New combination therapy offers promising approach for hypertension management

(CardiologyToday.com) — Among patients with stage II systolic hypertension, azilsartan medoxomil, a newly approved angiotensin II receptor blocker, plus chlorthalidone led to greater reductions in systolic BP compared with olmesartan plus hydrochlorothiazide, according to findings presented here at the American Society of Hypertension 2011 Annual Scientific Meeting and Exposition.

According to study investigator William C. Cushman, MD, of the University of Tennessee College of Medicine in Memphis, this was the first large, forced titration study of an angiotensin II receptor blocker fixed-dose combination.

“This [study] gives the maximum comparison in terms of the effectiveness of these products … and demonstrates superior efficacy of the [azilsartan medoxomil-chlorthalidone] fixed-dose combinations compared with [olmesartan-hydrochlorothiazide],” Cushman said in a press conference.

In the phase 3, multicenter, double blind, randomized study, the effects of two doses of azilsartan medoxomil (AZL-M; Edarbi, Takeda Pharmaceuticals) plus chlorthalidone (CLD) were compared with olmesartan (OLM) plus hydrochlorothiazide (HCTZ). The study design called for force titrating to maximum doses for all three arms during a 12-week interval: 20 mg AZL-M/12.5 mg CLD to 40 mg AZL-M/25 mg CLD (n=355); 40 mg AZL-M/12.5 mg CLD to 80 mg AZL-M/25 mg (n=352); and 20 mg OLM/12.5 mg HCTZ to 40 mg OLM/25 mg HCTZ (n=364). Only patients aged at least 18 years and with post-washout clinic systolic BP of between 160 mm Hg and 190 mm Hg were included.

At 12 weeks, the study’s primary endpoint of change in clinic systolic BP favored both the 40/25-mg (–42.5 mm Hg) and 80/25-mg AZL-M arms (–44 mm Hg) vs. the OLM arm (–37.1 mm Hg; P<.001 for both comparisons). Similarly, change in 24-hour mean systolic BP also favored the 40/25-mg (–33.9 mm Hg) and 80/25-mg AZL-M arms (–36.3 mm Hg) compared with the OLM arm (–27.5 mm Hg; P<.001 for both).

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