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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
The Valsartan Antihypertensive Long-Term Use Evaluation (VALUE) trial: Outcomes in patients receiving monotherapy
Hypertension, Volume 48, No. 3, Year 2006
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Description
In the main Valsartan Antihypertensive Long-Term Use Evaluation (VALUE) report, we investigated outcomes in 15 245 high-risk hypertensive subjects treated with valsartan- or amlodipine-based regimens. In this report, we analyzed outcomes in 7080 patients (46.4%) who, at the end of the initial drug adjustment period (6 months), remained on monotherapy. Baseline characteristics were similar in the valsartan (N=3263) and amlodipine (N=3817) groups. Time on monotherapy was 3.2 years (78% of treatment exposure time). The average in-trial blood pressure was similar in both groups. Event rates in the monotherapy group were 16% to 39% lower than in the main VALUE trial. In the first analysis, we censored patients when they discontinued monotherapy ("censored"); in the second, we counted events regardless of subsequent therapy (intention-to-treat principle). We also assessed the impact of duration of monotherapy on outcomes. No difference was found in primary composite cardiac end points, strokes, myocardial infarctions, and all-cause deaths with both analyses. Heart failure in the valsartan group was lower both in the censored and intention-to-treat analyses (hazard ratios: 0.63, P=0.004 and 0.78, P=0.045, respectively). Longer duration of monotherapy amplified between-group differences in heart failure. New-onset diabetes was lower in the valsartan group with both analyses (odds ratios: 0.78, P=0.012 and 0.82, P=0.034). Thus, despite lower absolute event rates in monotherapy patients, the relative risks of heart failure and new-onset diabetes favored valsartan. Moreover, these findings support the feasibility of comparative prospective trials in lower-risk hypertensive patients. © 2006 American Heart Association, Inc.
Authors & Co-Authors
Julius, Stevo
United States, Ann Arbor
University of Michigan, Ann Arbor
Weber, Michael A.
United States, Albany
State University of new York System
Kjeldsen, Sverre Erik
United States, Ann Arbor
University of Michigan, Ann Arbor
Norway, Oslo
Ulleval University Hospital
McInnes, Gordon T.
United Kingdom, Glasgow
University of Glasgow
Zanchetti, Alberto
Italy, Milan
Università Degli Studi Di Milano
Brunner, Hans R.
Switzerland, Lausanne
Université de Lausanne Unil
Laragh, John
United States, New York
Weill Cornell Medical Center
Schork, M. Anthony
United States, Ann Arbor
University of Michigan, Ann Arbor
Hua, Tsushung A.
Switzerland, Basel
Novartis International ag
Amerena, John V.
Australia, Geelong
Geelong Hospital
Balazovjech, Ivan
Slovakia, Kosice
Medical Faculty Hospital, Kosice
Cassel, Graham
South Africa, Johannesburg
Milpark Hospital
Herczeg, Béla
Unknown Affiliation
Koylan, Nevres
Turkey, Istanbul
Istanbul Üniversitesi
Magometschnigg, Dieter
Austria, Vienna
Institut Fur Hypertoniker, Vienna
Majahalme, Silja
United States, Appleton
Appleton Heart Institute
Martínez, Felipe A.
Argentina, Cordoba
Universidad Nacional de Córdoba
Oigman, Wille
Brazil, Rio de Janeiro
Hospital Universitario Pedro Ernesto
Gomes, Ricardo Seabra
Portugal, Carnaxide
Instituto do Coração
Zhu, Junren
China, Shanghai
Zhongshan Hospital
Statistics
Citations: 150
Authors: 20
Affiliations: 18
Identifiers
Doi:
10.1161/01.HYP.0000236119.96301.f2
ISSN:
0194911X
Research Areas
Environmental
Noncommunicable Diseases
Study Design
Cohort Study