Jacquelyn Klehm1, Sigride Thome-Souza2, Iván Sánchez Fernández3, Ann M Bergin4, Jeffrey Bolton4, Chellamani Harini4, Navah E Kadish4, Mark Libenson4, Jurriaan Peters4, Annapurna Poduri4, Alexander Rotenberg4, Masanori Takeoka4, Blaise Bourgeois4, Tobias Loddenkemper4. 1. Epilepsy and Clinical Neurophysiology, Boston Children's Hospital, Boston, Massachusetts. Electronic address: jacquelyn.klehm@childrens.harvard.edu. 2. Epilepsy and Clinical Neurophysiology, Boston Children's Hospital, Boston, Massachusetts; Psychiatry Department, Clinics Hospital of University of Sao Paulo, Sao Paulo, Sao Paulo, Brazil. 3. 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. 4. Epilepsy and Clinical Neurophysiology, Boston Children's Hospital, Boston, Massachusetts.
Abstract
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.
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.
Authors: Martin J Brodie; Frank Besag; Alan B Ettinger; Marco Mula; Gabriella Gobbi; Stefano Comai; Albert P Aldenkamp; Bernhard J Steinhoff Journal: Pharmacol Rev Date: 2016-07 Impact factor: 25.468