Unité de Recherche Sur L'hypertension, Centre Hospitalier Universitaire de Québec (CHUL), Quebec, Quebec, Canada.
J Hypertens. 2012 Oct;30(10):2047-55. doi: 10.1097/HJH.0b013e328356b8ea.
To evaluate the clinic and ambulatory blood pressure (BP)-lowering efficacy and safety of an aliskiren/amlodipine/hydrochlorothiazide (HCT) triple combination compared with the component dual combinations, in patients with moderate-to-severe hypertension.
This 8-week, double-blind, randomized, active-controlled study, after 1-4 weeks single-blind placebo run-in period, randomized 1191 patients to receive once-daily aliskiren/amlodipine 150/5 mg (n = 287), aliskiren/HCT 150/12.5 mg (n = 298), amlodipine/HCT 5/12.5 mg (n = 296), or aliskiren/amlodipine/HCT 150/5/12.5 mg (up-titrated from aliskiren/HCT 150/12.5 mg after initial 3 days) (n = 310) for 4 weeks, followed by forced titration to double the initial dose for the next 4 weeks.
Baseline mean sitting SBP and DBP (msSBP/msDBP) was comparable among treatment groups. The aliskiren/amlodipine/HCT combination resulted in significant least squares mean reduction in msSBP/msDBP from baseline to endpoints (week 4, -30.7/-15.9 mmHg; week 8, -37.9/-20.6 mmHg), superior (P < 0.001) to each of the dual combinations. The triple combination was associated with -27.8 mmHg reduction in msSBP at week 2, significantly better than the dual combinations (P < 0.05). Significantly greater mean SBP/DBP-lowering effect for triple vs. dual combinations was also demonstrated through 24-h, daytime, and night-time ambulatory BP measurements. Significantly greater (P < 0.001) BP control (msSBP/msDBP < 140/90 mmHg) was achieved with triple combination in patients with moderate-to-severe (62.3%) and severe (57.5%) hypertension.
Aliskiren/amlodipine/HCT at 150/5/12.5 mg (week 4) and 300/10/25 mg (week 8) provided statistically superior reductions in msSBP/msDBP and greater BP control rates vs. the dual combinations, and was well tolerated. The improved efficacy of BP reduction was evident within 2 weeks of initiating triple therapy even at low dose.
评估阿利吉仑/氨氯地平/氢氯噻嗪（HCT）三联复方与各成分二联复方相比，在中重度高血压患者中的临床和门诊血压（BP）降压疗效和安全性。
这是一项为期 8 周的、双盲、随机、阳性对照研究，在 1-4 周的单盲安慰剂导入期后，将 1191 例患者随机分为每日一次接受阿利吉仑/氨氯地平 150/5mg（n=287）、阿利吉仑/HCT 150/12.5mg（n=298）、氨氯地平/HCT 5/12.5mg（n=296）或阿利吉仑/氨氯地平/HCT 150/5/12.5mg（在最初 3 天起始用阿利吉仑/HCT 150/12.5mg 后上调剂量）（n=310）治疗 4 周，随后在前 4 周内将初始剂量加倍进行强制滴定，之后再治疗 4 周。
治疗组间基线坐位收缩压和舒张压（msSBP/msDBP）的平均值相似。阿利吉仑/氨氯地平/HCT 三联复方治疗从基线到终点时 msSBP/msDBP 的最小均方差显著降低（第 4 周，-30.7/-15.9mmHg；第 8 周，-37.9/-20.6mmHg），优于各二联复方（P＜0.001）。与二联复方相比，三联复方在第 2 周时 msSBP 降低了-27.8mmHg，差异有统计学意义（P＜0.05）。通过 24 小时、白天和夜间动态血压测量，也显示了三联复方对 SBP/DBP 降低的平均效应显著优于二联复方。在中重度（62.3%）和重度（57.5%）高血压患者中，三联复方达到 BP 控制（msSBP/msDBP＜140/90mmHg）的比例显著更高（P＜0.001）。
阿利吉仑/氨氯地平/HCT 150/5/12.5mg（第 4 周）和 300/10/25mg（第 8 周）与各二联复方相比，可显著降低 msSBP/msDBP，BP 控制率更高，且耐受性良好。即使在低剂量下，开始三联治疗后 2 周内即可明显降低血压。
