• Andrew Lewin, Henry Punzi, Xiaohui Luo, and Manfred Stapff.
• National Research Institute, Los Angeles, CA 90057, USA. docl@clinical-studies.com
• Clin Ther. 2013 Feb 1; 35 (2): 142-52.

BackgroundElevated systolic blood pressure (SBP) is an independent risk factor for cardiovascular events and mortality.ObjectiveThe goal of this study was to assess whether nebivolol (NEB), a vasodilatory β(1)-selective blocker, is a safe and efficacious monotherapy for individuals with systolic stage II hypertension.MethodsIn this multicenter trial, 18- to 64-year-olds who had not used antihypertensive treatment for at least 4 weeks and had SBP/diastolic blood pressure (DBP) of 160 to 180/90 to 110 mm Hg were randomized to receive double-blind medication for 6 weeks (NEB, n = 290; placebo [PBO], n = 142). Depending on response, the starting dose (5 mg/d) could be increased directly to 20 mg/d. Primary parameters were baseline-end point changes in trough seated SBP and DBP (intent-to-treat [ITT] population); the Hochberg method was used to control the type I error (α = 0.05). Responder analysis was also performed. Safety and tolerability assessment included monitoring of adverse events (AEs).ResultsMean age at baseline (ITT) was 50.7 years, and the mean SBP/DBP values were 167/101 mm Hg; 202 (47.3%) participants were women, 276 (63.9%) had body mass index ≥30 kg/m(2), 152 (35.2%) were black, and 161 (37.3%) were Hispanic. Completion rates were 79.7% (PBO) and 90.3% (NEB). After 2 weeks of treatment, 92% and 95% participants in the NEB and PBO groups, respectively, had SBP in the range of 130 to 180 mm Hg and were titrated to the 20-mg/d NEB dose or its matching PBO tablet. After 6 weeks of treatment, the NEB group experienced significant mean reductions compared with the PBO group for both SBP (-18.2 vs -12.3 mm Hg; P < 0.001) and DBP (-12.3 vs -5.7 mm Hg; P < 0.001), down to mean SBP/DBP values of 149/89 mm Hg and 155/95 mm Hg, respectively, and had a significantly higher percentage of individuals who achieved BP control (SBP/DBP <140/90 mm Hg, 30.6% vs 17.3%; P = 0.004). Post hoc analyses suggest that NEB was not efficacious in reducing SBP in black participants. Mean changes in pulse rate were -12.8 beats/min for the NEB group and -1.6 beats/min for the PBO group (P < 0.001). Rates of discontinuations due to an AE (NEB vs PBO) were 1.4% in both groups, rates of any treatment-emergent AEs were 19.7% versus 19.0%, and rates of serious AEs were 0.3% versus 2.1%. The most common AEs (NEB vs PBO) were headache (2.1% vs 2.8%) and hypertension (0.7% vs 2.1%).ConclusionsNEB monotherapy was an efficacious and well-tolerated treatment option for these study individuals with systolic stage II hypertension, but most of them would need combination therapy to achieve BP control.Copyright © 2013 Elsevier HS Journals, Inc. All rights reserved.

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