Efficacy data from adult clinical trials of antiepileptic drugs (AEDs) can be used to determine the efficacy of these agents in children according to a recent analysis published in Epilepsia.
- The need for efficacious AEDs for children is urgent given the fact that epileptic seizures are the most common serious neurological problem in this population.
- The pathophysiology of focal epilepsy in children is similar to that found in adults, based on anatomical and neurophysiological evidence.
- The structural and physiological features that underlie seizures in adults and children aged 2 years and older are similar and justify extrapolation of efficacy data from adults to children.
- However, these similarities do not justify extrapolating pharmacokinetic, tolerability, and safety data from adults to children.
- Similarly, published data do not allow one to assume that long-term follow-up in children on AEDs will be the same as follow-up results in adults.
Pellock JM, Arzimanoglou A, D’Cruz O, Holmes GL, Nordli D, Shinnar S; Pediatric Epilepsy Academic Consortium for Extrapolation. Extrapolating evidence of antiepileptic drug efficacy in adults to children ≥2 years of age with focal seizures: The case for disease similarity. Epilepsia. 2017;58(10):1686-1696.