Abstracts

RATIONALE: To compare adjunctive and monotherapy with lamotrigine (LAMICTAL?, LTG) or carbamazepine (TEGRETOL?, CBZ) in patients with uncontrolled epilepsy with a broad spectrum of seizure types. Final data from 143 US patients from an open label International trial are presented. METHODS: Patients 16 y/o or older with uncontrolled epilepsy on a stable dose of a single antiepileptic drug were randomized 2:1 to LTG or CBZ. The study consisted of 3 phases: Add-on (12 wk), Withdrawal (8 wk) and Monotherapy (8 wk). Endpoints included seizure frequency, adverse events (AEs), the Liverpool Quality of Life Seizure Severity Scale, and the AE Profile. RESULTS: Following conversion to monotherapy, seizure free rates were greater for LTG than CBZ (41% vs 30%) as well as for patients reporting ?75% seizure reduction (54% vs 47%). Equal percentages of patients (56%) in both groups were successfully withdrawn to monotherapy, however LTG patients remained on study drug slightly longer than CBZ patients, (165 days vs 152 days). Mean monotherapy doses for LTG and CBZ were 381mg and 927mg respectively. AE rates were comparable (LTG=92% and CBZ=89%), however fewer LTG patients than CBZ patients had a drug related AE (62% vs 72%), and this lead to discontinuation of therapy in fewer LTG patients than CBZ patients (14% vs 26%). Improvements were noted for LTG and CBZ as measured by the Liverpool Quality of Life Seizure Severity Scale (p?0.001). CONCLUSIONS: When considering a monotherapy agent in patients with uncontrolled epilepsy experiencing a broad spectrum of seizure types, these data suggest that LTG is better tolerated and more efficacious than CBZ.