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阿利吉仑与氯沙坦治疗非糖尿病慢性肾病的试验

Aliskiren and losartan trial in non-diabetic chronic kidney disease.

作者信息

Woo Keng-Thye, Choong Hui-Lin, Wong Kok-Seng, Tan Han-Kim, Foo Marjorie, Fook-Chong Stephanie, Lee Evan J C, Anantharaman Vathsala, Lee Grace S L, Chan Choong-Meng

机构信息

Department of Renal Medicine, Singapore General Hospital, Singapore

Department of Renal Medicine, Singapore General Hospital, Singapore.

出版信息

J Renin Angiotensin Aldosterone Syst. 2014 Dec;15(4):515-22. doi: 10.1177/1470320313510584. Epub 2014 Apr 17.

Abstract

INTRODUCTION

This is a report of a clinical trial on the therapeutic efficacy and safety of combined aliskiren and losartan (an angiotensin II receptor blocker (ARB)) versus aliskiren alone and ARB alone in non-diabetic chronic kidney disease (CKD) over a 3-year period.

MATERIALS AND METHODS

This was a randomised trial in 155 patients with non-diabetic CKD comparing aliskiren (150 mg/day) (n=52) versus losartan (100 mg/day) (n=52) and the third group aliskiren (150 mg/day) combined with losartan (100 mg/day) (n=51). The trial utilised primary renal end points of eGFR <15 ml/min or end-stage renal failure.

RESULTS

All three groups had significant reduction of proteinuria (p<0.001 for all). The changes in eGFR, total urinary protein from baseline to each year were not significantly different between the three therapeutic groups.

CONCLUSION

This study in non-diabetic CKD patients showed that combination therapy with aliskiren and ARB was as efficacious as aliskiren alone and ARB alone. There was one patient who developed a non-fatal stroke in the combined aliskiren and ARB group while the other two groups had none.

摘要

引言

本文是一项关于阿利吉仑与氯沙坦(一种血管紧张素 II 受体阻滞剂(ARB))联合用药与单独使用阿利吉仑及单独使用 ARB 在非糖尿病慢性肾脏病(CKD)患者中进行的为期 3 年的治疗效果及安全性的临床试验报告。

材料与方法

这是一项针对 155 例非糖尿病 CKD 患者的随机试验,比较阿利吉仑(150 毫克/天)(n = 52)、氯沙坦(100 毫克/天)(n = 52)以及第三组阿利吉仑(150 毫克/天)与氯沙坦(100 毫克/天)联合用药(n = 51)的效果。该试验采用估算肾小球滤过率(eGFR)<15 毫升/分钟或终末期肾衰竭作为主要肾脏终点指标。

结果

所有三组蛋白尿均显著减少(三组 p 值均<0.001)。三组治疗组从基线到每年的 eGFR 及总尿蛋白变化无显著差异。

结论

这项针对非糖尿病 CKD 患者的研究表明,阿利吉仑与 ARB 联合治疗与单独使用阿利吉仑及单独使用 ARB 的疗效相当。在阿利吉仑与 ARB 联合用药组有 1 例患者发生非致命性中风,而其他两组无此情况。

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