BOSTON—Across a likely spectrum of syndromes with generalized seizures, the effect of adjunctive antiepileptic drug (AED) treatment on primary generalized tonic-clonic seizures appears similar between adults and children, according to a report presented at the 69th Annual Meeting of the American Academy of Neurology.
Douglas Nordli Jr, MD
The availability of new AEDs for pediatric patients has been delayed due to the challenges of conducting clinical trials in children. In response to this challenge, the feasibility of extrapolation of adjunctive efficacy results for partial-onset seizures has been previously shown by Pellock et al from adult to pediatric populations when the disease course and pharmacokinetics of drug effects are comparable between populations. In response to a request from the Pediatric Committee of the European Medicines Agency, Douglas Nordli Jr, MD, and colleagues explored the feasibility of extrapolating AED efficacy data from adults to pediatric patients with primary generalized tonic-clonic seizures. Dr. Nordli is the Chief of the Division of Pediatric Neurology and Codirector of the Neurosciences Institute at Children's Hospital Los Angeles.
Dr. Nordli and colleagues conducted literature searches in EMBASE, Medline, and the Cochrane Central Register of Controlled Trials for randomized, placebo-controlled clinical trials of adjunctive AED treatment for primary generalized tonic-clonic seizures in adults and children published from 1970 to 2015. Outcome data, expressed as median percent reduction in seizure frequency and greater than or equal to 50% responder rate, were extracted from eligible trials for adult and pediatric patients receiving adjunctive AEDs or placebo and used to determine the relative strength of baseline-subtracted efficacy measures.
Seven published trials of AED adjunctive therapy for primary generalized tonic-clonic seizures were eligible for quantitative analysis. Dr. Nordli and colleagues found that changes in efficacy measures were similar in adults and children with primary generalized tonic-clonic seizures and were not age-dependent. The 95% confidence intervals for the standardized mean difference in median percent reduction of seizure frequency and estimated risk ratios in greater than or equal to 50% responder rate were consistently in favor of the AED treatment and comparable between adult and pediatric groups.
Dr. Nordli's study was supported by Eisai.
Suggested Reading
Pellock JM, Carman WJ, Thyagarajan V, et al. Efficacy of antiepileptic drugs in adults predicts efficacy in children: a systematic review. Neurology. 2012;79(14):1482-1489.