medwireNews: Pediatric neurologists can reasonably assume that an antiepileptic drug that is effective in adults will have similar benefits in children with partial-onset seizures, say the authors of a systematic review.
"The finding should provide some reassurance and support to all pediatric neurologists who, for decades, have had no other choice but to prescribe antiepileptic drugs off-label in order to do what they thought was best for their patients," write Blaise Bourgeois (Children's Hospital Boston, Massachusetts, USA) and Howard Goodkin (University of Virginia Health Systems, Charlottesville, USA) in an editorial accompanying the review.
But they add: "It is imperative to keep in mind that safety, adverse effects, and pharmacokinetics in children cannot be predicted from studies in adults."
Antiepileptic drugs are rarely formally tested in children. John Pellock (Virginia Commonwealth University, Richmond, USA) and team identified 30 randomized controlled trials of antiepileptic drugs in patients with partial-onset seizures, of which just six were in children aged 2 to 18 years. They also searched for trials in children with primary generalized tonic-clonic seizures, but found only one that met their inclusion criteria.
Overall, adults experienced between a 7.0% and 58.6% reduction in the frequency of seizures, and children had a 10.5% to 31.2% reduction. The size of treatment benefit in children was within the ranges reported for adults for lamotrigine, levetiracetam, oxcarbazepine, topiramate, and also for gabapentin, the team reports in Neurology.
Bourgeois and Goodkin observe that the data are "less convincing" for gabapentin than for the other drugs, but say that this could be due to nonequivalent dosing. There were no trials of eslicarbazepine or lacosamide in children available for analysis.
The editorialists note that no drug that showed benefits in adults with partial-onset seizures failed to benefit children in at least one trial. "Given this finding, the authors' conclusion is justified, as these trials were all superiority/inferiority studies with significant differences."
However, they caution that because of differences in trial design and drug doses, "one cannot exclude the possibility that any of the antiepileptic drugs could be less effective in children than in adults at any dose."
The study also cannot shed light on the efficacy of antiepileptic drugs in benign focal epilepsies of childhood, say Bourgeois and Goodkin. They conclude: "There is a continued need for randomized controlled studies in children to be performed either prior to initial marketing or soon thereafter."
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