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Erschienen in:
01.06.2012 | Adis Drug Profile
Valsartan
In Children and Adolescents with Hypertension
Erschienen in: Pediatric Drugs | Ausgabe 3/2012
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Valsartan is an oral angiotensin II subtype 1 receptor antagonist with well established antihypertensive efficacy in adults. It is now approved in the EU and the US for the treatment of hypertension in children and adolescents.
In two, randomized, double-blind trials, a once-daily regimen of valsartan reduced the blood pressure (BP) of children and adolescents with hypertension.
In one trial in hypertensive children and adolescents aged 6–16 years, significant dose-dependent reductions from baseline in mean sitting systolic BP (msSBP) were observed for recipients of valsartan following 2 weeks’ treatment (primary endpoint). There were corresponding dose-dependent and significant reductions in mean sitting diastolic BP.
Following 2 further weeks of treatment, the reduction in msSBP was maintained in patients who were re-randomized to continue receiving the same dosage of valsartan but not in those re-randomized to placebo.
In the other trial in hypertensive children and adolescents aged 6–17 years, valsartan was no less effective than enalapril in reducing BP. Following 12 weeks’ treatment, the least square mean reduction from baseline in msSBP (primary endpoint) in recipients of valsartan was noninferior to that in recipients of enalapril.
In addition, the proportion of patients achieving an msSBP <95th percentile for age, sex, and height at week 12 was not significantly different between recipients of valsartan and enalapril (67% vs 70%). Treatment with valsartan for up to 52 weeks was well tolerated in children and adolescents with hypertension.