Comparative efficacy and safety of aliskiren, an oral direct renin inhibitor, and ramipril in hypertension: a 6-month, randomized, double-blind trial
Comparative efficacy and safety of aliskiren, an oral direct renin inhibitor, and ramipril in hypertension: a 6-month, randomized, double-blind trial
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DOI：
10.1097/hjh.0b013e3282f3ad9a
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发表时间：
2008-03-01
影响因子：
4.9
通讯作者：
Keefe, Deborah L.
中科院分区：
文献类型：
--
作者：
Andersen, Karl;Weinberger, Myron H.;Keefe, Deborah L.
目的本双盲研究比较了口服直接肾素抑制剂阿利吉仑和血管紧张素转换酶抑制剂雷米普利单用和联合氢氯噻嗪治疗高血压患者的长期疗效、安全性和耐受性。842例患者[平均坐位舒张压（msDBP）95-109 mmHg]随机接受阿利吉仑150 mg（n = 420）或雷米普利5 mg（n = 422）。在第6、12、18和21周允许剂量滴定（阿利吉仑300 mg/雷米普利10 mg）和随后的氢氯噻嗪添加（12.5 mg，如果需要，滴定至25 mg），以控制血压不充分。完成26周的活性对照治疗期的患者被重新随机分配到他们现有的方案或安慰剂为4周的双盲withdrawal phase.Results六百八十七例（81.6%）完成了积极的治疗期。在第26周时，阿利吉仑为基础的治疗使平均坐位收缩压（17.9 vs 15.2 mmHg，P= 0.0036）和msDBP（13.2 vs 12.0 mmHg，P=0.025）的平均降低幅度更大，收缩压控制率更高（
Objectives This double-blind study compared long-term efficacy, safety and tolerability of the oral direct renin inhibitor aliskiren and the angiotensin-converting enzyme inhibitor ramipril alone and combined with hydrochlorothiazide in patients with hypertension.Methods After a 2-4-week placebo run-in, 842 patients [mean sitting diastolic blood pressure (msDBP) 95-109 mmHg] were randomized to aliskiren 150 mg (n = 420) or ramipril 5 mg (n = 422). Dose titration (to aliskiren 300 mg/ramipril 10 mg) and subsequent hydrochlorothiazide addition (12.5 mg, titrated to 25 mg if required) were permitted at weeks 6, 12, 18 and 21 for inadequate blood pressure control. Patients completing the 26-week active-controlled treatment period were re-randomized to their existing regimen or placebo for a 4-week double-blind withdrawal phase.Results Six hundred and eighty-seven patients (81.6%) completed the active treatment period. At week 26, aliskiren-based therapy produced greater mean reductions in mean sitting systolic blood pressure (17.9 versus 15.2 mmHg, P= 0.0036) and msDBP (13.2 versus 12.0mmHg, P=0.025), and higher rates of systolic blood pressure control (