PMID- 21864908
OWN - NLM
STAT- MEDLINE
DCOM- 20120213
LR  - 20151119
IS  - 1879-114X (Electronic)
IS  - 0149-2918 (Linking)
VI  - 33
IP  - 9
DP  - 2011 Sep
TI  - Efficacy and tolerability of nebivolol in stage I-II hypertension: a pooled 
      analysis of data from three randomized, placebo-controlled monotherapy trials.
PG  - 1150-61
LID - 10.1016/j.clinthera.2011.07.020 [doi]
AB  - BACKGROUND: Nebivolol is a beta(1)-selective beta-blocker with NO-mediated vasodilatory 
      properties, approved in the United States for the treatment of stage I-II 
      hypertension. OBJECTIVE: The purpose of this pooled analysis was to summarize 
      efficacy and provide a brief overview of the tolerability associated with the use 
      of nebivolol. METHODS: PubMed was searched for randomized, double-blind, 
      placebo-controlled, parallel-group trials of monotherapy with nebivolol for stage 
      I-II hypertension of at least 12 weeks' duration. This article reports pooled 
      changes in sitting diastolic blood pressure (DBP), systolic blood pressure (SBP), 
      and heart rate (HR) at trough; proportions of responders (patients whose 
      end-point sitting DBP at trough was <90 mm Hg or whose sitting DBP at trough had 
      decreased from baseline by </=10 mm Hg); and the most frequent adverse events 
      (AEs). These data were also summarized in the subpopulation of black patients. 
      RESULTS: The literature search yielded 3 similarly designed studies. In all 3 
      trials, a single-blind placebo run-in phase (4-6 weeks) was followed by 
      randomization (baseline) and a 12-week double-blind treatment phase in which 
      patients received nebivolol 1.25 to 30 or 40 mg/d or placebo. The primary 
      efficacy measure in all 3 trials was the mean change from baseline in sitting DBP 
      at 12 weeks, based on the intent-to-treat population. In the pooled sample, 930 
      (46.1%) patients were women, and the mean age was 53.6 years. Compared with 
      placebo (n = 205), the reductions in DBP (up to 11.1 mm Hg), SBP (up to 12.4 mm 
      Hg), and HR (up to 9.2 beats/min) were significantly greater with nebivolol (n = 
      1811) at the recommended dosages of 5-30/40 mg/d (all, P < 0.001). The most 
      commonly reported AEs were headache (nebivolol, all dosages, 7.1%; placebo, 
      5.9%), fatigue (3.6% vs 1.5%, respectively), and nasopharyngitis (3.1% vs 4.4%). 
      The efficacy and tolerability of nebivolol in black patients were similar to 
      those observed in the total study population. CONCLUSION: Based on the pooled 
      results from the 3 monotherapy trials reported here, nebivolol administered for 
      12 weeks was efficacious and generally well tolerated in patients with stage I-II 
      hypertension.
CI  - Copyright (c) 2011 Elsevier HS Journals, Inc. All rights reserved.
FAU - Weiss, Robert J
AU  - Weiss RJ
AD  - Androscoggin Cardiology Associates, Auburn, Maine 04210-5967, USA. 
      rweiss@exploremaine.com
FAU - Saunders, Elijah
AU  - Saunders E
FAU - Greathouse, Mark
AU  - Greathouse M
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, Non-U.S. Gov't
DEP - 20110824
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Benzopyrans)
RN  - 0 (Ethanolamines)
RN  - 030Y90569U (Nebivolol)
SB  - IM
MH  - Antihypertensive Agents/administration & dosage/*adverse effects/*therapeutic use
MH  - Benzopyrans/administration & dosage/*adverse effects/*therapeutic use
MH  - Ethanolamines/administration & dosage/*adverse effects/*therapeutic use
MH  - Humans
MH  - Hypertension/*drug therapy
MH  - Nebivolol
MH  - Randomized Controlled Trials as Topic
MH  - Severity of Illness Index
MH  - Treatment Outcome
EDAT- 2011/08/26 06:00
MHDA- 2012/02/14 06:00
CRDT- 2011/08/26 06:00
PHST- 2011/07/25 00:00 [accepted]
PHST- 2011/08/26 06:00 [entrez]
PHST- 2011/08/26 06:00 [pubmed]
PHST- 2012/02/14 06:00 [medline]
AID - S0149-2918(11)00512-1 [pii]
AID - 10.1016/j.clinthera.2011.07.020 [doi]
PST - ppublish
SO  - Clin Ther. 2011 Sep;33(9):1150-61. doi: 10.1016/j.clinthera.2011.07.020. Epub 
      2011 Aug 24.