title: Safety and tolerability of azilsartan medoxomil in subjects with essential hypertension: a one-year, phase 3, open-label study.
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.
authors.affiliation: a Takeda Pharmaceuticals International, Inc. , Deerfield , IL , USA and.
authors.forename: Alison
authors.initials: A
authors.lastname: Handley
authors.affiliation: b Takeda Development Center Americas, Inc. , Deerfield , IL , USA .
authors.forename: Eric
authors.initials: E
authors.lastname: Lloyd
authors.affiliation: b Takeda Development Center Americas, Inc. , Deerfield , IL , USA .
authors.forename: Andrew
authors.initials: A
authors.lastname: Roberts
authors.affiliation: b Takeda Development Center Americas, Inc. , Deerfield , IL , USA .
authors.forename: Bruce
authors.initials: B
authors.lastname: Barger
mesh_terms: D000328:Adult; D000368:Aged; D001562:Benzimidazoles / Q000627:therapeutic use*; D002752:Chlorthalidone / Q000627:therapeutic use; D015331:Cohort Studies; D004244:Dizziness / Q000139:chemically induced*; D004359:Drug Therapy, Combination; D000075222:Essential Hypertension; D005221:Fatigue / Q000139:chemically induced*; D005260:Female; D006261:Headache / Q000139:chemically induced*; D006801:Humans; D006852:Hydrochlorothiazide / Q000627:therapeutic use; D006973:Hypertension / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010069:Oxadiazoles / Q000627:therapeutic use*; D049993:Sodium Chloride Symporter Inhibitors / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D001562:Benzimidazoles; D010069:Oxadiazoles; D049993:Sodium Chloride Symporter Inhibitors; D006852:Hydrochlorothiazide; C557413:azilsartan medoxomil; D002752:Chlorthalidone
keywords: Hypertension; angiotensin receptor blocker; azilsartan; chlorthalidone; diuretic; hydrochlorothiazide
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