N. Muirhead et al., The effects of valsartan and captopril on reducing microalbuminuria in patients with type 2 diabetes mellitus: A placebo-controlled trial, CURR THER R, 60(12), 1999, pp. 650-660
Citations number
18
Categorie Soggetti
Pharmacology,"Pharmacology & Toxicology
Journal title
CURRENT THERAPEUTIC RESEARCH-CLINICAL AND EXPERIMENTAL
This multicenter, randomized, double-blind, placebo- and captopril-controll
ed, parallel-group trial evaluated the efficacy and safety of valsartan 80
and 160 mg in patients with incipient diabetic nephropathy, Patients were r
andomized 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 microalbumi
nuria (mean age, 56 years; 90% white). Treatment lasted 52 weeks. Efficacy
variables included albumin excretion rate (AER), progression to clinical pr
oteinuria, 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 decr
ease in AER from baseline was observed at end point, compared with an incre
ase in the placebo group (n = 31). The positive effect of valsartan 80 mg v
ersus placebo on AER was statistically significant (95% confidence interval
[CI] for end point/ baseline ratio: 0.365 to 0.966); the 95% CI for valsar
tan 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 ve
rsus captopril. The percentage of patients with trial drug-related adverse
experiences was highest in the captopril group (34.5%), The corresponding v
alues for the groups receiving valsartan 80 mg, valsartan 160 mg, and place
bo 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 normote
nsive and treated hypertensive patients with type 2 diabetes mellitus with
comparable efficacy and superior tolerability to captopril.