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From the University of Alabama at Birmingham (Dr. Gilliam); Pasqua Hospital (Dr. Veloso), Regina, SK, Canada; Ignatius Ziekenhuis Poli Neurologie (Dr. Bomhof), Breda, the Netherlands; Neurology Clinic of San Antonio (Dr. Gazda), TX; Arkansas Epilepsy Program (Dr. Biton), Little Rock; Bosch Medicentrum (Dr. Ter Bruggen), Hertogenbosch, the Netherlands; and Johnson & Johnson Pharmaceutical Research & Development (Drs. Neto, Pledger, and Wu, and C. Bailey), Raritan, NJ.
Address correspondence and reprint requests to Dr. Frank G. Gilliam, Washington University Adult Epilepsy Center, Campus Box 8111, 660 South Euclid Avenue, St. Louis, MO 63110-1093.
Objective: To evaluate topiramate as monotherapy in adults and children with recently diagnosed, localization-related epilepsy, comparing two dosages of topiramate in a multicenter, randomized, double-blind study.
Methods: Adults and children (
3 years of age) were eligible if the maximum interval since epilepsy diagnosis was 3 years and patients had one to six partial-onset seizures during a 3-month retrospective baseline. At study entry, patients (N = 252) were untreated or receiving one antiepileptic drug for less than 1 month. After randomization to 50 or 500 mg/d topiramate (25 or 200 mg/d if weight 
50 kg), patients remained in the study until 4 months after the last patient was randomized or until patients met seizure-related exit criteria (e.g., had two seizures). The primary efficacy outcome was a univariate analysis of time-to-exit, which was time to second seizure in 96% of patients.
Results: The time-to-exit (median, 422 days vs 293 days) favored the higher dose of topiramate, but this difference was not significant. When time-to-exit was analyzed with time-to-first-seizure as a covariate, the difference between dosage groups was significant (p = 0.01), reflecting the higher seizure-free rates (54% vs 39%, p = 0.02) and longer time-to-first-seizure (median 317 days vs 108 days; p = 0.06) in patients receiving 200 or 500 mg/d topiramate. Higher plasma concentration was associated with increased time-to-first seizure (p < 0.01). Dose-related adverse events included paresthesia, weight loss, diarrhea, and hypoesthesia.
Conclusions: Although the primary efficacy analysis was negative, time-to-exit analyses that included time-to-first-seizure as a covariate, between-group differences in seizure-free rates, and longer time-to-first-seizure with higher serum concentration provide evidence that topiramate is effective as monotherapy in patients with localization-related epilepsy.
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|
|
|
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|
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|
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