Document Detail

Efficacy and safety of nebivolol in Hispanics with stage I-II hypertension: a randomized placebo-controlled trial.
MedLine Citation:
PMID:  21088095     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: Hispanics have lower rates of hypertension control compared with black and white patients. Nebivolol is a vasodilatory β1-selective blocker, with neutral metabolic effects. This phase IV trial evaluated the efficacy and safety of nebivolol in Hispanics with stage I-II hypertension.
METHODS: Self-identified Hispanics with stage I-II hypertension were randomized to receive a double-blind treatment: placebo (n = 136) or nebivolol (n = 141, starting dose 5 mg/day) for 8 weeks. Nebivolol dosage could be uptitrated at 2-week intervals to 10, 20, or 40 mg/day, as needed to achieve diastolic blood pressure (DBP) control (JNC7 criteria). Efficacy outcome measures were the mean changes from baseline to the end of week 8 in trough-seated DBP (primary) and systolic blood pressure (SBP) (secondary). Safety and tolerability were also assessed.
RESULTS: Baseline SBP/DBP (mmHg) was similar in both treatment groups (nebivolol: 156/100; placebo: 157/101). A total of 135 (96%) and 121 (89%) nebivolol- and placebo-treated participants completed the double-blind phase, respectively. Compared with the placebo, nebivolol treatment was associated with significant mean reductions in both trough-seated DBP and SBP (DBP: -11.1 mmHg vs. -7.3 mmHg, p < 0.0001; SBP: -14.1 mmHg vs. -9.3 mmHg; p = 0.001). Treatment-emergent adverse event (TEAE) rates were 17% (nebivolol) and 22% (placebo); the most frequent TEAEs were headache (4% vs. 6%, respectively), upper respiratory tract infection (2% vs. 2%), and dizziness (1% vs. 3%).
CONCLUSIONS: In Hispanics with stage I-II hypertension, 8-week nebivolol monotherapy resulted in significant reductions in blood pressure. The safety and tolerability profile of nebivolol was similar to that of placebo.
Henry Punzi; Andrew Lewin; Tatjana Lukić; Thomas Goodin; Wei Chen
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Publication Detail:
Type:  Clinical Trial, Phase IV; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Therapeutic advances in cardiovascular disease     Volume:  4     ISSN:  1753-9455     ISO Abbreviation:  Ther Adv Cardiovasc Dis     Publication Date:  2010 Dec 
Date Detail:
Created Date:  2010-11-22     Completed Date:  2011-03-04     Revised Date:  2011-09-15    
Medline Journal Info:
Nlm Unique ID:  101316343     Medline TA:  Ther Adv Cardiovasc Dis     Country:  England    
Other Details:
Languages:  eng     Pagination:  349-57     Citation Subset:  IM    
Trinity Hypertension & Metabolic Research Institute, 1932 Walnut Plaza, Carrollton, TX 75006, USA.
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MeSH Terms
Antihypertensive Agents / administration & dosage,  adverse effects,  therapeutic use*
Benzopyrans / administration & dosage,  adverse effects,  therapeutic use*
Blood Pressure / drug effects*
Dose-Response Relationship, Drug
Double-Blind Method
Ethanolamines / administration & dosage,  adverse effects,  therapeutic use*
Hispanic Americans
Hypertension / drug therapy*
Middle Aged
Prospective Studies
Single-Blind Method
Treatment Outcome
Reg. No./Substance:
0/Antihypertensive Agents; 0/Benzopyrans; 0/Ethanolamines; 99200-09-6/nebivolol
Erratum In:
Ther Adv Cardiovasc Dis. 2011 Aug;5(4):213

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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