Effects of the angiotensin receptor blocker azilsartan medoxomil versus
olmesartan and valsartan on ambulatory and clinic blood pressure in patients with
stages 1 and 2 hypertension.
Author(s): White WB, Weber MA, Sica D, Bakris GL, Perez A, Cao C, Kupfer S.
Affiliation(s): Division of Hypertension and Clinical Pharmacology, Calhoun Cardiology Center,
University of Connecticut Health Center, 263 Farmington Ave, Farmington, CT
06030-3940, USA. wwhite@nso1.uchc.edu
Publication date & source: 2011, Hypertension. , 57(3):413-20
Azilsartan medoxomil is an angiotensin receptor blocker (ARB) being developed for
hypertension treatment. To compare this ARB with others in the class, we studied
the effects of 2 doses of azilsartan medoxomil, with valsartan 320 mg and
olmesartan medoxomil (olmesartan) 40 mg, in a randomized, double-blind,
placebo-controlled trial using ambulatory blood pressure (BP) monitoring and
clinic BP measurements. The primary efficacy end point was the change from
baseline in 24-hour mean systolic BP. Hierarchical analysis testing for
superiority over placebo was followed by noninferiority analysis and then
superiority testing of azilsartan medoxomil (80 mg and then 40 mg) versus the
comparator ARBs. For 1291 randomized patients, mean age was 56 years, 54% were
men, and baseline 24-hour mean systolic BP was 145 mm Hg. Azilsartan medoxomil at
80 mg had superior efficacy to both valsartan at 320 mg and olmesartan at 40 mg:
placebo-adjusted 24-hour systolic BP was lowered (-14.3 mm Hg) more than 320 mg
of valsartan (-10.0 mm Hg; P<0.001) and 40 mg of olmesartan (-11.7 mm Hg;
P=0.009). Azilsartan medoxomil at 40 mg was noninferior to 40 mg of olmesartan
(difference: -1.4 mm Hg [95% CI: -3.3 to 0.5]). For clinic systolic BP, both
doses of azilsartan medoxomil were superior to the comparator ARBs. Safety and
tolerability were similar among the placebo and 4 active treatments. These data
demonstrate that azilsartan medoxomil at its maximal dose has superior efficacy
to both olmesartan and valsartan at their maximal, approved doses without
increasing adverse events. Azilsartan medoxomil could provide higher rates of
hypertension control within the ARB class.
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