Safety and Tolerability of Azilsartan Medoxomil in Subjects with Essential Hypertension: a One-year, Phase 3, Open-label Study

Overview

Journal Clin Exp Hypertens

Publisher Informa Healthcare

Specialty Cardiology & Vascular Diseases

Date 2016 Jan 29

PMID 26817604

Citations 7

Authors

Alison Handley

Eric Lloyd

Andrew Roberts

Bruce Barger

Affiliations

Soon will be listed here.

Abstract

This 56-week phase 3, open-label, treat-to-target study, involving 2 consecutive, non-randomized cohorts, evaluated the safety and tolerability of azilsartan medoxomil (AZL-M) in essential hypertension (mean baseline blood pressure [BP] 152/100 mmHg). All subjects (n = 669) initiated AZL-M 40 mg QD, force-titrated to 80 mg QD at week 4, if tolerated. From week 8, subjects could receive additional medications, starting with chlorthalidone (CLD) 25 mg QD (Cohort 1) or hydrochlorothiazide (HCTZ) 12.5-25 mg QD (Cohort 2), if required, to reach BP targets. Adverse events (AEs) were reported in 75.9% of subjects overall in the two cohorts (73.8% Cohort 1, 78.5% Cohort 2). The most common AEs were dizziness (14.3%), headache (9.9%) and fatigue (7.2%). Transient serum creatinine elevations were more frequent with add-on CLD. Clinic systolic/diastolic BP (observed cases at week 56) decreased by 25.2/18.4 mmHg (Cohort 1) and 24.2/17.9 mmHg (Cohort 2). These results demonstrate that AZL-M is well tolerated over the long term and provides stable BP improvements when used in a treat-to-target BP approach with thiazide-type diuretics.

Citing Articles

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Chiropractic care for hypertension: Review of the literature and study of biological and genetic bases.

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A phase 3 double-blind randomized (CONSORT-compliant) study of azilsartan medoxomil compared to valsartan in Chinese patients with essential hypertension.

Wu J, Du X, Lv Q, Li Z, Zheng Z, Xia Y Medicine (Baltimore). 2020; 99(32):e21465.

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