Efficacy and safety of valsartan in hypertensive children 6 months to 5 years of age.
J Hypertens
; 31(5): 993-1000, 2013 May.
Article
en En
| MEDLINE
| ID: mdl-23511339
ABSTRACT
OBJECTIVE:
To evaluate a dose-dependent reduction in blood pressure (BP) and overall safety of valsartan in hypertensive children.METHOD:
In a multicenter, randomized, double-blind, parallel-group study, 75 patients with a documented history of hypertension were randomized (2ââ1ââ2) to receive valsartan (0.25, 1 or 4 âmg/kg per day) for 6 weeks, then rerandomized (1ââ1) to receive placebo or valsartan for 2 weeks. This followed the 18-week extension study in which all patients received open-label valsartan (1â mg/kg initial dose, titratable up to 4 âmg/kg). The primary endpoint was the slope analysis of the dose-response curve for mean sitting SBP (MSSBP) derived through MSSBP reduction over the first 6 weeks. Safety was assessed in terms of adverse events and serious adverse events (SAEs).RESULTS:
At Week 6, significant reductions in MSSBP (Pâ<â0.05) from baseline were observed for all three valsartan doses. Greater reductions were observed with the medium and high doses, although the dose-response trend was not statistically significant (Pâ=â0.099). At Week 8, a greater increase in BP was observed in patients who switched from valsartan to placebo; the difference was not significant. At the extension endpoint, MSSBP was comparable to that observed at Week 6 of the core study. Overall, valsartan was well tolerated with no dose-dependent increase in adverse events during the dose-ranging period (Week 0-6) and a comparable incidence of adverse events to placebo during the placebo withdrawal period (Week 7-8).CONCLUSION:
Although a dose-response trend was observed, statistical significance was not achieved during the dose ranging (primary endpoint) or the placebo-withdrawal periods of the study. However, valsartan demonstrated significant reductions in BP compared with baseline and provided consistent reductions over 26 weeks.
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Tetrazoles
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Valina
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Bloqueadores del Receptor Tipo 1 de Angiotensina II
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Hipertensión
/
Antihipertensivos
Tipo de estudio:
Clinical_trials
Límite:
Child, preschool
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Female
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Humans
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Infant
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Male
Idioma:
En
Revista:
J Hypertens
Año:
2013
Tipo del documento:
Article
País de afiliación:
Alemania