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      Efficacy and tolerability of adjunctive perampanel treatment in children under 12 years of age with refractory epilepsy

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          Abstract

          Purpose

          There is limited data on the use of perampanel in children under 12 years of age. We evaluated the efficacy and tolerability of adjunctive perampanel treatment in children under 12 years of age with refractory epilepsy.

          Methods

          This retrospective observational study was performed in Kyungpook National University Hospital from July 2016 to March 2018. A responder was defined as a patient with ≥50% reduction in monthly seizure frequency compared with the baseline. Adverse events and discontinuation data were obtained to evaluate tolerability.

          Results

          Twenty-two patients (8 males, 14 females) aged 3.1–11.4 years (mean, 8.0±2.5 years) were included in this study. After an average of 9.2 months (range, 0.5–19 months) of follow-up, 15 patients (68%) showed a reduction in seizure frequency, including 5 patients (23%) with seizure freedom. The age at epilepsy onset was significantly lower ( P=0.048), and the duration of epilepsy was significantly longer ( P=0.019) in responders than in nonresponders. Nine patients (41%) experienced adverse events, including somnolence (23%), respiratory depression (9%), violence (4.5%), and seizure aggravation (4.5%). The most serious adverse event was respiratory depression, which required mechanical ventilation in 2 patients (9%). Eight patients (36%) discontinued perampanel due to lack of efficacy or adverse events. Three out of 4 patients (75%) who discontinued perampanel due to adverse events had an underlying medical condition.

          Conclusion

          Perampanel offers a treatment option for refractory epilepsy in children. Adjunctive treatment with perampanel requires special consideration in those with underlying medical conditions to prevent serious adverse events.

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          Most cited references12

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          Concentration-effect relationships with perampanel in patients with pharmacoresistant partial-onset seizures.

          Although there is a general paucity of published pharmacokinetic (PK) data for new antiepileptic drugs (AEDs), PK analyses of pooled data from clinical studies of perampanel have recently been presented. We present PK/pharmacodynamic (PD) analyses of pooled data from phase III studies of perampanel describing efficacy and safety as a function of exposure, in order to determine whether a predictable concentration-effect relationship exists for perampanel efficacy and/or adverse events (AEs). The effects of concomitant enzyme-inducing AEDs (EIAEDs) and non-enzyme-inducing AEDs on the exposure, efficacy, and safety of perampanel are also considered.
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            Effectiveness and tolerability of perampanel in children and adolescents with refractory epilepsies: first experiences.

            This article aims to report the first clinical experiences concerning effectiveness and tolerability of perampanel (PER) in a pediatric population with refractory epilepsies.
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              Predictors and course of medically intractable epilepsy in young children presenting before 36 months of age: a retrospective, population-based study.

              To determine the prevalence and identify predictors of medical intractability in children presenting with epilepsy before 36 months of age, and to assess the effect of medical intractability on long-term mortality and intellectual function.
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                Author and article information

                Journal
                Korean J Pediatr
                Korean J Pediatr
                KJP
                Korean Journal of Pediatrics
                Korean Pediatric Society
                1738-1061
                2092-7258
                July 2019
                26 December 2018
                : 62
                : 7
                : 269-273
                Affiliations
                [1 ]Department of Pediatrics, School of Medicine, Kyungpook National University, Daegu , Korea
                [2 ]Department of Pediatrics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
                Author notes
                Corresponding author: Su-Kyeong Hwang, MD, PhD Department of Pediatrics, School of Medicine, Kyungpook National University, Hogook-Ro 807, Book-Gu, Daegu 41404, Korea Tel: +82-53-200-5704 Fax: +82-53-425-6683 E-mail: skhwang@ 123456knu.ac.kr
                Author information
                http://orcid.org/0000-0001-8294-7094
                Article
                kjp-2018-06863
                10.3345/kjp.2018.06863
                6642925
                30590000
                591f5256-9230-4efc-9e71-b308c2c71a35
                Copyright © 2019 by The Korean Pediatric Society

                This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 14 August 2018
                : 21 December 2018
                : 26 December 2018
                Categories
                Original Article
                Neurology

                Pediatrics
                perampanel,child,efficacy,tolerability,adverse events
                Pediatrics
                perampanel, child, efficacy, tolerability, adverse events

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