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Assistant Professor, Department of Pharmacy Practice, College of Pharmacy, University of Arkansas for Medical Sciences, Little Rock, AR
Clinical Pharmacology Fellow, Department of Pharmacy Practice, College of Pharmacy, University of Arkansas for Medical Sciences
Associate Professor and Associate Dean for Academic Affairs, College of Pharmacy, University of Arkansas for Medical Sciences
Professor, Department of Pediatrics, Section of Clinical Pediatric Pharmacology and Toxicology, University of Arkansas for Medical Sciences; Arkansas Children's Hospital, Little Rock
Professor and Dean, College of Pharmacy, University of Arkansas for Medical Sciences
Reprints: Dr. Franks, 4301 W. Markham St., #522, Little Rock, AR 72205, fax 501/296-1168, AFranks{at}uams.edu
BACKGROUND: The angiotensin-receptor blocker candesartan cilexetil is a well-tolerated antihypertensive agent with demonstrated benefits in adults with hypertension. However, there are few data supporting its use in children with hypertension.
OBJECTIVE: To determine the efficacy and tolerability of candesartan cilexetil in the treatment of pediatric hypertension.
METHODS: In an open-label, uncontrolled pilot study, hypertensive pediatric patients were eligible for participation if untreated systolic and/or diastolic blood pressure (BP) exceeded the 95th percentile for sex, age, and height. Patients underwent a 7-day washout period prior to initiation of weight-based dosing of candesartan cilexetil (2–8 mg daily). The dose was doubled after 7 days of therapy if inadequate antihypertensive response was determined by clinic-measured casual BP monitoring (CBPM) and home BP monitoring (HBPM). Three methods of BP measurement were compared before and after 2 weeks of treatment with the final dose of candesartan cilexetil: CBPM, HBPM, and 24-hour continuous ambulatory BP monitoring (ABPM). Self-reported adverse effects and clinical laboratory analyses were used to determine tolerability.
RESULTS: Eleven patients (mean age 14.2 y) received a final candesartan cilexetil median daily dose of 8 mg (0.13 mg/kg, range 2–16 mg). Study treatment resulted in significant reductions in systolic and diastolic BP as measured by CBPM (–7.4%, p = 0.03 and –5.9%, p = 0.01, respectively) and by ABPM (–6.0%, p = 0.03 and –10.8%, p = 0.006, respectively), but no significant reductions as measured by HBPM. No clinically significant changes in laboratory measures were observed, and patients reported nonspecific mild adverse effects.
CONCLUSIONS: Candesartan cilexetil effectively reduced BP as demonstrated by CBPM and ABPM measurements and was well tolerated in this group of hypertensive children.
Key Words: blood pressure, candesartan cilexetil, children, hypertension
Published Online, July 29, 2008. www.theannals.com, DOI 10.1345/aph.1L212