Aliskiren combined with losartan in type 2 diabetes and nephropathy
Aliskiren combined with losartan in type 2 diabetes and nephropathy
复制标题
DOI：
10.1056/nejmoa0708379
复制
发表时间：
2008-06-05
影响因子：
158.5
通讯作者：
Hollenberg, Norman K.
中科院分区：
文献类型：
--
作者：
Parving, Hans-Henrik;Persson, Frederik;Hollenberg, Norman K.
背景：糖尿病肾病是发达国家终末期肾病的主要原因。我们评估了双重阻断的肾素-血管紧张素-醛固酮系统的肾脏保护作用，通过添加治疗阿利吉仑，口服直接的肾素抑制剂，治疗与最大推荐剂量的氯沙坦（100毫克，每天）和最佳的降压治疗的患者谁有高血压和2型糖尿病肾病nephropathy.Methods：我们招募了599例患者在这个多国，随机，双盲研究。在为期3个月的开放标签导入期后，患者每天接受100 mg氯沙坦，患者被随机分配接受6个月的阿利吉仑治疗（每天150 mg，持续3个月，然后将剂量增加到每天300 mg，持续3个月）或安慰剂，除氯沙坦外。主要结果是减少白蛋白与肌酐的比例，在清晨尿样测量，在6 months.Results：两组的基线特征相似。与安慰剂相比，每天服用300 mg阿利吉仑可使平均尿白蛋白/肌酐比值降低20%（95%置信区间，9 - 30; P
Background: Diabetic nephropathy is the leading cause of end-stage renal disease in developed countries. We evaluated the renoprotective effects of dual blockade of the renin-angiotensin-aldosterone system by adding treatment with aliskiren, an oral direct renin inhibitor, to treatment with the maximal recommended dose of losartan (100 mg daily) and optimal antihypertensive therapy in patients who had hypertension and type 2 diabetes with nephropathy.Methods: We enrolled 599 patients in this multinational, randomized, double-blind study. After a 3-month, open-label, run-in period during which patients received 100 mg of losartan daily, patients were randomly assigned to receive 6 months of treatment with aliskiren (150 mg daily for 3 months, followed by an increase in dosage to 300 mg daily for another 3 months) or placebo, in addition to losartan. The primary outcome was a reduction in the ratio of albumin to creatinine, as measured in an early-morning urine sample, at 6 months.Results: The baseline characteristics of the two groups were similar. Treatment with 300 mg of aliskiren daily, as compared with placebo, reduced the mean urinary albumin-to-creatinine ratio by 20% (95% confidence interval, 9 to 30; P