Chalmers J, Castaigne A, Morgan T, Chastang C
University of Sydney, Royal North Shore Hospital, St. Leonards, New South Wales, Australia.
J Hypertens. 2000 Mar;18(3):327-37. doi: 10.1097/00004872-200018030-00013.
To determine the long-term efficacy and safety of a fixed, very-low-dose tablet combining one-half the standard dose of perindopril with one-quarter the standard dose of indapamide as first-line treatment in elderly patients.
Double-blind, randomized, placebo-controlled study in an outpatient setting.
Following a single-blind, placebo run-in period of 4 weeks, patients [65-85 years, with mild-to-moderate essential hypertension or isolated systolic hypertension (ISH)] were randomized to receive one tablet of perindopril 2 mg/indapamide 0.625 mg (Per/ Ind) (n=193) or placebo (n=190), daily for 12 weeks. After this first 12-week period, all patients on Per/Ind (n=138) and patients responding to placebo (n=61) were maintained on their previous regimen for a further 48 weeks. Patients in the placebo group whose blood pressure was not normalized, were switched to Per/Ind (n=60).
The primary endpoint was the proportion of patients with blood pressure that normalized between weeks 0 and 60.
After 1 year of treatment (intention-to-treat) supine systolic and diastolic blood pressure decreased by 23.0 +/- 15.3 mmHg and 13.3 +/- 94 mmHg with Per/Ind (n=253: 193 from randomized Per/Ind group and 60 from the placebo group switched at week 12). The mean decreases in systolic blood pressure were similar in essential hypertension and ISH (systolic blood pressure 23.2 versus 22.7 mmHg, respectively). Per/Ind treatment (n=253) achieved an initial normalization of blood pressure in 96.2% [95% confidence interval (CI) 93.6-98.9%; Kaplan-Meier estimate] of Per/Ind-treated patients; 79.8% (95% CI 74.1-85.5%) of these maintained a normalized blood pressure throughout the 1 -year follow-up. The incidence of adverse events was similarly low in the placebo and active therapy groups. Efficacy and safety results for the over 75 years subgroup were similar to those for the younger elderly subjects
The fixed, very low-dose combination of perindopril 2 mg/indapamide 0.625 mg results in sustained blood pressure control when used as first line treatment of elderly hypertensive patients over 1-year, and is well-tolerated.
确定一种固定的极低剂量片剂（将培哚普利标准剂量的一半与吲达帕胺标准剂量的四分之一相结合）作为老年患者一线治疗的长期疗效和安全性。
门诊环境下的双盲、随机、安慰剂对照研究。
经过4周的单盲、安慰剂导入期后，患者[年龄65 - 85岁，患有轻度至中度原发性高血压或单纯收缩期高血压（ISH）]被随机分配，每天服用一片培哚普利2毫克/吲达帕胺0.625毫克（培哚普利/吲达帕胺）（n = 193）或安慰剂（n = 190），持续12周。在这第一个12周期间之后，所有服用培哚普利/吲达帕胺的患者（n = 138）和对安慰剂有反应的患者（n = 61）继续使用之前的治疗方案再持续48周。安慰剂组中血压未恢复正常的患者改为服用培哚普利/吲达帕胺（n = 60）。
主要终点是在第0周至第60周期间血压恢复正常的患者比例。
经过1年治疗（意向性分析），服用培哚普利/吲达帕胺（n = 253：193名来自随机分组的培哚普利/吲达帕胺组，60名来自第12周时从安慰剂组转换过来的患者）后，仰卧位收缩压和舒张压分别下降了23.0±15.3毫米汞柱和13.3±9.4毫米汞柱。原发性高血压和ISH患者的收缩压平均下降幅度相似（收缩压分别为23.2毫米汞柱和22.7毫米汞柱）。培哚普利/吲达帕胺治疗（n = 253）使96.2%[95%置信区间（CI）93.6 - 98.9%；Kaplan - Meier估计值]的服用培哚普利/吲达帕胺治疗的患者血压初步恢复正常；其中79.8%（95%CI 74.1 - 85.5%）的患者在1年随访期间血压一直保持正常。安慰剂组和活性治疗组的不良事件发生率同样较低。75岁以上亚组的疗效和安全性结果与年轻老年受试者相似。
当作为老年高血压患者的一线治疗用药时，固定的极低剂量组合培哚普利2毫克/吲达帕胺0.625毫克可实现1年以上持续的血压控制，且耐受性良好。
