Published Online
on June 30, 2008

A more recent version of this article appeared on August 1, 2008

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Submitted on January 27, 2008
Revised on February 15, 2008

Efficacy and Safety of the Angiotensin Receptor Blocker Valsartan in Children With Hypertension Aged 1 to 5 Years

Joseph T. Flynn^*; Kevin E.C. Meyers; Jose Pacheco Neto; Rejane de Paula Meneses; Aleksandra Zurowska; Arvind Bagga; Lionel Mattheyse; Victor Shi; Jitendra Gupte; Susan Solar-Yohay; Guangyang Han; for the Pediatric Valsartan Study Group

From the Division of Nephrology (J.T.F.), Children's Hospital and Regional Medical Center, Seattle, Wash; Division of Nephrology (K.E.C.M.), Children's Hospital of Philadelphia, Pa; Department of Pediatrics (J.P.N.), Instituto Materno Infantil de Pernambuco, Recife, Pernambuco, Brazil; Centro de Nefrolog Ped do Parana-Hosp (R.d.P.M.), Curitibal, Brazil; Department of Pediatric and Adolescent Nephrology and Hypertension (A.Z.), Gdansk University Medical School, Gdansk, Poland; Department of Pediatrics (A.B.), All India Institute of Medical Sciences, New Delhi, India; Zuid Afrikaanse Hospital (L.M.), Muckleneuk, South Africa; and Cardiovascular Research (V.S., J.G., S.S-Y., G.H.), Novartis Pharmaceuticals Corporation, East Hanover, NJ.

^* To whom correspondence should be addressed. E-mail: joseph.flynn{at}seattlechildrens.org.

Abstract—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.

Key words: children • kidney disease • hypertension • valsartan • angiotensin receptor blocker • clinical trial

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