The effects of valsartan and captopril on reducing microalbuminuria in patients with type 2 diabetes mellitus: A placebo-controlled trial

This multicenter, randomized, double-blind, placebo- and captopril-controlled, parallel-group trial evaluated the efficacy and safety of valsartan 80 and 160 mg in patients with incipient diabetic nephropathy, Patients were randomized to receive either valsartan 80 mg or 160 mg once daily, captopril 25 mg 3 times daily, or placebo. The study comprised 122 normotensive and treated hypertensive patients with type 2 diabetes mellitus and microalbuminuria (mean age, 56 years; 90% white). Treatment lasted 52 weeks. Efficacy variables included albumin excretion rate (AER), progression to clinical proteinuria, and glomerular filtration rate. In both the valsartan 80-mg (n = 31) and 160-mg (n = 31) groups and in the captopril group (n = 29), a decrease in AER from baseline was observed at end point, compared with an increase in the placebo group (n = 31). The positive effect of valsartan 80 mg versus placebo on AER was statistically significant (95% confidence interval [CI] for end point/ baseline ratio: 0.365 to 0.966); the 95% CI for valsartan 160 mg versus placebo was 0.407 to 1.043, No significant differences in AER occurred in the comparisons of valsartan 80 mg and valsartan 160 mg versus captopril. The percentage of patients with trial drug-related adverse experiences was highest in the captopril group (34.5%), The corresponding values for the groups receiving valsartan 80 mg, valsartan 160 mg, and placebo were 9.7%, 22.6%, and 13.8%, respectively. Results of this study suggest that treatment with valsartan slows the progressive rise of AER in normotensive and treated hypertensive patients with type 2 diabetes mellitus with comparable efficacy and superior tolerability to captopril.