Brenner B M, Cooper M E, de Zeeuw D, Keane W F, Mitch W E, Parving H H, Remuzzi G, Snapinn S M, Zhang Z, Shahinfar S
Renal Division, Brigham and Women's Hospital, Boston, MA 02115, USA.
N Engl J Med. 2001 Sep 20;345(12):861-9. doi: 10.1056/NEJMoa011161.
Diabetic nephropathy is the leading cause of end-stage renal disease. Interruption of the renin-angiotensin system slows the progression of renal disease in patients with type 1 diabetes, but similar data are not available for patients with type 2, the most common form of diabetes. We assessed the role of the angiotensin-II-receptor antagonist losartan in patients with type 2 diabetes and nephropathy.
A total of 1513 patients were enrolled in this randomized, double-blind study comparing losartan (50 to 100 mg once daily) with placebo, both taken in addition to conventional antihypertensive treatment (calcium-channel antagonists, diuretics, alpha-blockers, beta-blockers, and centrally acting agents), for a mean of 3.4 years. The primary outcome was the composite of a doubling of the base-line serum creatinine concentration, end-stage renal disease, or death. Secondary end points included a composite of morbidity and mortality from cardiovascular causes, proteinuria, and the rate of progression of renal disease.
A total of 327 patients in the losartan group reached the primary end point, as compared with 359 in the placebo group (risk reduction, 16 percent; P=0.02). Losartan reduced the incidence of a doubling of the serum creatinine concentration (risk reduction, 25 percent; P=0.006) and end-stage renal disease (risk reduction, 28 percent; P=0.002) but had no effect on the rate of death. The benefit exceeded that attributable to changes in blood pressure. The composite of morbidity and mortality from cardiovascular causes was similar in the two groups, although the rate of first hospitalization for heart failure was significantly lower with losartan (risk reduction, 32 percent; P=0.005). The level of proteinuria declined by 35 percent with losartan (P<0.001 for the comparison with placebo).
Losartan conferred significant renal benefits in patients with type 2 diabetes and nephropathy, and it was generally well tolerated.
糖尿病肾病是终末期肾病的主要病因。阻断肾素 - 血管紧张素系统可减缓1型糖尿病患者肾病的进展，但对于最常见的糖尿病类型2型糖尿病患者，尚无类似数据。我们评估了血管紧张素II受体拮抗剂氯沙坦在2型糖尿病肾病患者中的作用。
共有1513例患者参加了这项随机、双盲研究，将氯沙坦（每日一次，50至100毫克）与安慰剂进行比较，二者均在常规降压治疗（钙通道拮抗剂、利尿剂、α受体阻滞剂、β受体阻滞剂和中枢作用药物）基础上加用，平均治疗3.4年。主要结局是基线血清肌酐浓度翻倍、终末期肾病或死亡的复合结局。次要终点包括心血管病因导致的发病和死亡复合结局、蛋白尿以及肾病进展速率。
氯沙坦组共有327例患者达到主要终点，而安慰剂组为359例（风险降低16%；P = 0.02）。氯沙坦降低了血清肌酐浓度翻倍的发生率（风险降低25%；P = 0.006）和终末期肾病的发生率（风险降低28%；P = 0.002），但对死亡率无影响。其益处超过了血压变化所带来的益处。两组心血管病因导致的发病和死亡复合结局相似，尽管氯沙坦治疗时心力衰竭首次住院率显著降低（风险降低32%；P = 0.005）。氯沙坦治疗使蛋白尿水平下降了35%（与安慰剂比较，P < 0.001）。
氯沙坦对2型糖尿病肾病患者有显著的肾脏益处，且总体耐受性良好。
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