enalapril orodispersible minitablet / Ethicare - LARVOL DELTA

Angiotensin II/Angiotensin I Ratio as a New Pharmacodynamic Parameter for Population Modelling in Healthy Adults and Children with Heart Failure Treated with Enalapril. (PubMed, Pharmaceutics) - "Background/Objectives: Since 2023, enalapril orodispersible minitablets have been approved in Europe for paediatric heart failure from birth, but no population pharmacodynamic analyses have yet been conducted in this patient group. Effective ACE inhibition can be assumed at the administered dose in children with heart failure. Population analyses suggest that children with heart failure may be more sensitive to enalaprilat than healthy adults."

Journal • PK/PD data • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Heart Failure • Pediatrics

Population Pharmacokinetic Analysis of Enalapril and Enalaprilat in Newly Treated Children with Heart Failure: Implications for Safe Dosing of Enalapril (LENA Studies). (PubMed, Clin Pharmacokinet) - P2/3 | "The results of the PopPK analysis and simulations indicated that, in addition to the currently considered parameters of weight and renal function, the parameters of age and severity of heart failure should also be considered when dosing enalapril in children with heart failure."

Journal • PK/PD data • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Heart Failure

Acceptability and Palatability of Novel Orodispersible Minitablets of Enalapril in Children up to the Age of 6 with Heart Failure. (PubMed, J Clin Med) - " Enalapril ODMTs are widely accepted and well-tolerated among young children, including neonates, with heart failure. These findings suggest that ODMTs are a suitable and effective method for administering pediatric medicinal products."

Journal • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Heart Failure • Pediatrics

Safe Initial Dosing of Innovative Enalapril Orodispersible Minitablets in Newly Treated Newborns, Infants and Young Children with Heart Failure – Results of a Population Pharmacokinetic Analysis of the LENA Trials (AHA 2024) - "The newly detected covariate Ross score provides the scientific basis for considering the severity of heart failure at the initial dose. The initial dose should be lowered depending on the level of the Ross score to avoid high peak concentrations and a potential drop in blood pressure."

Clinical • PK/PD data • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Heart Failure • Hypotension

Clinical and Hemodynamic Outcomes with Enalapril Orodispersible Minitablets in Young Children with Heart Failure Due to Congenital Heart Disease. (PubMed, J Clin Med) - "During 8 weeks follow-up, there were no difference in the z-scores for the systolic blood pressure (p = 0.071) or heart rate (p = 0.146). Pediatric patients treated with ODMTs of enalapril for 8 weeks had favorable improvements in LVD and HF symptoms."

Journal • Cardiovascular • Congestive Heart Failure • Heart Failure • Pediatrics

Enalapril and Enalaprilat Pharmacokinetics in Children with Heart Failure Due to Dilated Cardiomyopathy and Congestive Heart Failure after Administration of an Orodispersible Enalapril Minitablet (LENA-Studies). (PubMed, Pharmaceutics) - "The dosing schedule appeared to be tolerated well and did not result in any significant drug-related serious adverse events. The PK analysis and the lack of severe safety events supports the applied age-appropriate dosing schedule for the enalapril ODMTs."

Journal • PK/PD data • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Heart Failure • Pediatrics

Orodispersible minitablets of enalapril for use in children with heart failure (LENA): Rationale and protocol for a multicentre pharmacokinetic bridging study and follow-up safety study. (PubMed, Contemp Clin Trials Commun) - P2/3; "Results of the studies will be submitted for publication in a peer-reviewed journal. EudraCT 2015-002335-17, EudraCT 2015-002396-18, EudraCT 2015-002397-21."

Clinical • Journal • PK/PD data