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Edarbyclor (azilsartan medoxomil and chlorthalidone) Head-to-Head Data Published in Hypertension
Date:6/19/2012

DEERFIELD, Ill., June 19, 2012 /PRNewswire/ -- Results of a 12-week, head-to-head, phase 3 study published online in the American Heart Association journal Hypertension found systolic blood pressure (SBP) reductions of a fixed-dose combination of azilsartan medoxomil and chlorthalidone 40/25 mg were statistically superior to those of the fixed-dose combination of olmesartan medoxomil-hydrochlorothiazide 40/25 mg. This fixed-dose combination (azilsartan medoxomil and chlorthalidone) is currently marketed as Edarbyclor in the United States. It is the first and only hypertension medication to combine an angiotensin II receptor blocker (ARB) with chlorthalidone, a diuretic, in a once-daily, single tablet.

"Hypertension and its impact on cardiovascular health have long been studied; the goal of this particular study was to determine whether a fixed-dose combination of a well-established yet underutilized diuretic paired with a new angiotensin II receptor blocker would provide an effective option to help control hypertension," said study co-author Michael Weber, M.D., professor of medicine, State University of New York, Downstate College of Medicine, Brooklyn, N.Y. "The data showed that Edarbyclor exhibited superior blood pressure reductions compared to a commonly used combination treatment."

Results after 12 weeks of treatment showed that the fixed-dose combination of azilsartan medoxomil and chlorthalidone 40/25 mg reduced clinic SBP by 42.5 mm Hg from baseline. The reductions were statistically significantly (P<0.001) greater than that of the fixed-dose combination of olmesartan medoxomil-hydrochlorothiazide 40/25 mg (37.1 mm Hg). Similar results were observed across patient subgroups, including age, gender or race. Edarbyclor was approved by the U.S. Food and Drug Administration in December 2011 for the treatment of hypertension to lower blood pressure in adults.

"Takeda has a long history in exploring new approaches for the manageme
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SOURCE Takeda Pharmaceuticals U.S.A., Inc.
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