Fixed Dosing of Leuprolide Acetate, a GnRH Agonist, in Children with Central Precocious Puberty: A Population Pharmacokinetic Justification.
2/5 보강
TL;DR
The developed model adequately characterized leuprolide pharmacokinetics in pediatrics, supporting the use of a fixed leuprolide dose in pediatrics and evaluating covariate effects on leuprolide pharmacokinetics, and assessing flat-dosing feasibility in pediatrics.
PICO 자동 추출 (휴리스틱, conf 2/4)
유사 논문P · Population 대상 환자/모집단
48 patients (aged 1-10 years) were collected over 24 weeks following the administration of 11.
I · Intervention 중재 / 시술
추출되지 않음
C · Comparison 대조 / 비교
추출되지 않음
O · Outcome 결과 / 결론
No significant covariate effects were observed, supporting the use of a fixed leuprolide dose in pediatrics. [CLINICAL TRIAL REGISTRATION] NCT00635817, registered 13 March, 2008.
OpenAlex 토픽 ·
Hypothalamic control of reproductive hormones
Growth Hormone and Insulin-like Growth Factors
Prostate Cancer Diagnosis and Treatment
The developed model adequately characterized leuprolide pharmacokinetics in pediatrics, supporting the use of a fixed leuprolide dose in pediatrics and evaluating covariate effects on leuprolide pharm
APA
Chay Ngee Lim, Omar N. Al Yacoub, et al. (2026). Fixed Dosing of Leuprolide Acetate, a GnRH Agonist, in Children with Central Precocious Puberty: A Population Pharmacokinetic Justification.. Paediatric drugs, 28(3), 295-305. https://doi.org/10.1007/s40272-025-00733-2
MLA
Chay Ngee Lim, et al.. "Fixed Dosing of Leuprolide Acetate, a GnRH Agonist, in Children with Central Precocious Puberty: A Population Pharmacokinetic Justification.." Paediatric drugs, vol. 28, no. 3, 2026, pp. 295-305.
PMID
41824265 ↗
Abstract 한글 요약
[BACKGROUND] Central precocious puberty is the early onset of puberty due to premature activation of the hypothalamic-pituitary-gonadal axis, which can reduce adult height. Leuprolide, a gonadotropin-releasing hormone agonist, reduces gonadotropin secretion and is the standard treatment for central precocious puberty.
[OBJECTIVE] This study aimed to build a population model to describe the pharmacokinetics of a 3-month leuprolide acetate depot formulation in pediatric patients with central precocious puberty, evaluate covariate effects (age and weight) on leuprolide pharmacokinetics, and assess flat-dosing feasibility in pediatrics.
[METHODS] Samples from 48 patients (aged 1-10 years) were collected over 24 weeks following the administration of 11.25 and 30 mg of a leuprolide acetate 3-month depot formulation. A population pharmacokinetic model was developed using non-linear mixed-effects modeling (NONMEM). Covariate effects were tested using a forward inclusion and backward elimination approach and exploratory data analysis.
[RESULTS] A one-compartment model with immediate and delayed first-order absorption and proportional error model best described leuprolide pharmacokinetics in children. A transit compartment model characterized the delayed absorption. Apparent clearance and volume estimates were 181 L/day and 7.11 L, respectively, which were in alignment with those estimated in adult patients with prostate cancer. The immediate and delayed absorption rate constants were 0.441 day and 0.00879 day, respectively. The number of transit compartments and the mean transit time were 3 and 34.1 days, respectively. No covariates significantly affected leuprolide pharmacokinetics.
[CONCLUSIONS] The developed model adequately characterized leuprolide pharmacokinetics in pediatrics. No significant covariate effects were observed, supporting the use of a fixed leuprolide dose in pediatrics.
[CLINICAL TRIAL REGISTRATION] NCT00635817, registered 13 March, 2008.
[OBJECTIVE] This study aimed to build a population model to describe the pharmacokinetics of a 3-month leuprolide acetate depot formulation in pediatric patients with central precocious puberty, evaluate covariate effects (age and weight) on leuprolide pharmacokinetics, and assess flat-dosing feasibility in pediatrics.
[METHODS] Samples from 48 patients (aged 1-10 years) were collected over 24 weeks following the administration of 11.25 and 30 mg of a leuprolide acetate 3-month depot formulation. A population pharmacokinetic model was developed using non-linear mixed-effects modeling (NONMEM). Covariate effects were tested using a forward inclusion and backward elimination approach and exploratory data analysis.
[RESULTS] A one-compartment model with immediate and delayed first-order absorption and proportional error model best described leuprolide pharmacokinetics in children. A transit compartment model characterized the delayed absorption. Apparent clearance and volume estimates were 181 L/day and 7.11 L, respectively, which were in alignment with those estimated in adult patients with prostate cancer. The immediate and delayed absorption rate constants were 0.441 day and 0.00879 day, respectively. The number of transit compartments and the mean transit time were 3 and 34.1 days, respectively. No covariates significantly affected leuprolide pharmacokinetics.
[CONCLUSIONS] The developed model adequately characterized leuprolide pharmacokinetics in pediatrics. No significant covariate effects were observed, supporting the use of a fixed leuprolide dose in pediatrics.
[CLINICAL TRIAL REGISTRATION] NCT00635817, registered 13 March, 2008.
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