% in the amlodipine group; responders to therapy were 64.5% and 69.1% in the two groups, respectively. Results of SBP also did not show differences between groups at any time point, except a more marked decrease in the amlodipine group compared to nilvadipine in the supine measurements at endpoint. A total number of 30 patients (36.6%) in the nilvadipine group and 23 (27.1%) in the amlodipine group reported adverse events (p = 0.24 between groups), which mainly consisted of vasodilatory effects (e.g. oedema, flushing and headache). A favourable lipid profile, i.e. a significant (p = 0.002 between groups) decrease of triglycerides levels and an increase of HDL-C, was observed in the nilvadipine group, compared with an increase of triglycerides in the amlodipine group. No effects on haematology, liver and renal function were observed in either group.
Nilvadipine or amlodipine produced comparable effects on DBP and shared a similar adverse effect profile. A favourable effect on lipid profile was observed following nilvadipine treatment.
本双盲、前瞻性、随机、平行组临床试验旨在研究尼伐地平或氨氯地平对轻度至中度高血压患者3个月治疗期的影响。
符合条件的门诊患者（仰卧位舒张压≥90 mmHg且≤110 mmHg，仰卧位收缩压≤180 mmHg）进入最长15天的安慰剂导入期，然后随机分组，每天服用一次8 mg尼伐地平或5 mg氨氯地平（如30天时无反应则剂量加倍）。治疗15、30、60和90天后进行随访，测量仰卧位和直立位血压及心率。研究开始时和治疗结束时进行标准实验室检查和12导联心电图检查；随时收集不良事件。
共有168例患者参与研究，尼伐地平组83例，氨氯地平组85例：两组分别有15例和14例提前退出。两组终点时仰卧位舒张压均有相似程度下降（尼伐地平组为-11.0±7.1 mmHg，氨氯地平组为-12.7±8.2 mmHg），各时间点两组间无显著差异。直立位测量结果也未显示组间差异。尼伐地平组61.8%的患者血压恢复正常，氨氯地平组为63.0%；两组治疗有效者分别为64.5%和69.1%。收缩压结果在各时间点也未显示组间差异，只是终点时仰卧位测量中氨氯地平组收缩压下降比尼伐地平组更明显。尼伐地平组共有30例患者（36.6%）、氨氯地平组有23例患者（27.1%）报告了不良事件（两组间p = 0.24），主要为血管舒张作用（如水肿、潮红和头痛）。与氨氯地平组甘油三酯升高相比，尼伐地平组观察到有利的血脂谱，即甘油三酯水平显著下降（两组间p = 0.002）且高密度脂蛋白胆固醇升高。两组对血液学、肝肾功能均无影响。
尼伐地平或氨氯地平对舒张压产生相似作用，不良反应谱相似。尼伐地平治疗后对血脂谱有有利影响。
