Azisartan

O r i g i n a l

P a p e r

The Comparative Effects of Azilsartan Medoxomil and Olmesartan on Ambulatory and Clinic Blood Pressure
George L. Bakris, MD;1 Domenic Sica, MD;2 Michael Weber, MD;3William B. White, MD;4 Andrew Roberts, MS;5 Alfonso Perez, MD;5 Charlie Cao, PhD;5 Stuart Kupfer, MD5

The current study assesses the antihypertensive efficacy and safety of the investigationalangiotensin receptor blocker (ARB), azilsartan medoxomil (AZL-M), compared with placebo and the ARB olmesartan medoxomil (OLM-M). This randomized, double-blind, placebocontrolled, multicenter study assessedchange 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 systolicpressure !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 58Æ11 years, baseline mean24-hour SBP was 146 mm Hg. Dose-dependent
From the Hypertensive Diseases Unit, University of Chicago Pritzker School of Medicine, Chicago, IL;1 the Department of Medicine, Virginia CommonwealthUniversity, Richmond, VA;2 the SUNY Downstate, Department of Medicine, Brooklyn, NY;3 the Hypertension Center, University of Connecticut, Farmington, CT;4 and the Takeda Global Research and DevelopmentCenter, Inc., Deerfield, IL5 Address for correspondence: George Bakris, MD, Hypertensive Diseases Unit, University of Chicago Pritzker School of Medicine, 5841 South Maryland Avenue, MC 1027, Chicago, IL60637 E-mail: gbakris@gmail.com Manuscript received November 12, 2010; revised December 19, 2010; accepted December 21, 2010

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...