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

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.

journal_name

Epilepsia

journal_title

Epilepsia

authors

Sugai K

doi

10.1111/j.0013-9580.2004.458005.x

subject

Has Abstract

pub_date

2004-01-01 00:00:00

pages

20-5

eissn

0013-9580

issn

1528-1167

pii

EPI458005

journal_volume

45 Suppl 8

pub_type

杂志文章

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