Population pharmacokinetics of lisinopril in hypertensive children and
adolescents with normal to mildly reduced kidney function
Abstract
Background: Lisinopril, an angiotensin-converting enzyme inhibitor
(ACEi), is a frequently prescribed antihypertensive drug in the
pediatric population, while being used off-label under the age of 6
years in the US and for all pediatric patients globally. The SAFEPEDRUG
project (IWT-130033) investigated lisinopril pharmacokinetics in
hypertensive pediatric patients corresponding with the day-to-day
clinical population. Methods: The dose-escalation pilot study included
13 children with primary and secondary hypertension who received oral
lisinopril once daily in the morning; doses ranged from 0.05mg.kg-1 to
0.2 mg.kg-1. Patients were aged between 1.9 and 17.9 years (median 13.5
years) and weight ranged between 9.62 and 97.2kg (median 53.2kg). All
data were analyzed using Monolix version 2020R1 (Lixoft®, France) and R
version 3.6.2. Results: A one-compartment model with 1st order
absorption and 1st order elimination optimally describes the data.
Parameter estimates of ka (0.077h-1 [9.6%], typical value
[relative standard error]), V/F (32.9L 70.g-1 [37%]) and CL/F
(23.1L h-1 .70kg-1[8.5%]) show good predictive ability. Significant
covariate effects include total body weight on elimination clearance,
and distribution volume and estimated glomerular filtration rate (eGFR)
on elimination clearance. The effects of eGFR on the elimination
clearance are optimally described by a power law parameterization
centered around 105 mL.min.1.73m2. The effects of body weight were
implemented using fixed allometric exponents centered around an adult
weight of 70kg. Conclusion: Lisinopril dose and regimen adjustments for
pediatric patients should include eGFR on top of weight adjustments. An
expanded model characterizing the pharmacodynamic effect is required to
identify the optimal dose and dosing regimen.