Fixed-dose ARB combo superior treatment for hypertension

July 13, 2012

A fixed-dose combination of azilsartan medoxomil and chlorthalidone 40/25 mg (Edarbyclor, Takeda Pharmaceuticals) was statistically superior to a fixed-dose combination of olmesartan medoxomil-hydrochlorothiazide 40/25 mg for the treatment of stage 2 systolic hypertension, according to a study published online in the American Heart Association journal Hypertension.

A fixed-dose combination of azilsartan medoxomil and chlorthalidone 40/25 mg (Edarbyclor, Takeda Pharmaceuticals) was statistically superior to a fixed-dose combination of olmesartan medoxomil-hydrochlorothiazide 40/25 mg for the treatment of stage 2 systolic hypertension, according to a study published online in the American Heart Association journal Hypertension.

Azilsartan medoxomil is a newly approved, long-acting angiotensin II receptor blocker (ARB), and Edarbyclor is the first and only hypertension medication to combine an ARB with chlorthalidone, a diuretic, in a once-daily, single tablet, according to the study and a statement from Takeda Pharmaceuticals.

The multicenter study, lead by William C. Cushman, MD, of the University of Tennessee College of Medicine in Memphis, Tenn., was a large, forced-titration, active-comparator study of the ARB-chlorthalidone combination. Dr Cushman and colleagues compared the antihypertensive efficacy, safety, and tolerability of 2 fixed-dose combinations of azilsartan medoxomil plus chlorthalidone, force titrated from 20/12.5 mg and 40/12.5 mg to 40/25 mg and 80/25 mg, with the ARB fixed-dose combination of olmesartan medoxomil plus hydrochlorothiazide, force titrated from 20/12.5 mg to 40/25 mg, in 1,071 patients with stage 2 systolic hypertension. They used measurements of both clinic and ambulatory blood pressures (BPs) to assess antihypertensive efficacy.

After 12 weeks of treatment, both fixed-dose combinations of azilsartan medoxomil and chlorthalidone had more effectively reduced clinic systolic BP (P<.001) compared with the fixed-dose combination of olmesartan medoxomil-hydrochlorothiazide.

Adverse events that lead to study discontinuation occurred in 7.9% of patients taking azilsartan medoxomil and chlorthalidone 40/25 mg and 7.1% of patients taking olmesartan medoxomil-hydrochlorothiazide 40/25 mg, the most common being increases in serum creatinine and dizziness, which occurred more frequently and in a dose-dependent manner with azilsartan medoxomil/chlorthalidone.

“The implication of these results is that this single-pill combination of 2 antihypertensive drugs may provide BP control to recommended target BP levels for a higher proportion of hypertensive patients than other 2-drug [fixed-dose combinations],” the authors concluded. “Although some hypertensive patients will require more medications to achieve their BP goal, the subsequent regimen will likely require fewer additional drugs.”