Topiramate vs. Investigator Choice of Carbamazepine of Valproate as Monotherapy in Newly Diagnosed Epilepsy
Abstract number :
2.019
Submission category :
Year :
2000
Submission ID :
1246
Source :
www.aesnet.org
Presentation date :
12/2/2000 12:00:00 AM
Published date :
Dec 1, 2000, 06:00 AM
Authors :
Michael D Privitera, Martin J Brodie, Walter Neto, Steven Wang, Univ of Cincinnati Medical Ctr, Cincinnati, OH; Western Infirmary, Glasgow, United Kingdom; R W Johnson Pharm Research Institute, Raritan, NJ.
RATIONALE: In two double-blind dose-response studies, topiramate (TPM) was effective as monotherapy in chronic refractory partial-onset seizures and in recently diagnosed localization-related epilepsy. This double-blind study compared TPM with clinicians choices for initial monotherapy in newly diagnosed epilepsy -- carbamazepine (CBZ) and valproate (VPA). METHODS: In patients with newly diagnosed epilepsy (diagnosis ?3 mos before entry; ?1 unprovoked seizure) and no prior antiepileptic drug (AED) use or only 1 AED for ?6 wks, investigators selected CBZ or VPA as their choice of therapy based on the patient?s seizure type(s) and profile. Patients were then assigned to either CBZ/TPM- or VPA/TPM-treatment arms and randomized to receive 100 mg/day TPM, 200 mg/day TPM, or investigator?s AED choice at dosages effective for newly diagnosed epilepsy (600 mg/day CBZ or 1250 mg/day VPA). Any baseline AED was withdrawn as study medication was titrated. Patients continued in the study until 6 mos after the last patient was randomized or until patient or investigator decided to discontinue or change study medication (adjust dosage regimen or add another AED) due to inadequate seizure control or adverse events. RESULTS: 623 patients (53% men) aged 6-84 yrs (mean, 34 yrs) entered the trial and were assigned to the CBZ/TPM-treatment arm (N=395) or the VPA/TPM-treatment arm (N=228). At study entry, median epilepsy duration was 1 month and median time since epilepsy diagnosis was 5 months. Overall, 52% in the CBZ/TPM-treatment arm and 49% in the VPA/TPM-treatment arm completed the trial without exiting. The most common reasons for exit were adverse events (21% CBZ/TPM arm; 23% VPA/TPM arm), inadequate seizure control (10% CBZ/TPM arm; 7% VPA/TPM arm) and patient choice (7% CBZ/TPM arm; 12% VPA/TPM arm). CONCLUSIONS: This study demonstrates that TPM is useful as first-line therapy in patients with newly diagnosed epilepsy. Final results with detailed comparisons for TPM vs CBZ and TPM vs VPA will be presented. Study supported by the R.W. Johnson Pharmaceutical Research Institute.