Pharmacokinetics, Safety Profile, and Efficacy of Aliskiren in Pediatric Patients With Hypertension. (July 2013)

• Record Type: Journal Article
• Authors: Sullivan, Janice E.; Keefe, Deborah; Zhou, Yinong; Satlin, Lisa; Fang, Hui; Yan, Jing-He
• Is Part Of: Clinical pediatrics. Volume 52:Number 7(2013)
• Page Start: 599
• Page End: 607
• Publication Date: 2013-07
• Subjects: aliskiren -- pediatric hypertension -- pharmacokinetics -- blood pressure; Pediatrics -- Periodicals; 618.920005
• DOI: 10.1177/0009922813483875
• Languages: English
• ISSNs: 0009-9228

Abstract

Objective . To assess the pharmacokinetics (PK) and safety profile of aliskiren in pediatric patients (6-17 years old) with hypertension. Methods . Patients were randomized to a single weight-based dose of either 2 mg/kg (n = 19) or 6 mg/kg (n = 20) of aliskiren daily for 8 days. The PK, pharmacodynamics, safety profile, and efficacy of aliskiren were assessed. Results . Of the 39 randomized patients, 37 (94.9%) completed the study. Aliskiren plasma concentration (maximum plasma concentration and area under the plasma concentration–time curve) increased dose dependently, achieving peak concentrations in 1 to 2 hours, and t max was comparable across the dose and age groups. Treatment-emergent adverse events (AEs) were reported in 18 (46.2%) patients, with headache, abdominal pain, and nausea being the most frequent. Conclusions . Aliskiren 2 mg/kg and 6 mg/kg daily showed dose-dependent increases in the plasma concentration. The drug was well tolerated in hypertensive children aged 6 to 17 years. AEs were generally mild and not related to either the drug or the dose.