Department of Medicine, Division of Nephrology and Hypertension, St Marianna University School of Medicine, Kawasaki, Japan.
Hypertens Res. 2013 Mar;36(3):240-6. doi: 10.1038/hr.2012.183. Epub 2012 Nov 15.
Suppression of the renin-angiotensin system is known to slow progression of chronic kidney disease (CKD). However, few trials have been performed with Japanese patients. This study investigated whether the angiotensin receptor blocker (ARB) valsartan would delay the progression of kidney disease more effectively than conventional treatment in Japanese hypertensive patients with advanced, predialysis CKD. In a multicenter, randomized, open-label trial, 303 patients with hypertension and CKD with serum creatinine levels 2.0 mg dl(-1) were assigned to receive either conventional therapy plus valsartan (valsartan add-on group) or conventional therapy without ARB (control group). The primary outcome was a change in serum creatinine levels. Changes in urinary protein levels and time to onset of renal events were analyzed as secondary end points. There were no between-group differences in blood pressure during the study. Changes in serum creatinine and urinary protein levels did not differ between the groups. However, the rate of renal events, including doubling of serum creatinine levels or end-stage renal disease, was significantly lower in the valsartan add-on group than in the control group. The addition of valsartan decreased the risk by 42.6% after adjustment for baseline variables. The addition of valsartan to conventional therapy significantly slowed the rate of renal function decline and delayed the need for renal replacement therapy in Japanese hypertensive patients with advanced CKD.
抑制肾素-血管紧张素系统已知可减缓慢性肾脏病(CKD)的进展。然而,很少有针对日本患者的试验。本研究旨在探讨血管紧张素受体阻滞剂(ARB)缬沙坦是否比常规治疗更能有效延缓日本高血压合并晚期、未透析 CKD 患者的肾脏疾病进展。在一项多中心、随机、开放标签试验中,303 名血清肌酐水平为 2.0mg/dl(1)的高血压和 CKD 患者被随机分为常规治疗加缬沙坦(缬沙坦加用组)或不使用 ARB 的常规治疗(对照组)。主要终点是血清肌酐水平的变化。尿蛋白水平的变化和肾脏事件的发生时间被分析为次要终点。在研究期间,两组之间的血压没有差异。两组之间血清肌酐和尿蛋白水平的变化没有差异。然而,缬沙坦加用组的肾脏事件发生率,包括血清肌酐水平翻倍或终末期肾病,明显低于对照组。调整基线变量后,缬沙坦的添加使风险降低了 42.6%。在日本高血压合并晚期 CKD 患者中,常规治疗加用缬沙坦可显著减缓肾功能下降速度,并延迟肾脏替代治疗的需要。