Key result
The combination of valsartan and lisinopril significantly reduced the urine albumin creatinine ratio compared with lisinopril alone (adjusted ratio 60%; 95% CI 38-94%; P=0.029).
Why the study?
Does the combination of valsartan and lisinopril reduce urine albumin creatinine ratio in hypertensive patients with microalbuminuria compared to high-dose monotherapies?
RCT (n=133)
Double-blind
1:1:1
Does the combination of valsartan and lisinopril reduce urine albumin creatinine ratio in hypertensive patients with microalbuminuria compared to high-dose monotherapies?
The combination of valsartan and lisinopril provided a significantly better reduction of urine albumin creatinine ratio compared with lisinopril alone in hypertensive patients with microalbuminuria.
Answers are grounded in this paper and cite their sources.
Supports dual RAS blockade over ACEI monotherapy for albuminuria reduction; extends monotherapy evidence in hypertensive microalbuminuria.
OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.
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Menne et al. (2008) conducted an RCT in Hypertension and microalbuminuria (n=133). Valsartan and lisinopril combination vs. Lisinopril 40 mg or valsartan 320 mg was evaluated on Urine albumin creatinine ratio (adjusted ratio 60%, 95% CI 38-94, p=0.029). The combination of valsartan and lisinopril significantly reduced the urine albumin creatinine ratio compared with lisinopril alone (adjusted ratio 60%; 95% CI 38-94%; P=0.029).
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