Document Detail


Nationwide efficacy-safety study of nebivolol in mildly hypertensive patients.
MedLine Citation:
PMID:  16772759     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Nebivolol has been adequately tested in clinical efficacy trials of patients with mild hypertension. Clinical efficacy trials or their meta-analyses did not accurately predict the outcome of subsequent large studies. The primary objective was to assess the efficacy/safety of nebivolol 5-10 mg daily in a nationwide study of patients with mild hypertension. Secondary objectives were (1) to compare efficacy/safety as monotherapy versus add-on therapy and (2) to assess the effect of nebivolol on ISH. This was an open-label, 6-week follow-up study of 6,356 patients with mild hypertension or ISH, as defined by the 1999 World Health Organization guidelines, recruited from 2,700 facilities. Previous monotherapies were continued except for beta-blockers. Results are reported as means+/-SDs. Intention-to-treat analysis is given. A total of 5,740 patients completed the study; of the withdrawals, 90% were lost for follow-up or were noncompliant, 38% were untreated before, 23% had beta-blockers. In the accumulated data, mean systolic and diastolic blood pressures fell by 24+/-14 and 13+/-9 mm Hg (both P<0.001). The differences between the blood pressure-reducing effects of nebivolol monotherapy and add-on therapy were not statistically significant: 28+/-16 and 22+/-14 mm Hg for systolic and 15+/-11 and 11+/-8 mm Hg for diastolic blood pressures. Adverse events were limited to 0.5% of the patients, no serious adverse events were observed. In the ISH patients, diastolic blood pressure fell by 4+/-6 mm Hg compared with 15+/-10 mm Hg in the no-ISH patients (P<0.01). Efficacy-safety effects of nebivolol in patients with mild hypertension can be generalized in a nationwide assessment. The efficacy of nebivolol as monotherapy and as the efficacy as add-on therapy are very similar. Nebivolol is highly efficacious in patients with ISH.
Authors:
T J Cleophas; R Agrawal; A Lichtenthal; W Mäkel; F Fici
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study    
Journal Detail:
Title:  American journal of therapeutics     Volume:  13     ISSN:  1075-2765     ISO Abbreviation:  Am J Ther     Publication Date:    2006 May-Jun
Date Detail:
Created Date:  2006-06-14     Completed Date:  2006-10-19     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9441347     Medline TA:  Am J Ther     Country:  United States    
Other Details:
Languages:  eng     Pagination:  192-7     Citation Subset:  IM    
Affiliation:
Department Medicine, Albert Schweitzer Hospital, Dordrecht, Netherlands. ajm.cleophas@wxs.nl
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MeSH Terms
Descriptor/Qualifier:
Adrenergic beta-Antagonists / therapeutic use*
Ambulatory Care Facilities
Antihypertensive Agents / adverse effects,  therapeutic use*
Benzopyrans / adverse effects,  therapeutic use*
Blood Pressure / drug effects
Ethanolamines / adverse effects,  therapeutic use*
Female
Germany
Heart Rate / drug effects
Humans
Hypertension / drug therapy*
Male
Middle Aged
Chemical
Reg. No./Substance:
0/Adrenergic beta-Antagonists; 0/Antihypertensive Agents; 0/Benzopyrans; 0/Ethanolamines; 99200-09-6/nebivolol

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


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