PMID- 23332366
OWN - NLM
STAT- MEDLINE
DCOM- 20130813
LR  - 20211203
IS  - 1879-114X (Electronic)
IS  - 0149-2918 (Linking)
VI  - 35
IP  - 2
DP  - 2013 Feb
TI  - Nebivolol monotherapy for patients with systolic stage II hypertension: results 
      of a randomized, placebo-controlled trial.
PG  - 142-52
LID - S0149-2918(12)00730-8 [pii]
LID - 10.1016/j.clinthera.2012.12.015 [doi]
AB  - BACKGROUND: Elevated systolic blood pressure (SBP) is an independent risk factor 
      for cardiovascular events and mortality. OBJECTIVE: The goal of this study was to 
      assess whether nebivolol (NEB), a vasodilatory beta(1)-selective blocker, is a safe 
      and efficacious monotherapy for individuals with systolic stage II hypertension. 
      METHODS: In 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 (alpha = 0.05). Responder analysis was also performed. 
      Safety and tolerability assessment included monitoring of adverse events (AEs). 
      RESULTS: Mean 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%). CONCLUSIONS: NEB 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.
CI  - Copyright (c) 2013 Elsevier HS Journals, Inc. All rights reserved.
FAU - Lewin, Andrew
AU  - Lewin A
AD  - National Research Institute, Los Angeles, CA 90057, USA. 
      docl@clinical-studies.com
FAU - Punzi, Henry
AU  - Punzi H
FAU - Luo, Xiaohui
AU  - Luo X
FAU - Stapff, Manfred
AU  - Stapff M
LA  - eng
SI  - ClinicalTrials.gov/NCT01057251
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20130115
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Adrenergic beta-1 Receptor Antagonists)
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Benzopyrans)
RN  - 0 (Ethanolamines)
RN  - 030Y90569U (Nebivolol)
SB  - IM
MH  - Adolescent
MH  - Adrenergic beta-1 Receptor Antagonists/administration & dosage/adverse 
      effects/*therapeutic use
MH  - Adult
MH  - Antihypertensive Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Benzopyrans/administration & dosage/adverse effects/*therapeutic use
MH  - Blood Pressure/drug effects
MH  - Double-Blind Method
MH  - Ethanolamines/administration & dosage/adverse effects/*therapeutic use
MH  - Female
MH  - Humans
MH  - Hypertension/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Nebivolol
MH  - Racial Groups
MH  - Young Adult
EDAT- 2013/01/22 06:00
MHDA- 2013/08/14 06:00
CRDT- 2013/01/22 06:00
PHST- 2012/08/03 00:00 [received]
PHST- 2012/11/20 00:00 [revised]
PHST- 2012/12/20 00:00 [accepted]
PHST- 2013/01/22 06:00 [entrez]
PHST- 2013/01/22 06:00 [pubmed]
PHST- 2013/08/14 06:00 [medline]
AID - S0149-2918(12)00730-8 [pii]
AID - 10.1016/j.clinthera.2012.12.015 [doi]
PST - ppublish
SO  - Clin Ther. 2013 Feb;35(2):142-52. doi: 10.1016/j.clinthera.2012.12.015. Epub 2013 
      Jan 15.