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Clobazam as Add-on Therapy in Children with Epileptic Encephalopathy

Published online by Cambridge University Press:  10 January 2017

Rosana Carvalho Silva
Affiliation:
Department of Neurology, State University of Campinas (Unicamp), São Paulo, Brazil
Maria Augusta Montenegro
Affiliation:
Department of Neurology, State University of Campinas (Unicamp), São Paulo, Brazil
Carlos A.M. Guerreiro
Affiliation:
Department of Neurology, State University of Campinas (Unicamp), São Paulo, Brazil
Marilisa M. Guerreiro*
Affiliation:
Department of Neurology, State University of Campinas (Unicamp), São Paulo, Brazil
*
Department of Neurology, FCM/Unicamp, P.O Box 6111, 13083-970, Campinas, SP, Brazil
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Abstract:

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Rationale:

Clobazam has been used successfully in adults and children with partial epilepsy. The purpose of this study was to evaluate the safety and efficacy of clobazam as add-on therapy in children with epileptic encephalopathy.

Methods:

This was a retrospective study conducted at the pediatric epilepsy clinic of our university hospital. Children less than 18-years of age with epileptic encephalopathy were included in the study. Clobazam was introduced as add-on therapy, starting with 5 mg/Kg/day and increased in minimally effective doses, up to the maximum tolerated dose. Data were obtained from clinical files and follow-up visits.

Results:

Ninety-seven patients were included in the study (39 girls), aged between 1 and 17-years-old (mean = 9.9). Twenty-six patients had Lennox-Gastaut syndrome, seven had myoclonic astatic epilepsy, nine had West syndrome and, in 57 patients, the type of epileptic encephalopathy could not be determined. Clobazam dosage ranged from 5 to 60 mg/day (mean = 37.5 mg/day). Forty (41%) patients presented with adverse events, most of which were mild and transitory, and clobazam needed to be withdrawn in only 11 patients. Nine (9.2%) patients were seizure-free after clobazam adjunctive therapy. In 11 (11.3%) patients seizure improvement was >75%, in 16 (16.5%) it was >50%, in 17 (17.5%) improvement was <50% and in 44 (45.5%) there was no change in seizure frequency. Three patients were lost to follow-up. In 85% of the patients with seizure improvement, the results lasted for more than one year.

Conclusion:

Clobazam is safe and effective in the treatment of epileptic encephalopathies of childhood.

Résumé:

RÉSUMÉ:Justification:

Le clobazam a été utilisé avec succès chez les adultes et les enfantsatteints d’épilepsie partielle. L’objectif de cetteétude était d’évaluer la sécurité et l’efficacité du clobazamcommetraitement d’appoint chez les enfantsatteints d’épilepsie partielle.

Méthodes:

Il s’agit d’une étude rétrospective chez des enfants de moins de 18 ansatteints d’encéphalopathie épileptique, qui fréquentent la clinique d’épilepsie pédiatrique de notre hôpital universitaire. Le clobazamétait prescritcommetraitement d’appoint avec une dose de départ de 5 mg/Kg/jour. La posologieétait augmentée progressivement d’une dose efficaceminimalejusqu’à la dose maximaletolérée. Les données ontété tirées des dossiers cliniques et des visites de suivi.

Résultats:

Quatre-vingt-dix-sept patients ontété inclusdans l’étude (39 filles et 58 garçons), âgés de 1 à 17 ans (moyenne de 9,9 ans). Vingt-six patients étaient porteurs du syndrome de Lennox-Gastaut, septétaient atteints d’épilepsie astatiquemyoclonique, neuf du syndrome de West et le type d’encéphalopathie épileptique était indéterminé chez 57 patients. La dose de clobazamvariait de 5 à 60 mg/jour (moyenne de 37,5 mg/jour). On a observé des incidents thérapeutiques chez quarante patients (41%) et la plupartontété légers et transitoires. On a dû cesser l’administration du clobazam chez 11 patients seulement. Neuf patients (9,2%) n’avaient plus de crises après l’introduction du clobazamcommetraitement d’appoint. Chez 11 patients (11,3%) l’amélioration était > 75%, > 50% chez 16 (16,5%), < 50% chez 17 (17,5%) et aucunchangementdans la fréquence des crises n’a été observé chez 44 patients (45,5%). Troispatientsontinterrompu le suivi. Chez 85% des patients qui onteuune amélioration des crises, les résultats ont persisté plus d’un an.

Conclusion:

Le clobazamest sûr et efficacedans le traitement des encéphalopathies épileptiques de l’enfance.

Type
Original Articles
Copyright
Copyright © The Canadian Journal of Neurological 2006

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