The comparative effects of azilsartan medoxomil and olmesartan on ambulatory and clinic blood pressure

Abstract

The current study assesses the antihypertensive efficacy and safety of the investigational angiotensin receptor blocker (ARB), azilsartan medoxomil (AZL-M), compared with placebo and the ARB olmesartan medoxomil (OLM-M). This randomized, double-blind, placebo-controlled, multicenter study assessed change from baseline in mean 24-hour ambulatory systolic blood pressure (SBP) following 6 weeks of treatment. Patients with primary hypertension (n=1275) and baseline 24-hour mean ambulatory systolic pressure ≥ 130 mm Hg and ≤ 170 mm Hg were studied; 142 received placebo and the remainder received 20 mg, 40 mg, or 80 mg AZL-M or 40 mg OLM-M. Mean age of participants was 58 ± 11 years, baseline mean 24-hour SBP was 146 mm Hg. Dose-dependent reductions in 24-hour mean SBP at study end occurred in all AZL-M groups. Reduction in 24-hour mean SBP was greater with AZL-M 80 mg than OLM-M 40 mg by 2.1 mm Hg (95% confidence interval, -4.0 to -0.1; P=.038), while AZL-M 40 mg was noninferior to OLM-M 40 mg. The side effect profiles of both ARBs were similar to placebo. AZL-M is well tolerated and more efficacious at its maximal dose than the highest dose of OLM-M.

© 2011 Wiley Periodicals, Inc.

Figures

Figure 1

Patient disposition. Data are number (percentage). AZL‐M indicates azilsartan medoxomil; OLM‐M, olmesartan medoxomil; DC, discontinuation; WD, withdrawal. The 3 most common reasons for discontinuation are listed.

Figure 2

Change from baseline in 24‐hour mean systolic blood pressure (SBP) and clinic SBP at study end. Superiority of azilsartan medoxomil (AZL‐M) 80 mg vs olmesartan medoxomil (OLM‐M) 40 mg was not examined for clinic SBP because the stepwise analysis was terminated at the comparison of AZL‐M 40 mg vs OLM‐M for noninferiority. LS indicates least‐squares; SE, standard error of the mean.

Figure 3

Change from baseline in ambulatory systolic blood pressure by hour at study end. AZL‐M indicates azilsartan medoxomil; OLM‐M, olmesartan medoxomil.

Figure 4

Change from baseline in clinic systolic blood pressure by study visit. Includes all patients with baseline and post‐baseline values with the last observation carried forward. AZL‐M indicates azilsartan medoxomil; OLM‐M, olmesartan medoxomil.