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American Journal of Medicine Publishes Hypertension Study Comparing the Fixed-Dose Combination of Azilsartan Medoxomil and Chlorthalidone versus Azilsartan Medoxomil Co-administered with Hydrochlorothiazide
Date:9/5/2012

e -35.1 mm Hg. These data were statistically significantly (P<0.001) greater than those of azilsartan medoxomil and hydrochlorothiazide (-29.5 mm Hg) with a mean difference of -5.6 mm Hg. At the end of 10 weeks, greater clinic SBP reductions were maintained in patients taking the fixed-dose combination of azilsartan medoxomil and chlorthalidone (-37.8 mm Hg) versus those taking azilsartan medoxomil and hydrochlorothiazide (-32.8 mm Hg) with a mean difference of -5.0 mm Hg.

Additionally, secondary endpoint data showed that a greater proportion of patients taking the fixed-dose combination of azilsartan medoxomil and chlorthalidone achieved their target blood pressure versus those taking azilsartan medoxomil and hydrochlorothiazide at the end of both six weeks (64.1 percent vs. 45.9 percent) and 10 weeks (71.5 percent vs. 62.3 percent).

Adverse events leading to permanent drug discontinuation occurred in 9.3 percent of patients taking the fixed-dose combination of azilsartan medoxomil and chlorthalidone and 7.3 percent of patients taking azilsartan medoxomil co-administered with hydrochlorothiazide. The most common adverse events accounting for study drug discontinuation were dizziness (1.0 percent versus 1.7 percent) and increased serum creatinine (4.0 percent versus 2.0 percent) in the fixed-dose combination of azilsartan medoxomil and chlorthalidone and azilsartan medoxomil and hydrochlorothiazide groups, respectively. The most common adverse events (greater or equal to five percent in either group) were increased blood creatinine, dizziness and headache. Serum potassium levels below 3.4 mmol/L were observed in 1.7 percent and 0.3 percent of patients in the fixed-dose combination of azilsartan medoxomil and chlorthalidone and azilsartan medoxomil and hydrochlorothiazide groups, respectively.

Edarbyclor (azilsartan medoxomil and chlorthalidone) was approved by the U.S. Food and Drug Administration in December 2011 for the treatment of hypert
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SOURCE Takeda Pharmaceuticals U.S.A., Inc.
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