Home » Drug Information » FDA Approved Drugs » 2011
Medical Areas: Cardiology/Vascular Diseases | Family Medicine
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Edarbyclor (azilsartan medoxomil and chlorthalidone)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved December of 2011
Treatment Area: hypertension
Edarbyclor is a fixed dose combination of azilsartan medoxomil, an angiotensin II receptor blocker, and the diuretic chlorthalidone. The sodium and water depletion
action of chlorthalidone appear to provide a basis for its antihypertensive effect.
Edarbyclor is specifically indicated for the treatment of hypertension, to lower blood pressure in the following populations: those not adequately controlled with monotherapy and as initial therapy in patients likely to need multiple drugs to help
achieve blood pressure goals.
Edarbyclor is supplied as a tablet for oral administration. The recommended starting dose of Edarbyclor is 40/12.5 mg taken orally once daily. The dosage may be increased to 40/25 mg after 2 to 4 weeks as needed to achieve blood pressure goals.
The FDA approval of Edarbyclor was based on five randomized controlled studies, which included four double-blind, active-controlled studies and 1 open-label, long-term active-controlled study. The studies ranged from 8 weeks to 12 months in duration, at doses ranging from 20/12.5 mg to 80/25 mg once daily. A total of 5,310 subjects with moderate or severe hypertension were enrolled.
An 8-week, multicenter, randomized, double-blind, active-controlled, parallel group factorial trial enrolled 1,714 subjects with baseline systolic blood pressure between 160 and 190 mm Hg (mean 165 mm Hg) and a baseline diastolic blood pressure <119 mm Hg (mean 95 mm Hg) to one of the 11 active treatment arms. The trial compared the effect on blood pressure of Edarbyclor with the respective monotherapies. The six treatment combinations of azilsartan medoxomil 20, 40, or 80 mg and chlorthalidone 12.5 or 25 mg resulted in statistically significant reduction in systolic and diastolic blood pressure as determined by ambulatory blood pressure monitoring (ABPM) and clinic measurement at trough compared with the respective individual monotherapies. The blood pressure lowering effect was maintained throughout the 24-hour period.
In a 12-week, double-blind forced-titration trial, Edarbyclor 40/25 mg was statistically superior (P<0.001) to olmesartan medoxomil/hydrochlorothiazide (OLM/HCTZ) 40/25 mg in reducing systolic blood pressure in subjects with moderate to severe hypertension. Similar results were observed in all subgroups, including age, gender, or race. Edarbyclor lowered blood pressure more effectively than OLM/HCTZ at each hour of the 24-hour interdosing period as measured by ABPM.
Adverse events associated with the use of Edarbyclor may include, but are not limited to, the following:
Mechanism of Action
Edarbyclor target two separate mechanisms involved in blood pressure
regulation. Azilsartan blocks the vasoconstriction and sodium retaining effects of angiotensin II on cardiac, vascular smooth muscle, adrenal and renal cells. Chlorthalidone produces diuresis with increased excretion of sodium and chloride at the cortical diluting segment of the ascending limb of Henle’s loop of the nephron.
For additional information regarding Edarbyclor or hypertension, please visit the Takeda web page.