A DOUBLE-BLIND CONTROLLED CLINICAL-TRIAL OF OXCARBAZEPINE VERSUS PHENYTOIN IN ADULTS WITH PREVIOUSLY UNTREATED EPILEPSY

In the last 5 years oxcarbazepine (OXC) has been registered in many co untries for use as first-line and add-on treatment for partial seizure s with or without secondarily generalized seizures (PS) and generalize d tonic-clonic seizures without partial onset (GTCS). Its use as monot herapy in adults with newly diagnosed epilepsy was investigated in thi s double-blind, randomized, parallel-group comparison with phenytoin ( PHT). A total of 287 adult patients, with either PS or GTCS, were rand omized. After retrospective baseline assessment, patients were randomi zed to OXC or PI-IT in a 1:1 ratio. The double-blind treatment phase w as divided into two periods: a flexible titration period of 8 weeks, f ollowed by 48 weeks of maintenance treatment. In the efficacy analyses , no statistically significant differences were found between the trea tment groups. Seventy patients (59.3%) in the OXC group and 69 (58.0%) in the PI-IT group were seizure-free during the maintenance period. A total of 56 of the patients in the OXC group discontinued treatment p rematurely (five because of tolerability reasons) compared to 61 in th e PI-IT group (16 for tolerability reasons). The number of premature d iscontinuations due to adverse experiences showed a statistically sign ificant difference in favour of OXC. There was no statistically signif icant difference between the groups with respect to the total number o f premature discontinuations. This trial provides further support for the efficacy and safety of OXC as first-line treatment in adults with PS and GTCS. In addition, the results show that OXC has significant ad vantages over PHT in terms of tolerability. (C) 1997 Elsevier Science B.V.