RESULTS OF A NOVEL ANGIOTENSIN RECEPTOR BLOCKER, AZILSARTAN MEDOXOMIL, IN PATIENTS WITH PRIMARY HYPERTENSION: 9A.01

Abstract

Objective: We compared blood pressure (BP) lowering of a novel angiotensin II receptor blocker (ARB), azilsartan medoxomil (AZL-M), with placebo and another ARB, olmesartan medoxomil (OLM-M), in patients with primary hypertension using ambulatory BP monitoring (ABPM) and clinic measurement. Design and Method: In this 6-week, multicenter, double-blind, randomized controlled study, the primary endpoint was change in 24-hour mean systolic BP (SBP) by ABPM. Other outcomes were clinic BP, trough SBP at 22–24 hours by ABPM, and safety. We treated 1272 patients. Sample size was calculated for 90% power to detect a 5.5-mm Hg difference from placebo and 4 mm Hg between treatments. Results: Final ABPM data were available for 86% of patients (age 58 ± 11 yrs [mean ± SD]; 73% Caucasian, 11% African-American, 12% Hispanic; body mass index 30.2 ± 6 kg/m2). AZL-M 80 mg reduced 24-hour mean SBP most, followed by AZL-M 40 mg and OLM-M 40 mg (Table). AZL-M 80 mg lowered clinic BP more than OLM-M 40 mg (placebo-corrected difference -15.5/-8.6 vs -12.8/-7.1 mm Hg); treatment differences were -2.7 mm Hg SBP (95% CI -5.34, -0.09; P = 0.043) and -1.5 mm Hg DBP (95% CI -2.98, -0.04; P = 0.044). AZL-M tended to reduce 22- to 24-hour SBP by ABPM more than OLM-M (treatment difference -2.3 mm Hg; 95% CI -4.70, 0.04; P = 0.054). Adverse effects were similar. Headache was most common with placebo. Conclusions: AZL-M lowered 24-hour mean SBP in a dose-related fashion, and AZL-M at its maximum 80-mg dose was more efficacious than OLM-M 40 mg. Similar results for AZL-M were observed for clinic BP measurements.