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Clin Pharmacol Ther. 2015 Jul;98(1):25-33. doi: 10.1002/cpt.127. Epub 2015 May 2.

Pharmacokinetics, Pharmacodynamics, and Safety of Lisinopril in Pediatric Kidney Transplant Patients: Implications for Starting Dose Selection.

Author information

1
Department of Pediatrics, New York University, New York, New York, USA.
2
Department of Pediatrics, Stanford University, Palo Alto, California, USA.
3
Emmes Corp., Rockville, Maryland, USA.
4
Department of Pediatric Nephrology, Emory University, Atlanta, Georgia, USA.
5
Division of Pediatric Nephrology, University of Alabama, Birmingham, Alabama, USA.
6
Department of Pediatrics, University of Michigan, Ann Arbor, Michigan, USA.
7
Department of Pediatrics, Children's Mercy Hospital, Kansas City, Missouri, USA.
8
Division of Nephrology and Hypertension, Cincinnati Children's Hospital, Cincinnati, Ohio, USA.
9
Division of Pediatric Nephrology, University of Rochester, Rochester, New York, USA.
10
OpAns, LLC, Durham, North Carolina, USA.
11
Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina, USA.

Abstract

Hypertension in pediatric kidney transplant recipients contributes to long-term graft loss, yet treatment options--including angiotensin-converting enzyme inhibitors--are poorly characterized in this vulnerable population. We conducted a multicenter, open-label pharmacokinetic (PK) study of daily oral lisinopril in 22 children (ages 7-17 years) with stable kidney transplant function. Standard noncompartmental PK analyses were performed at steady state. Effects on blood pressure were examined in lisinopril-naïve patients (n = 13). Oral clearance declined in proportion to underlying kidney function; however, in patients with low estimated glomerular filtration rate (30-59 ml/min per 1.73m(2)), exposure (standardized to 0.1 mg/kg/day dose) was within the range reported previously in children without a kidney transplant. In lisinopril-naïve patients, 85% and 77% had a ≥ 6 mmHg reduction in systolic and diastolic blood pressure, respectively. Lisinopril was well tolerated. Our study provides initial insight on lisinopril use in children with a kidney transplant, including starting dose considerations.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01491919.

PMID:
25807932
PMCID:
PMC4536255
DOI:
10.1002/cpt.127
[Indexed for MEDLINE]
Free PMC Article

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