Amlodipine/valsartan fixed-dose combination treatment in the management of hypertension: A double-blind, randomized trial.

ABSTRACT:

Background

To compare the fixed-dose combination (FDC) of amlodipine/valsartan 5/80 mg with valsartan 160 mg monotherapy for efficacy and safety in hypertensive patients.

Methods

We designed this double-blind, randomized, and noninferiority trial in which patients with elevated systolic blood pressure (SBP) and/or diastolic blood pressure (DBP) were randomly assigned to receive amlodipine/valsartan 5/80 mg FDC or valsartan 160 mg monotherapy for 8 weeks. The primary endpoint was changes in office SBP and DBP from baseline to 8 weeks. Twenty-four-hour blood pressure (BP) and the incidence of adverse events were recorded.

Results

A total of 42 patients underwent randomization. At 8 weeks, office SBP changes were -16.5 ± 15.5 mmHg (p < 0.001) with amlodipine/valsartan 5/

SUBMITTER: Wang KL 

PROVIDER: S-EPMC7526577 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature