Clobazam: effect on frequency of seizures and safety profile in different subgroups of children with epilepsy.
BACKGROUND
Clobazam has been used in clinical practice as an adjunctive treatment for diverse seizure types and epilepsy syndromes. We evaluated the efficacy and safety of clobazam in a large sample of patients with refractory epilepsy at a tertiary pediatric center.


METHODS
We retrospectively reviewed patients treated with clobazam between January 2001 and July 2013 who had a follow-up visit at least one month after starting clobazam. Response was defined as ≥50% reduction in seizure frequency compared with baseline seizure frequency during the 3 months before the introduction of clobazam. We examined the relationship between dose range and response rate.


RESULTS
Four-hundred twenty-five patients were prescribed clobazam, of whom 300 (median age 9.1 years, interquartile range 4.7-13.3 years) had follow-up data greater than 1 month. Median follow-up was 5 months (interquartile range 3-11 months). Response to treatment with clobazam was observed in 203 of 300 (67.7%) patients, of whom 84 (28%) became seizure-free. The median starting dose was 0.2 (interquartile range 0.13-0.33) mg/kg/day with a target dose of 0.48 (0.26-0.80) mg/kg/day. Twenty-seven (9%) patients discontinued clobazam, 16 (59.3%) because adverse effects, 10 (37%) because of a lack of efficacy, and one (3.7%) because of a combination of adverse effects and lack of efficacy. The most common adverse effects were tiredness in 44 of 300 (14.6%) and mood or behavioral changes in 23 (7.7%).


CONCLUSIONS
Clobazam is a well-tolerated antiepileptic drug with good response rates in pediatric patients with refractory epilepsy.
Epilepsy and Clinical Neurophysiology, Boston Children's Hospital, Boston, Massachusetts. Electronic address: jacquelyn.klehm@childrens.harvard.edu.
Jacquelyn
J
Klehm
Epilepsy and Clinical Neurophysiology, Boston Children's Hospital, Boston, Massachusetts; Psychiatry Department, Clinics Hospital of University of Sao Paulo, Sao Paulo, Sao Paulo, Brazil.
Sigride
S
Thome-Souza
Epilepsy and Clinical Neurophysiology, Boston Children's Hospital, Boston, Massachusetts; Department of Child Neurology, Hospital Sant Joan de Déu, University of Barcelona, Barcelona, Catalonia, Spain.
Iván
I
Sánchez Fernández
Epilepsy and Clinical Neurophysiology, Boston Children's Hospital, Boston, Massachusetts.
Ann M
AM
Bergin
Epilepsy and Clinical Neurophysiology, Boston Children's Hospital, Boston, Massachusetts.
Jeffrey
J
Bolton
Epilepsy and Clinical Neurophysiology, Boston Children's Hospital, Boston, Massachusetts.
Chellamani
C
Harini
Epilepsy and Clinical Neurophysiology, Boston Children's Hospital, Boston, Massachusetts.
Navah E
NE
Kadish
Epilepsy and Clinical Neurophysiology, Boston Children's Hospital, Boston, Massachusetts.
Mark
M
Libenson
Epilepsy and Clinical Neurophysiology, Boston Children's Hospital, Boston, Massachusetts.
Jurriaan
J
Peters
Epilepsy and Clinical Neurophysiology, Boston Children's Hospital, Boston, Massachusetts.
Annapurna
A
Poduri
Epilepsy and Clinical Neurophysiology, Boston Children's Hospital, Boston, Massachusetts.
Alexander
A
Rotenberg
Epilepsy and Clinical Neurophysiology, Boston Children's Hospital, Boston, Massachusetts.
Masanori
M
Takeoka
Epilepsy and Clinical Neurophysiology, Boston Children's Hospital, Boston, Massachusetts.
Blaise
B
Bourgeois
Epilepsy and Clinical Neurophysiology, Boston Children's Hospital, Boston, Massachusetts.
Tobias
T
Loddenkemper
D000293:Adolescent; D000927:Anticonvulsants / Q000627:therapeutic use*; D001569:Benzodiazepines / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D000078306:Clobazam; D004305:Dose-Response Relationship, Drug; D004827:Epilepsy / Q000145:classification / Q000188:drug therapy* / Q000503:physiopathology*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D012189:Retrospective Studies; D012640:Seizures / Q000188:drug therapy*; D018709:Statistics, Nonparametric; D013997:Time Factors; D016896:Treatment Outcome
D000927:Anticonvulsants; D001569:Benzodiazepines; D000078306:Clobazam
efficacy; epilepsy; pediatric; refractory epilepsy; seizure