Comparison of the novel angiotensin ii receptor blocker azilsartan medoxomil vs valsartan by ambulatory blood pressure monitoring

Abstract

Azilsartan medoxomil (AZL-M) is a unique angiotensin II receptor blocker (ARB) under development for the treatment of hypertension. To compare this ARB with another in the class, the authors studied the effects of AZL-M and valsartan (VAL) in 984 patients with primary hypertension in a randomized, double-blind, multicenter study using ambulatory and clinic blood pressure (BP) measurements. The primary end point was change from baseline in 24-hour mean ambulatory systolic BP following 24weeks of treatment. Hierarchical analysis testing for noninferiority was followed by superiority testing of AZL-M (80 mg then 40mg) vs VAL. The mean age of participants was 58 years, 52% were men, and 15% were black. Baseline 24-hour mean systolic BP was similar (approximately 145.6mmHg) in each group. AZL-M 40 mg and 80mg lowered 24-hour mean systolic BP (-14.9 mm Hg and -15.3mmHg, respectively) more than VAL 320mg (-11.3mmHg; P