Chan Juliana C N, Wat Nelson M S, So Wing-Yee, Lam Karen S L, Chua Chin-Teong, Wong Kok-Seng, Morad Zaki, Dickson Tania Z, Hille Darcy, Zhang Zhongxin, Cooper Mark E, Shahinfar Shahnaz, Brenner Barry M, Kurokawa Kiyoshi
Department of Medicine and Therapeutics, The Chinese University Hong Kong, The Prince of Wales Hospital, Hong Kong, Shatin, China.
Diabetes Care. 2004 Apr;27(4):874-9. doi: 10.2337/diacare.27.4.874.
Asia is predicted to have the largest population of patients with diabetes who are at high risk for renal disease. In the Reduction of Endpoints in NIDDM with the Angiotensin II Antagonist Losartan (RENAAL) study, approximately 17% of patients were Asians. In this subgroup analysis, we examined the characteristics, response, and adherence to treatment of the Asian population, as well as their baseline predictors of risk of renal end points.
A total of 252 Asian patients were enrolled in the RENAAL study, which compared losartan (50 mg titrated to 100 mg) to placebo in addition to conventional antihypertensive medications in type 2 diabetic patients with nephropathy. Mean follow-up was 3.2 years. The effect of losartan therapy on renal and cardiovascular outcomes was examined, and baseline predictors of risk were determined using a Cox proportional hazards model with prespecified baseline covariates.
Losartan reduced the risk of the primary composite end point composed of a doubling of serum creatinine, end-stage renal disease, or all-cause mortality in Asian patients by 35% (P = 0.02). No difference between losartan and placebo was observed for the cardiovascular composite outcomes. Losartan reduced the level of proteinuria by 47% (P < 0.001) and rate of decrease in renal function by 31% (0.0074). Discontinuations were lower in the losartan-treated patients. The strongest baseline predictors of risk of renal end points were proteinuria (hazard ratio 1.42, P < 0.0001) and low Hb (0.81, P < 0.0001).
In this subgroup analysis of the RENAAL study, losartan conferred significant renal benefits and was well tolerated in Asian patients with type 2 diabetes and clinical nephropathy. Baseline proteinuria and low Hb were strong predictors of risk of renal outcomes.
预计亚洲将拥有数量最多的糖尿病肾病高危患者。在使用血管紧张素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，约17%的患者为亚洲人。在这项亚组分析中，我们研究了亚洲人群的特征、对治疗的反应和依从性，以及他们发生肾脏终点事件风险的基线预测因素。
共有252名亚洲患者参与了RENAAL研究，该研究在2型糖尿病肾病患者中，除常规抗高血压药物外，将氯沙坦（50mg滴定至100mg）与安慰剂进行比较。平均随访时间为3.2年。研究了氯沙坦治疗对肾脏和心血管结局的影响，并使用包含预先指定基线协变量的Cox比例风险模型确定风险的基线预测因素。
氯沙坦使亚洲患者中由血清肌酐翻倍、终末期肾病或全因死亡率组成的主要复合终点事件风险降低了35%（P = 0.02）。在心血管复合结局方面，未观察到氯沙坦与安慰剂之间存在差异。氯沙坦使蛋白尿水平降低了47%（P < 0.001），肾功能下降率降低了31%（P = 0.0074）。氯沙坦治疗组的停药率较低。发生肾脏终点事件风险的最强基线预测因素是蛋白尿（风险比1.42，P < 0.0001）和低血红蛋白（0.81，P < 0.0001）。
在RENAAL研究的这项亚组分析中，氯沙坦对亚洲2型糖尿病合并临床肾病患者具有显著的肾脏益处，且耐受性良好。基线蛋白尿和低血红蛋白是肾脏结局风险的有力预测因素。
