Prof Morris J Brown F*** a b , Prof Gordon T McInnes FRCP b c, Cheraz Cherif Papst PhD d, Jack Zhang MD d, Prof Thomas M MacDonald FRCP b e
Short-term studies have suggested that the use of initial combination therapy for the control of blood pressure improves early effectiveness. We tested whether a combination of aliskiren and amlodipine is superior to each monotherapy in early control of blood pressure without excess of adverse events, and if initial control by monotherapy impairs subsequent control by combination therapy.
We did a double-blind, randomised, parallel-group, superiority trial at 146 primary and secondary care sites in ten countries, with enrolment from Nov 28, 2008, to July 15, 2009. Patients eligible for enrolment had essential hypertension, were aged 18 years or older, and had systolic blood pressure between 150 and 180 mm Hg. Patients were randomly assigned (1:1:2) to treatment with 150 mg aliskiren plus placebo, 5 mg amlodipine plus placebo, or 150 mg aliskiren plus 5 mg amlodipine. Random assignment was through a central interactive voice response system and treatment allocation was masked from the patients. From 16—32 weeks, all patients received combination therapy with 300 mg aliskiren plus 10 mg amlodipine. Our primary endpoints, assessed on an intention-to-treat basis (ie, in patients who received the allocated treatment), were the adjusted mean reduction in systolic blood pressure from baseline over 8 to 24 weeks, and then the final reduction at 24 weeks. This trial is registered with ClinicalTrials.gov, number NCT00797862.
318 patients were randomly assigned to aliskiren, 316 to amlodipine, and 620 to aliskiren plus amlodipine. 315 patients initially allocated to aliskiren, 315 allocated to amlodipine, and 617 allocated to aliskiren plus amlodipine were available for analysis. Patients given initial combination therapy had a 6·5 mm Hg (95% CI 5·3 to 7·7) greater reduction in mean systolic blood pressure than the monotherapy groups (p<0·0001). At 24 weeks, when all patients were on combination treatment, the difference was 1·4 mm Hg (95% CI ?0·05 to 2·9; p=0·059). Adverse events caused withdrawal of 85 patients (14%) from the initial aliskiren plus amlodipine group, 45 (14%) from the aliskiren group, and 58 (18%) from the amlodipine group. Adverse events were peripheral oedema, hypotension, or orthostatic hypotension.
We believe that routine initial reduction in blood pressure (>150 mm Hg) with a combination such as aliskiren plus amlodipine can be recommended.
Novartis Pharma AG. 苯那普利与氨氯地平合用治疗肾性高血压的疗效分析 2004年第2...【摘要】 目的 探讨肾性高血压患者的血压波动规律及降血压药的选择方法 应用24h动态... (2)联合应用苯那普利和氨氯地平可有效地控制患者24h血压水平,降低患者靶器官损害的危...www.39kf.com/...22-99453.shtml-2005-09-22-快照-氨氯地平合用治疗肾性高血压的疗效分析 2004年第2..." 氨氯地平疗法将降低血压,使高血压患者患新发糖尿病的几率减少超...阻滞剂为基础的抗高血压疗法相比,以钙通道阻滞剂氨氯地平 (amlodipine) 为基础的高血... poulter教授说:“这一数据突出了β阻滞剂合用或不合用利尿剂疗法使患者患新发糖尿病的...www.jttop.com/...19434-2.shtml-2006-12-03-快照-氨氯地平疗法将降低血压,使高血压患者患新发糖尿病的几率减少超..." 医药、生物制品文件类型:PDF/Adobe Acrobat- 文字版600849 上海医药 中性 600812 华北制药 中性 000989 九芝堂 中性 行业内跟踪公司... 3 沙美特罗/氟替卡松丙酸酯 45.04 葛兰素史克 哮喘 4 氨氯地平 44.63 辉瑞 高血压 ...www.p5w.net/...03024373357.pdf-2011-01-08-医药、生物制品"[标签:content2]
作者:admin@医学,生命科学 2011-02-16 00:15