Population Pharmacokinetic Analysis of Enalapril and Enalaprilat in Newly Treated Children with Heart Failure: Implications for Safe Dosing of Enalapril (LENA Studies).

ABSTRACT:

Background

Enalapril orodispersible minitablets (ODMT) have been authorised by the European Medicines Agency for the treatment of heart failure in children from birth to 17 years of age in 2023. Consequently, the use of enalapril in very young and angiotensin-converting enzyme inhibitor (ACEi) naïve patients is expected to increase.

Objectives

Simultaneous characterisation of the pharmacokinetics (PK) of enalapril and the active metabolite enalaprilat in ACEi naïve children with heart failure using a combined population pharmacokinetic (PopPK) model and identification of clinically relevant covariates for the dosing of enalapril in this population.

Methods

Data of ACEi naïve subjects from the European project 'Labeling of Enalapril from Neonates up to Adolescents' (LE

SUBMITTER: Steichert M 

PROVIDER: S-EPMC12185616 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature