Littlejohn Thomas W, Trenkwalder Peter, Hollanders Geert, Zhao Yanxing, Liao Weichi
Piedmont Medical Research Associates, Winston-Salem, NC 27103, USA.
Curr Med Res Opin. 2009 Apr;25(4):951-9. doi: 10.1185/03007990902785845.
Most patients with hypertension require antihypertensive combination therapy to achieve BP control. This study investigated the safety and efficacy of the direct renin inhibitor aliskiren combined with the calcium channel blocker amlodipine.
Overall, 556 patients with hypertension (msDBP > or =95-<110 mmHg) received open-label aliskiren/amlodipine 150/5 mg for 2 weeks, followed by forced titration to aliskiren/amlodipine 300/10 mg for 52 weeks. Add-on hydrochlorothiazide (HCT) was permitted from week 10 to achieve BP control (<140/90 mmHg). The primary objective of the study was to evaluate the long-term safety and tolerability of aliskiren/amlodipine combination therapy; the BP-lowering efficacy of the combination was also assessed (week 54 endpoint; last observation carried forward).
ClinicalTrials.gov identifier NCT00402103.
In total, 452 patients completed 54 weeks' treatment with aliskiren/amlodipine 300/10 mg, with or without add-on HCT. The most frequently reported adverse events (AEs) were peripheral edema, upper respiratory tract infection, headache and bronchitis. Peripheral edema (the most common AE), occurred in 22.7% of treated patients, and was generally mild or moderate in intensity and transient in nature. Few patients exhibited laboratory abnormalities. Aliskiren/amlodipine combination therapy provided a mean BP reduction from baseline to week 54 of 24.2/15.5 mmHg; 74.3% of patients achieved BP control. In the subgroup of patients with stage 2 hypertension (baseline msSBP > or =160 mmHg and/or msDBP > or =100 mmHg), the mean BP reduction at week 54 was 29.1/17.1 mmHg, and 67.0% of patients achieved BP control.
In this open-label study, aliskiren/amlodipine 300/10 mg combination therapy, with or without add-on HCT, effectively reduced BP, particularly in patients with stage 2 hypertension. The most common AE was peripheral edema, consistent with the known AE profile of high-dose (10 mg) amlodipine. Further studies comparing the aliskiren/amlodipine combination with the component monotherapies and other antihypertensive combinations are warranted.
大多数高血压患者需要联合使用抗高血压药物来控制血压。本研究调查了直接肾素抑制剂阿利吉仑与钙通道阻滞剂氨氯地平联合使用的安全性和有效性。
总共556例高血压患者（平均坐位舒张压[msDBP]≥95-<110 mmHg）接受了为期2周的开放标签阿利吉仑/氨氯地平150/5 mg治疗，随后强制滴定至阿利吉仑/氨氯地平300/10 mg并持续52周。从第10周开始允许加用氢氯噻嗪（HCT）以实现血压控制（<140/90 mmHg）。该研究的主要目的是评估阿利吉仑/氨氯地平联合治疗的长期安全性和耐受性；还评估了联合用药的降压疗效（第54周终点；末次观察结转）。
ClinicalTrials.gov标识符NCT00402103。
总共452例患者完成了阿利吉仑/氨氯地平300/10 mg的54周治疗，无论是否加用HCT。最常报告的不良事件（AE）为外周水肿、上呼吸道感染、头痛和支气管炎。外周水肿（最常见的AE）发生在22.7%的治疗患者中，强度一般为轻度或中度，且为一过性。很少有患者出现实验室异常。阿利吉仑/氨氯地平联合治疗使平均血压从基线到第54周降低了24.2/15.5 mmHg；74.3%的患者实现了血压控制。在2级高血压患者亚组（基线平均坐位收缩压[msSBP]≥160 mmHg和/或msDBP≥100 mmHg）中，第54周时平均血压降低29.1/17.1 mmHg，67.0%的患者实现了血压控制。
在这项开放标签研究中，阿利吉仑/氨氯地平300/10 mg联合治疗，无论是否加用HCT，均能有效降低血压，尤其是在2级高血压患者中。最常见的AE是外周水肿，与高剂量（10 mg）氨氯地平已知的AE情况一致。有必要进一步开展研究，比较阿利吉仑/氨氯地平联合用药与单药治疗以及其他抗高血压联合用药的效果。
