on July 19, 2004
Published online before print July 19, 2004, doi: 10.1161/01.HYP.0000138069.68413.f0
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Submitted on March 23, 2004
From the Duke Clinical Research Institute (J.S.L., K.B., R.K., R.M.C.), Duke University Medical Center, Durham, NC; Impact Clinical Trials (L.H.), Los Angeles, Calif; University of Texas at Houston Medical School (R.P.), Houston; Medical City Dallas Hospital (R.H.), Tex; Northwest Pediatric Kidney Specialists (R.D.J.), Portland, Ore; Children’s Hospital of Pittsburgh (P.K.), Pa; Pediatric Cardiology (C.M.C), PSC, Lexington, Ky; Children’s Hospital of Michigan (T.K.M.), Detroit; Smolensk State Medical Academy (L.Z., L.K.), Russia; Western Galilee Hospital (I.W.), Nahariya, Israel; and Bristol-Myers Squibb Company (D.D.), Princeton, NJ. * To whom correspondence should be addressed. E-mail: li000001{at}mc.duke.edu.
Abstract--We evaluated the efficacy, safety, and dose-response relationship of fosinopril in children aged 6 to 16 years with hypertension or high-normal blood pressure with an associated medical condition requiring treatment. The study was a prospective, double-blind, placebo-controlled trial conducted in 78 clinical sites in the United States, Russia, and Israel. There were 4 phases: a screening phase of 10 days maximum, a 4-week dose-response phase, a placebo withdrawal phase of 2 weeks maximum, and a 52-week open-label safety phase. The primary objective of the dose-response phase was to determine whether low (0.1 mg/kg), medium (0.3 mg/kg), or high (0.6 mg/kg) doses of fosinopril based on established adult dosing affect trough seated systolic blood pressure. During the dose-response phase, all 3 doses were equally effective in lowering systolic blood pressure. During the placebo withdrawal phase, there was an adjusted mean systolic blood pressure increase of 5.2 mm Hg for the placebo group and 1.5 mm Hg for the fosinopril group, a net withdrawal effect of 3.7 mm Hg (P=0.013). Fosinopril was well tolerated; serious adverse events occurred infrequently and were generally not attributed to fosinopril. Because children appear to be more sensitive to lower doses of fosinopril than adults, starting doses for children should be
Revised on April 8, 2004
Is the Extrapolated Adult Dose of Fosinopril Safe and Effective in Treating Hypertensive Children?
Jennifer S. Li*;
0.1 mg/kg.
Key words: fosinopril • children • blood pressure • hypertension, arterial
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