Clobazam as add-on therapy in children with epileptic encephalopathy.
BACKGROUND
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 Forty (41%) patients presented with adverse events, most of which were mild and transitory, and clobazam needed to be withdrawn in only 11 patients.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.


CONCLUSIONS
Clobazam is safe and effective in the treatment of epileptic encephalopathies of childhood.
Silva
Rosana Carvalho
RC
Department of Neurology, State University of Campinas, São Paulo, Brazil.
Montenegro
Maria Augusta
MA
Guerreiro
Carlos A M
CA
Guerreiro
Marilisa M
MM
D000293:Adolescent; D000927:Anticonvulsants / Q000008:administration & dosage* / Q000009:adverse effects; D001569:Benzodiazepines / Q000008:administration & dosage* / Q000009:adverse effects; D001921:Brain / Q000002:abnormalities* / Q000187:drug effects* / Q000503:physiopathology; D002648:Child; D002675:Child, Preschool; D000078306:Clobazam; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004351:Drug Resistance / Q000502:physiology; D004357:Drug Synergism; D004569:Electroencephalography / Q000187:drug effects; D004831:Epilepsies, Myoclonic / Q000188:drug therapy / Q000503:physiopathology / Q000517:prevention & control; D004827:Epilepsy / Q000188:drug therapy* / Q000503:physiopathology / Q000517:prevention & control; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D009421:Nervous System Malformations / Q000150:complications*; D010352:Patient Dropouts / Q000706:statistics & numerical data; D012189:Retrospective Studies; D013036:Spasms, Infantile / Q000188:drug therapy / Q000503:physiopathology / Q000517:prevention & control; D016896:Treatment Outcome
D000927:Anticonvulsants; D001569:Benzodiazepines; D000078306:Clobazam