Alcocer L, Campos C, Bahena J H, Nacaud A, Parra Carillo J, Calvo C, Weber C, Lerebours G, Mickalonis L, Villahermosa M T
Hospital General, Mexico, Mexico.
Cardiovasc Drugs Ther. 1995 Jun;9(3):431-6. doi: 10.1007/BF00879032.
The aim of this 3-month double-blind study was to assess the antihypertensive effect and acceptability of perindopril in comparison with enalapril in patients with mild to moderate essential hypertension. After a 4-week placebo run-in period, 161 patients with supine diastolic blood pressure (DBP) between 95 and 115 mmHg were randomized to receive perindopril 4 mg or enalapril 10 mg once daily. If supine DBP was higher than 90 mmHg, treatment was adjusted monthly, first by doubling the dose and then by addition of hydrochlorothiazide 12.5 mg. After 3 months of active treatment the decrease in supine and standing blood pressures was statistically significant within both groups but was not statistically different between groups. The percentage of patients (65%) who achieved supine DBP of < or = 90 mmHg in the perindopril group was not significantly different from the enalapril group (73%). Monotherapy resulted in control of supine DBP in 56% of the perindopril group and 58% of the enalapril group; the addition of hydrochlorothiazide resulted in control of supine DBP in 6% and 15% respectively. The number of withdrawals for adverse events was statistically significant between groups (0 in the perindopril group and 7 in the enalapril group, p = 0.01). During active treatment the most frequently reported complaints were headaches and cough; there was not statistically difference between groups. Changes in laboratory parameters were minor and not significantly different between the two groups except for serum glucose, potassium, and triglyceride levels. In conclusion, there was no significance between perindopril and enalapril in terms of efficacy. Clinical acceptability seems to be better in the perindopril group.(ABSTRACT TRUNCATED AT 250 WORDS)
这项为期3个月的双盲研究旨在评估培哚普利与依那普利相比,对轻至中度原发性高血压患者的降压效果及可接受性。在为期4周的安慰剂导入期后,161例仰卧位舒张压(DBP)在95至115 mmHg之间的患者被随机分为每日一次接受4 mg培哚普利或10 mg依那普利治疗。如果仰卧位DBP高于90 mmHg,则每月调整治疗,首先将剂量加倍,然后加用12.5 mg氢氯噻嗪。积极治疗3个月后,两组仰卧位和站立位血压下降均有统计学意义,但组间无统计学差异。培哚普利组达到仰卧位DBP≤90 mmHg的患者百分比(65%)与依那普利组(73%)无显著差异。单药治疗使培哚普利组56%、依那普利组58%的患者仰卧位DBP得到控制;加用氢氯噻嗪后,分别使6%和15%的患者仰卧位DBP得到控制。两组因不良事件而退出的人数有统计学差异(培哚普利组为0,依那普利组为7,p = 0.01)。积极治疗期间,最常报告的不适为头痛和咳嗽;组间无统计学差异。实验室参数变化较小,除血糖、钾和甘油三酯水平外,两组间无显著差异。总之,培哚普利和依那普利在疗效方面无显著性差异。培哚普利组的临床可接受性似乎更好。(摘要截短于250字)