| Efficacy and safety of nebivolol in Hispanics with stage I-II hypertension: a randomized placebo-controlled trial. | |
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MedLine Citation:
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PMID: 21088095 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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Henry Punzi; Andrew Lewin; Tatjana Lukić; Thomas Goodin; Wei Chen |
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Publication Detail:
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Type: Clinical Trial, Phase IV; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Therapeutic advances in cardiovascular disease Volume: 4 ISSN: 1753-9455 ISO Abbreviation: Ther Adv Cardiovasc Dis Publication Date: 2010 Dec |
Date Detail:
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Created Date: 2010-11-22 Completed Date: 2011-03-04 Revised Date: 2011-09-15 |
Medline Journal Info:
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Nlm Unique ID: 101316343 Medline TA: Ther Adv Cardiovasc Dis Country: England |
Other Details:
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Languages: eng Pagination: 349-57 Citation Subset: IM |
Affiliation:
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Trinity Hypertension & Metabolic Research Institute, 1932 Walnut Plaza, Carrollton, TX 75006, USA. punzimedcenter@aol.com |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult 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* Female Hispanic Americans Humans Hypertension / drug therapy* Male Middle Aged Prospective Studies Single-Blind Method Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Antihypertensive Agents; 0/Benzopyrans; 0/Ethanolamines; 99200-09-6/nebivolol |
| Comments/Corrections | |
Erratum In:
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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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