Topiramate monotherapy for partial onset seizures

被引:136
作者
Sachdeo, RC
Reife, RA
Lim, P
Pledger, G
机构
[1] RW JOHNSON PHARMACEUT RES INST,SPRING HOUSE,PA 19477
[2] RW JOHNSON PHARMACEUT RES INST,RARITAN,NJ 08869
关键词
topiramate; antiepileptic drugs; partial onset seizures; generalized seizures; monotherapy;
D O I
10.1111/j.1528-1157.1997.tb01120.x
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
Purpose: Evaluation of topiramate (TPM) as monotherapy in patients with uncontrolled partial onset seizures. Methods: A total of 48 patients were evaluated in a double blind, parallel-group trial. During a 56-day baseline period, patients had at least eight partial onset seizures while being treated with one or two standard antiepileptic drugs (AEDs). After 1-2 weeks of open-label treatment with TPM 100 mg/day, patients were randomly assigned, in equal proportions, to receive double-blind therapy with TPM 100 or 1,000 mg/day in a 5-week conversion and an 11-week monotherapy period. The study endpoint was completion of 112 study days (success) or fulfillment of one or more exit criteria: doubling of average 28-day or highest 2-day baseline seizure rate, a generalized tonic-clonic seizure (GTCS) if none had occurred at baseline, or significant prolongation of generalized seizure duration. Results. Time until exit was longer (p = 0.002) and success frequency was higher (p = 0.005) with TPM 1,000 as compared with 100 mg/day. Seizure-rate reductions of greater than or equal to 50, greater than or equal to 75, or 100% were achieved by 46, 25, and 13% of the 1,000-mg/day group, respectively, as compared with 13, 8, and 0% of the 100-mg/day group, respectively. Most adverse events (AE) were mild or moderate in severity. Conclusions: Monotherapy with TPM 1,000 mg/day for partial onset seizures with or without secondarily generalized seizures was effective, with a favorable safety profile.
引用
收藏
页码:294 / 300
页数:7
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