title: Effectiveness and safety of valsartan in children aged 6 to 16 years with hypertension.
abstract: The effectiveness and safety of valsartan have not been assessed in hypertensive children. Therefore, hypertensive patients aged 6 to 16 years (n=261) were randomized to receive weight-stratified low- (10/20 mg), medium- (40/80 mg), or high-dose (80/160 mg) valsartan for 2 weeks. After 2 weeks, patients were randomized to a 2-week placebo-controlled withdrawal phase. Dose-dependent reductions in sitting systolic blood pressure (SSBP) and sitting diastolic blood pressure (SDBP) were observed after 2 weeks (low dose, -7.9/-4.6 mm Hg; medium dose, -9.6/-5.8 mm Hg; high dose, -11.5/-7.4 mm Hg [P<.0001 for all groups]). During the withdrawal phase, SSBP and SDBP were both lower in the pooled valsartan group than in the pooled placebo group (SSBP, -2.7 mm Hg [P=.0368]; SDBP, -3.0 mm Hg [P=.0047]). Similar efficacy was observed in all subgroups. Valsartan was well tolerated and headache was the most commonly observed adverse event during both the double-blind and 52-week open-label phases.
authors.affiliation: University of Arkansas for Medical Sciences, Arkansas Children's Hospital, Little Rock, AR, USA.
authors.forename: Thomas
authors.initials: T
authors.lastname: Wells
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Blumer
authors.forename: Kevin E C
authors.initials: KE
authors.lastname: Meyers
authors.forename: Jose P R
authors.initials: JP
authors.lastname: Neto
authors.forename: Rejane
authors.initials: R
authors.lastname: Meneses
authors.forename: Mieczysław
authors.initials: M
authors.lastname: Litwin
authors.forename: Johan
authors.initials: J
authors.lastname: Vande Walle
authors.forename: Susan
authors.initials: S
authors.lastname: Solar-Yohay
authors.forename: Victor
authors.initials: V
authors.lastname: Shi
authors.forename: Guangyang
authors.initials: G
authors.lastname: Han
mesh_terms: D000293:Adolescent; D047228:Angiotensin II Type 1 Receptor Blockers / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects / Q000502:physiology; D002648:Child; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006261:Headache / Q000139:chemically induced / Q000453:epidemiology; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000503:physiopathology; D015994:Incidence; D008137:Longitudinal Studies; D008297:Male; D011446:Prospective Studies; D013777:Tetrazoles / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use*; D016896:Treatment Outcome; D014633:Valine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D000068756:Valsartan
chemical_list: D047228:Angiotensin II Type 1 Receptor Blockers; D013777:Tetrazoles; D000068756:Valsartan; D014633:Valine