Menne Jan, Farsang Csaba, Deák László, Klebs Sven, Meier Matthias, Handrock Renate, Sieder Christian, Haller Hermann
Department of Nephrology, Medical School Hannover, Hannover, Germany.
J Hypertens. 2008 Sep;26(9):1860-7. doi: 10.1097/HJH.0b013e32830508aa.
Microalbuminuria is known as an independent predictor for stroke, myocardial infarction, and death. The purpose of the VALERIA trial was a comparison of the efficacy and safety of combination therapy of valsartan and lisinopril with valsartan and lisinopril high-dose monotherapy in patients with hypertension and microalbuminuria.
This was a randomized, double-blind, interventional, parallel-group study. After a washout/placebo-run-in phase of 3 weeks, 133 patients were randomized to treatment (1: 1:1) with either lisinopril 40 mg, valsartan 320 mg, or a combination of valsartan/lisinopril 320/20 mg for 30 weeks.
At baseline, the urine albumin creatinine ratio was similar for the three treatment groups (geometric means, lisinopril 9.6 mg/mmol, valsartan 9.1 mg/mmol, and valsartan/lisinopril 9.5 mg/mmol). After 30 weeks of treatment, the geometric mean urine albumin creatinine ratio had decreased in all three groups by 41, 51, and 62% to 5.7 mg/mmol (lisinopril), 4.5 mg/mmol (valsartan), and 3.6 mg/mmol (valsartan/lisinopril). The decrease for valsartan/lisinopril was statistically significantly greater compared with lisinopril [adjusted ratio 60%, confidence interval (38-94%), P = 0.029]. Normalization of microalbuminuria was greatest with valsartan and valsartan/lisinopril (lisinopril 17%, valsartan 31%, and valsartan/lisinopril 38% of patients) and was statistically significant for lisinopril in contrast with valsartan/lisinopril (P = 0.034). Differences in blood pressure reduction between the groups were not statistically significant. All treatments were safe and well tolerated.
The combination of valsartan and lisinopril provided a significantly better reduction of urine albumin creatinine ratio and more than doubled the rate of patients with normalized urine albumin creatinine ratio compared with lisinopril alone. All treatments were safe and well tolerated.
微量白蛋白尿是中风、心肌梗死和死亡的独立预测指标。VALERIA试验的目的是比较缬沙坦与赖诺普利联合治疗和缬沙坦与赖诺普利高剂量单药治疗在高血压合并微量白蛋白尿患者中的疗效和安全性。
这是一项随机、双盲、干预性平行组研究。在为期3周的洗脱/安慰剂导入期后，133例患者被随机分配接受治疗（1:1:1），分别使用赖诺普利40mg、缬沙坦320mg或缬沙坦/赖诺普利320/20mg，治疗30周。
基线时，三个治疗组的尿白蛋白肌酐比值相似（几何均值，赖诺普利组为9.6mg/mmol，缬沙坦组为9.1mg/mmol，缬沙坦/赖诺普利组为9.5mg/mmol）。治疗30周后，所有三组的尿白蛋白肌酐比值几何均值均下降，分别下降了41%、51%和62%，降至5.7mg/mmol（赖诺普利组）、4.5mg/mmol（缬沙坦组）和3.6mg/mmol（缬沙坦/赖诺普利组）。与赖诺普利相比，缬沙坦/赖诺普利组的下降幅度在统计学上显著更大[校正比值60%，置信区间（38 - 94%），P = 0.029]。微量白蛋白尿正常化比例在缬沙坦组和缬沙坦/赖诺普利组最高（赖诺普利组为17%，缬沙坦组为31%，缬沙坦/赖诺普利组为38%的患者），与缬沙坦/赖诺普利组相比，赖诺普利组差异有统计学意义（P = 0.034）。各组间血压降低差异无统计学意义。所有治疗均安全且耐受性良好。
与单独使用赖诺普利相比，缬沙坦与赖诺普利联合使用能显著更好地降低尿白蛋白肌酐比值，使尿白蛋白肌酐比值正常化的患者比例增加了一倍多。所有治疗均安全且耐受性良好。
