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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Efficacy and safety of the angiotensin receptor blocker valsartan in children with hypertension aged 1 to 5 years
Hypertension, Volume 52, No. 2, Year 2008
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Description
The efficacy and safety of valsartan were studied in 90 children (mean age: 3.2 years; 60% male; 30% black) with systolic blood pressure (SBP) ≥95th percentile. Nineteen percent received valsartan in addition to previous antihypertensive therapy. Subjects were randomly assigned to low-, medium-, or high-dose valsartan for 2 weeks (phase 1) and then reassigned randomly to placebo or to remain on the same valsartan dose for 2 additional weeks (phase 2). After this, subjects were enrolled into a 52-week, open-label phase during which valsartan was dosed to achieve SBP <95th percentile. Statistically significant reductions in SBP and diastolic blood pressure of ≈8.5 mm Hg and 5.7 mm Hg, respectively, were observed at the end of phase 1 in all of the valsartan dose groups. SBP and diastolic blood pressure were also significantly lower during phase 2 in valsartan recipients compared with placebo recipients. SBP <95th percentile was achieved in 77.3% of subjects during the open-label phase. Adverse events were minor and occurred at similar frequencies in each of the 3 dose groups in phase 1 and at equal frequencies in the valsartan and placebo arms in phase 2. Serious adverse events and drug-related adverse events occurred infrequently during both the double-blind (2.2% and 5.6%, respectively) and open-label (14.8% and 6.8%, respectively) portions of the study. Valsartan treatment had no demonstrable negative effects on growth and development. In this study, the first trial of an antihypertensive agent conducted in children <6 years of age, valsartan effectively lowered SBP and diastolic blood pressure compared with placebo. © 2008 American Heart Association, Inc.
Authors & Co-Authors
Flynn, Joseph Thomas
United States, Seattle
Children's Hospital and Regional Medical Center
Meyers, Kevin E.C.
United States, Philadelphia
The Children's Hospital of Philadelphia
Neto, Jose Pacheco R
Brazil, Recife
Instituto Materno Infantil
de Paula Meneses, Rejane
Brazil
Centro de Nefrolog Ped do Parana-hosp
Żurowska, Aleksandra M.
Poland, Gdansk
Gdanski Uniwersytet Medyczny
Bagga, Arvind
India, New Delhi
All India Institute of Medical Sciences, new Delhi
Mattheyse, Lionel
South Africa, Muckleneuk, Pretoria
Zuid-afrikaanse Hospital
Shi, Victor C.
Switzerland, Basel
Novartis International ag
Gupte, Jitendra
Switzerland, Basel
Novartis International ag
Solar-Yohay, Susan
Switzerland, Basel
Novartis International ag
Han, Guangyang
Switzerland, Basel
Novartis International ag
Statistics
Citations: 82
Authors: 11
Affiliations: 8
Identifiers
Doi:
10.1161/HYPERTENSIONAHA.108.111054
ISSN:
0194911X
Research Areas
Disability
Maternal And Child Health
Noncommunicable Diseases
Participants Gender
Male