Efficacy and safety of combined use of aliskiren and valsartan in patients with hypertension: a randomised, double-blind trial
Efficacy and safety of combined use of aliskiren and valsartan in patients with hypertension: a randomised, double-blind trial
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DOI：
10.1016/s0140-6736(07)61124-6
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发表时间：
2007-07-21
期刊：
影响因子：
168.9
通讯作者：
Satlin, Andrew
中科院分区：
文献类型：
--
作者：
Oparil, Suzanne;Yarows, Steven A.;Satlin, Andrew
背景：本研究的目的是评估在高血压患者中使用阿利吉伦和valsartan的最大推荐剂量的双重肾素系统干预，并与每种药物单独使用进行比较。方法在这项双盲研究中，1797例高血压患者(平均坐位舒张压95-109 mm)。HG和8h日间动态舒张压90 mm。HG)被随机分配，每天服用一次阿利吉伦150 mg(n=437)，valsartan 160环(455)，阿利吉伦150 mg和valsartan 160 mg(446)，或安慰剂(459)，持续4周，然后强制滴定，使剂量增加一倍，达到最大推荐剂量，再持续4周。主要终点是从基线到第8周终点的平均坐位舒张压的变化。根据治疗意向进行分析。这项试验已在临床试验中注册。GOV，编号NCT00219180。发现196名(11%)患者在试验结束前停止研究治疗(安慰剂组63例，阿利吉仑组53例，valsartan组43例，aliskiren/valsartan组37例)，主要原因是缺乏治疗效果。在第8周的终点，阿利吉伦300毫克和valsartan 320 mg的联合用药使平均坐位舒张压比基线降低了12.2毫米汞柱，比单一治疗(阿利吉伦300毫克9毫米汞降低，p<；0.0001；valsartan 320 mg，9.7毫米汞降低，p<；0.0001)或安慰剂(4.1毫米汞降低，p<；0.0001)要大得多。所有组的不良事件和实验室异常的发生率都是相似的。解释说，在推荐的最大剂量下，阿利吉伦和valsartan联合治疗高血压患者的降压效果比单独使用这两种药物的效果要大得多，耐受性与单独使用aliskiren和valsartan相似。
Background The aim of this study was to assess dual renin system intervention with the maximum recommended doses of aliskiren and valsartan, compared with each drug alone in patients with hypertension.Methods In this double-blind study, 1797 patients with hypertension (mean sitting diastolic blood pressure 95-109 mm. Hg and 8-h daytime ambulatory diastolic blood pressure 90 mm. Hg) were randomly assigned to receive once-daily aliskiren 150 mg (n=437), valsartan 160 ring (455), a combination of aliskiren 150 mg and valsartan 160 mg (446), or placebo (459) for 4 weeks, followed by forced titration to double the dose to the maximum recommended dose for another 4 weeks. The primary endpoint was change in mean sitting diastolic blood pressure from baseline to week 8 endpoint. Analyses were done by intention to treat. This trial is registered at ClinicalTrials. gov with the number NCT00219180.Findings 196 (11%) patients discontinued study treatment before the end of the trial (63 in the placebo group, 53 in the aliskiren group, 43 in the valsartan group, and 37 in the aliskiren/valsartan group), mainly due to lack of therapeutic effect. At week 8 endpoint, the combination of aliskiren 300 mg and valsartan 320 mg lowered mean sitting diastolic blood pressure from baseline by 12.2 mm Hg, significantly more than either monotherapy (aliskiren 300 mg 9.0 mm Hg decrease, p < 0.0001; valsartan 320 mg, 9.7 mm Hg decrease, p < 0.0001), or with placebo (4.1 mm Hg decrease, p < 0.0001). Rates of adverse events and laboratory abnormalities were similar in all groups.Interpretation The combination of aliskiren and valsartan at maximum recommended doses provides significantly greater reductions in blood pressure than does monotherapy with either agent in patients with hypertension, with a tolerability profile similar to that with aliskiren and valsartan alone.