Should Adult AED Studies Determine Pediatric Usage?

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.

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.

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.