A pharmacokinetic study and correlation with clinical response of rufinamide in infants with epileptic encephalopathies

Giancarlo La Marca, Anna Rosati, Melania Falchi, Sabrina Malvagia, Maria Luisa Della Bona, Simona Pellacani, Renzo Guerrini

Research output: Contribution to journalArticle

Abstract

Aim: To evaluate the relationship between the pharmacokinetic (PK) parameters and therapeutic and adverse effects of rufinamide (RUF) in children with epileptic encephalopathies (EE) aged 50% decrease of seizures. Tolerability was evaluated by analysis of a parental report of adverse effects, a clinical examination and laboratory tests. Results: Maximum plasma concentration (47.40 ± 35.36 mg/l), average plasma concentration (39.94 ± 24.53 mg/l) and half-life (13.66 ± 4.43 h) were extremely variable and considerably higher than those reported in older children treated with the same dose regimen. At the last evaluation, 9 patients (60%) were responders. Conclusion: RUF is efficacious and is well tolerated in children with EE. Nonetheless, a correlation between dose, serum concentration and efficacy could not be demonstrated. The variability in measured concentrations may be related to polytherapy that is necessary for controlling seizures in this very severe form of epilepsy, in which the off-label use of RUF is justified.

Original languageEnglish
Pages (from-to)275-280
Number of pages6
JournalPharmacology
Volume91
Issue number5-6
DOIs
Publication statusPublished - Jul 2013

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Keywords

  • Epileptic encephalopathy
  • Pharmacokinetics
  • Rufinamide

ASJC Scopus subject areas

  • Pharmacology

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