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氯沙坦与糖尿病肾病

Losartan in diabetic nephropathy.

作者信息

Carswell Christopher I, Goa Karen L

机构信息

Adis International Limited, Auckland, New Zealand.

出版信息

Drugs. 2003;63(4):407-14; discussion 415-6. doi: 10.2165/00003495-200363040-00006.

Abstract

Losartan is an orally active, selective, nonpeptide, angiotensin II AT(1) receptor antagonist. Losartan 50 or 100 mg/day was significantly more effective than placebo in reducing the incidence of a doubling of serum creatinine, end-stage renal disease (ESRD) or death (43.5% vs 47.1%, p = 0.02) in a pivotal, well designed trial (Reduction of Endpoints in Non insulin dependent diabetes mellitus with the Angiotensin II Antagonist Losartan [RENAAL] study) in 1513 patients with type 2 diabetes mellitus and proteinuria. Losartan also significantly reduced the incidence of doubling of serum creatinine level (p = 0.006), ESRD (p = 0.002), ESRD or death (p = 0.01) and doubling of serum creatinine and ESRD (p = 0.01) compared with placebo in the RENAAL trial. There were similar incidences of overall mortality and morbidity and mortality from cardiovascular causes between treatment groups. In addition, data from several nonblind and double-blind studies indicates that losartan effectively reduces the mean albumin excretion rate. Two double-blind studies show that losartan has similar effects to enalapril on kidney function. Data from 4058 patients (3300 with essential hypertension) who have received losartan (10-150 mg/day) in clinical trials indicate it is well tolerated. In the RENAAL study 17.2% and 21.7% of losartan and placebo recipients discontinued treatment because of adverse events, but causality was not determined.

摘要

氯沙坦是一种口服活性、选择性、非肽类血管紧张素II AT(1)受体拮抗剂。在一项针对1513例2型糖尿病伴蛋白尿患者的关键、设计良好的试验(用血管紧张素II拮抗剂氯沙坦降低非胰岛素依赖型糖尿病终点事件[RENAAL]研究)中,氯沙坦50或100mg/天在降低血清肌酐翻倍、终末期肾病(ESRD)或死亡发生率方面显著优于安慰剂(43.5%对47.1%,p = 0.02)。在RENAAL试验中,与安慰剂相比,氯沙坦还显著降低了血清肌酐水平翻倍的发生率(p = 0.006)、ESRD发生率(p = 0.002)、ESRD或死亡发生率(p = 0.01)以及血清肌酐翻倍和ESRD发生率(p = 0.01)。各治疗组之间的总死亡率、发病率以及心血管原因导致的死亡率发生率相似。此外,多项非盲法和双盲法研究的数据表明,氯沙坦能有效降低平均白蛋白排泄率。两项双盲研究表明,氯沙坦在肾功能方面与依那普利有相似的作用。在临床试验中接受氯沙坦(10 - 150mg/天)的4058例患者(3300例原发性高血压患者)的数据表明其耐受性良好。在RENAAL研究中,分别有17.2%和21.7%的氯沙坦和安慰剂接受者因不良事件而停药,但未确定因果关系。

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