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Epilepsia. 2004;45 Suppl 8:20-5.

Clobazam as a new antiepileptic drug and clorazepate dipotassium as an alternative antiepileptic drug in Japan.

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1
Department of Child Neurology, National Center Hospital for Mental, Nervous and Muscular Disorders, National Center of Neurology and Psychiatry, Kodaira, Tokyo, Japan. sugaik@ncnpmusashi.gr.jp

Abstract

PURPOSE:

To confirm the efficacy and to clarify the problems of clobazam (CLB) as a new antiepileptic drug (AED) and clorazepate (CLP) as an alternative AED in Japan.

METHODS:

CLB and CLP were added on or replaced with conventional AEDs in 55 and 170 patients with refractory epilepsies, respectively. Short-term efficacy was studied after at least 2 months of CLB administration and at least 4 weeks of CLP administration. Long-term efficacy was examined in 31 cases with CLB for > or =6 months and in 86 cases with CLP for > or =6 months. CLB was initiated at 0.15-0.40 mg/kg and increased by 0.1-0.2 mg/kg every 1-2 weeks up to 0.28-1.25 mg/kg. CLP was started at 0.3-0.7 mg/kg and increased by 0.2-0.3 mg/kg every 1-2 weeks up to 2.5 mg/kg. Tolerance was examined in 42 cases with CLB for > or =3 months and 112 cases with CLP for > or =4 weeks.

RESULTS:

CLB was effective, defined as > or =50% reduction in seizure frequency, in 71% of the short-term subjects and 81% of the long-term subjects. Short-term efficacy was better in symptomatic localization-related epilepsies, but long-term efficacy did not differ according to seizure classification. Short-term efficacy was not different by seizure types or EEG findings. CLP was effective in 70% of the short-term subjects and 80% of the long-term subjects. CLP was more effective in patients with localization-related epilepsies or in patients with partial seizures or focal epileptiform discharges on EEG. Adverse effects developed in 47% of CLB cases and 31% of CLP cases, but the incidence was reduced by lower initial doses and slow dose titration. Tolerance occurred in 24% of CLB cases and 48% of CLP cases, half within 3-4 months after the initiation of CLB and half by 2 months after the start of CLP. Upon rechallenge, 70% of CLB-tolerant cases and 50% of CLP-tolerant cases responded to each drug again by increasing or maintaining the dosage.

CONCLUSIONS:

Excellent efficacy of CLB and excellent and prolonged efficacy of CLP for refractory epilepsies were confirmed. Frequent tolerance and adverse effects were major problems, but were manageable.

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