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Azilsartan/chlorthalidone Combination Therapy for Blood Pressure Control

Overview
Publisher Dove Medical Press
Date 2013 Jun 29
PMID 23807859
Citations 6
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Abstract

Background: Edarbyclor(®) is a combined angiotensin receptor blocker (ARB) and thiazide-like diuretic (azilsartan and chlorthalidone), and was approved on December 20, 2011 by the US Food and Drug Administration (FDA) for hypertension management.

Objective: To review the pharmacology, pharmacokinetics, efficacy, safety, tolerability, and role of azilsartan plus chlorthalidone for hypertension management.

Methods: Peer-reviewed clinical trials, review articles, and relevant treatment guidelines, were identified from the databases MEDLINE and Current Contents (both 1966 to February 15, 2013, inclusive) using search terms "azilsartan", "chlorthalidone", "pharmacology", "pharmacokinetics", "pharmacodynamics", "pharmacoeconomics", and "cost-effectiveness". The FDA website, as well as manufacturer prescribing information, was also reviewed to identify other relevant information.

Results: Azilsartan is a new ARB with high affinity for the angiotensin 1 receptor, approved by the FDA for hypertension management. Unlike other ARBs, azilsartan has no clinical data supporting improvement in cardiovascular outcomes, and is not approved for indications other than hypertension, which a select few other ARBs may be used for (eg, diabetic nephropathy and heart failure). Chlorthalidone is a longer acting thiazide-like diuretic that has been demonstrated to improve cardiovascular outcomes. Combination treatment with azilsartan/chlorthalidone is effective for reducing blood pressure. Compared to olmesartan/hydrochlorothiazide and azilsartan/hydrochlorothiazide combinations, azilsartan/chlorthalidone appears to be more efficacious for reducing blood pressure.

Conclusions: Azilsartan/chlorthalidone can be considered an antihypertensive therapy option in patients for whom combination therapy is required (blood pressure >20 mmHg systolic or >10 mmHg diastolic above goal). Cost to patients and insurance coverage will probably determine whether azilsartan/chlorthalidone will be the most appropriate combination therapy for an individual patient.

Citing Articles

Effects of Food Intake on the Pharmacokinetics of Azilsartan Medoxomil and Chlorthalidone Alone and in Fixed-Dose Combination in Healthy Adults.

Dudkowski C, Karim A, Munsaka M Clin Pharmacol Drug Dev. 2016; 5(5):393-8.

PMID: 27514506 PMC: 5069450. DOI: 10.1002/cpdd.249.


Evaluation of a Pharmacokinetic Interaction between Telmisartan and Chlorthalidone in Healthy Male Adult Subjects.

Seong S, Lim M, Lee J, Ohk B, Gwon M, Kim B Clin Drug Investig. 2016; 36(8):613-23.

PMID: 27206575 DOI: 10.1007/s40261-016-0406-y.


Diuretics in the treatment of hypertension.

Blowey D Pediatr Nephrol. 2016; 31(12):2223-2233.

PMID: 26983630 DOI: 10.1007/s00467-016-3334-4.


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

Handley A, Lloyd E, Roberts A, Barger B Clin Exp Hypertens. 2016; 38(2):180-8.

PMID: 26817604 PMC: 4819839. DOI: 10.3109/10641963.2015.1081213.


Safety, tolerability, and efficacy of azilsartan medoxomil with or without chlorthalidone during and after 8 months of treatment for hypertension.

Kipnes M, Handley A, Lloyd E, Barger B, Roberts A J Clin Hypertens (Greenwich). 2015; 17(3):183-92.

PMID: 25619410 PMC: 5024056. DOI: 10.1111/jch.12474.


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