Document Detail


Effectiveness and safety of high-dose valsartan monotherapy in hypertension treatment: the ValTop study.
MedLine Citation:
PMID:  20686486     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Early combination therapy is increasingly recommended in hypertension management because of increased risk of adverse effects with high-dose monotherapy. However, this risk is not necessarily increased for high doses of angiotensin receptor blockers (ARB). ValTop study compared efficacy and safety of high vs. conventional dose of valsartan in hypertensive patients. ValTop was a controlled, randomized, double-blind trial. Of 6035 screened subjects, 4004 mild-to-moderate hypertensive patients (mean seated diastolic blood pressure (MSDBP) 90-109 mm Hg) started 4-week open-label treatment with valsartan 160 mg. Of them, 3776 were randomized to receive valsartan 160 mg (N=1900) or 320 mg (N=1876) o.d. for 4 weeks. In 28-week open-label extension study, all participating patients (N=642) received valsartan 320 mg. Valsartan 160 mg reduced MSDBP by 10.0 mm Hg in the initial open-label phase. Further BP reductions in the double-blind phase were significantly (P<0.0001) greater in the 320 mg group than in the 160 mg group for MSDBP (1.6 ± 0.18 mm Hg vs. 0.5 ± 0.18 mm Hg) and mean seated systolic BP (3.3 ± 0.31 mm Hg vs. 0.7 ± 0.31 mm Hg). The size of the additional effect of the 320 mg dose on BP was similar in subjects controlled or not by the initial 160 mg dose. Adverse event (AE) rates were similar in both treatment groups, drug-related AEs occurring in <5% of subjects in each phase. High-dose valsartan is safe and effective in uncomplicated mild-to-moderate hypertension independently of the initial response to a moderate dose. High-dose ARB monotherapy may thus be a viable option in hypertension management.
Authors:
Gianfranco Parati; Roland Asmar; Grzegorz Bilo; Albert Kandra; Robert Di Giovanni; Thomas Mengden
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2010-08-05
Journal Detail:
Title:  Hypertension research : official journal of the Japanese Society of Hypertension     Volume:  33     ISSN:  1348-4214     ISO Abbreviation:  Hypertens. Res.     Publication Date:  2010 Oct 
Date Detail:
Created Date:  2010-10-05     Completed Date:  2011-02-01     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9307690     Medline TA:  Hypertens Res     Country:  England    
Other Details:
Languages:  eng     Pagination:  986-94     Citation Subset:  IM    
Affiliation:
Department of Clinical Medicine and Prevention, University of Milano-Bicocca, Milan, Italy. gianfranco.parati@unimib.it
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MeSH Terms
Descriptor/Qualifier:
Aged
Angiotensin II Type 1 Receptor Blockers / adverse effects,  therapeutic use*
Blood Pressure / physiology
Dose-Response Relationship, Drug
Double-Blind Method
Female
Humans
Hypertension / drug therapy*,  physiopathology
Male
Middle Aged
Severity of Illness Index
Tetrazoles / adverse effects,  therapeutic use*
Treatment Outcome
Valine / adverse effects,  analogs & derivatives*,  therapeutic use
Chemical
Reg. No./Substance:
0/Angiotensin II Type 1 Receptor Blockers; 0/Tetrazoles; 137862-53-4/valsartan; 7004-03-7/Valine
Comments/Corrections
Comment In:
Hypertens Res. 2010 Oct;33(10):981-3   [PMID:  20720555 ]

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


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