Safety and tolerability of azilsartan medoxomil in subjects with essential hypertension: a one-year, phase 3, open-label study

Autor:	Bruce Barger, Eric E. Lloyd, Andrew V. Roberts, Alison Handley
Jazyk:	angličtina
Rok vydání:	2016
Předmět:	Adult Male medicine.medical_specialty Physiology Sodium Chloride Symporter Inhibitors diuretic 030204 cardiovascular system & hematology Pharmacology Essential hypertension Dizziness Article azilsartan Cohort Studies 03 medical and health sciences 0302 clinical medicine Hydrochlorothiazide Internal medicine Azilsartan Internal Medicine Medicine Humans 030212 general & internal medicine Azilsartan Medoxomil angiotensin receptor blocker Fatigue Aged Oxadiazoles business.industry Headache Chlorthalidone General Medicine Original Articles Middle Aged medicine.disease hydrochlorothiazide Blood pressure Treatment Outcome Tolerability Cohort Hypertension Benzimidazoles Drug Therapy Combination Female Essential Hypertension business medicine.drug
Zdroj:	Clinical and Experimental Hypertension
ISSN:	1525-6006 1064-1963
Popis:	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.
Databáze:	OpenAIRE
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