Empagliflozin in paediatric heart failure: model-based optimisation of a pharmacokinetic bridging study

Repurposing of drugs for paediatric rare diseases is fraught with challenges. Our results indicate that a weight-banded regimen with commercially available tablets of 10 mg empagliflozin can be used in a prospective protocol including paediatric patients with body weight ≥15 kg. In addition, this study illustrates the importance of optimising evidence generation in paediatric clinical trials through model-based approaches, ensuring that available knowledge is used to maximise the information content and reduce patient burden.