PMID- 23610239
OWN - NLM
STAT- MEDLINE
DCOM- 20140206
LR  - 20130604
IS  - 1938-2707 (Electronic)
IS  - 0009-9228 (Linking)
VI  - 52
IP  - 7
DP  - 2013 Jul
TI  - Pharmacokinetics, safety profile, and efficacy of aliskiren in pediatric patients 
      with hypertension.
PG  - 599-607
LID - 10.1177/0009922813483875 [doi]
AB  - 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.
FAU - Sullivan, Janice E
AU  - Sullivan JE
AD  - University of Louisville, Kosair Charities Pediatric Clinical Research Unit and 
      Kosair Children's Hospital, Louisville, KY 40202, USA. sully@louisville.edu
FAU - Keefe, Deborah
AU  - Keefe D
FAU - Zhou, Yinong
AU  - Zhou Y
FAU - Satlin, Lisa
AU  - Satlin L
FAU - Fang, Hui
AU  - Fang H
FAU - Yan, Jing-He
AU  - Yan JH
LA  - eng
SI  - ClinicalTrials.gov/NCT00834041
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20130422
PL  - United States
TA  - Clin Pediatr (Phila)
JT  - Clinical pediatrics
JID - 0372606
RN  - 0 (Amides)
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Fumarates)
RN  - 0 (Tablets)
RN  - 502FWN4Q32 (aliskiren)
SB  - IM
MH  - Administration, Oral
MH  - Adolescent
MH  - Age Factors
MH  - Amides/adverse effects/blood/*pharmacokinetics/*therapeutic use
MH  - Analysis of Variance
MH  - Antihypertensive Agents/adverse effects/*pharmacokinetics/*therapeutic use
MH  - Child
MH  - Dose-Response Relationship, Drug
MH  - Drug Administration Schedule
MH  - Female
MH  - Fumarates/adverse effects/blood/*pharmacokinetics/*therapeutic use
MH  - Humans
MH  - Hypertension/*drug therapy
MH  - Male
MH  - Regression Analysis
MH  - Tablets
MH  - Treatment Outcome
OTO - NOTNLM
OT  - aliskiren
OT  - blood pressure
OT  - pediatric hypertension
OT  - pharmacokinetics
EDAT- 2013/04/24 06:00
MHDA- 2014/02/07 06:00
CRDT- 2013/04/24 06:00
PHST- 2013/04/24 06:00 [entrez]
PHST- 2013/04/24 06:00 [pubmed]
PHST- 2014/02/07 06:00 [medline]
AID - 0009922813483875 [pii]
AID - 10.1177/0009922813483875 [doi]
PST - ppublish
SO  - Clin Pediatr (Phila). 2013 Jul;52(7):599-607. doi: 10.1177/0009922813483875. Epub 
      2013 Apr 22.