title: Pharmacokinetics, safety profile, and efficacy of aliskiren in pediatric patients with hypertension.
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.
authors.affiliation: University of Louisville, Kosair Charities Pediatric Clinical Research Unit and Kosair Children's Hospital, Louisville, KY 40202, USA. sully@louisville.edu
authors.forename: Janice E
authors.initials: JE
authors.lastname: Sullivan
authors.forename: Deborah
authors.initials: D
authors.lastname: Keefe
authors.forename: Yinong
authors.initials: Y
authors.lastname: Zhou
authors.forename: Lisa
authors.initials: L
authors.lastname: Satlin
authors.forename: Hui
authors.initials: H
authors.lastname: Fang
authors.forename: Jing-He
authors.initials: JH
authors.lastname: Yan
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000367:Age Factors; D000577:Amides / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics* / Q000627:therapeutic use*; D000704:Analysis of Variance; D000959:Antihypertensive Agents / Q000009:adverse effects / Q000493:pharmacokinetics* / Q000627:therapeutic use*; D002648:Child; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005650:Fumarates / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics* / Q000627:therapeutic use*; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D008297:Male; D012044:Regression Analysis; D013607:Tablets; D016896:Treatment Outcome
chemical_list: D000577:Amides; D000959:Antihypertensive Agents; D005650:Fumarates; D013607:Tablets; C446481:aliskiren
keywords: aliskiren; blood pressure; pediatric hypertension; pharmacokinetics