Abstracts

RATIONALE: To compare adjunctive and monotherapy with lamotrigine (LAMICTAL?, LTG) or valproate (DEPAKOTE?, VPA)in patients with uncontrolled epilepsy with a broad spectrum of seizure types. Final data from 154 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 VPA. 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 VPA (32% vs 11%) as well as for patients reporting ?75% seizure reduction (41% vs 21%) and ?50% seizure reduction (53% vs 36%). More LTG patients than VPA patients were successfully withdrawn to monotherapy (50% vs 41%), and LTG patients remained on study drug slightly longer than VPA patients, (166 days vs 158 days). Mean monotherapy doses for LTG and VPA were 425mg and 1689mg respectively. AE rates were comparable (LTG=80% and VPA=83%), however fewer LTG patients than VPA patients had a drug related AE (53% vs 70%), and this lead to discontinuation of therapy in fewer LTG patients than VPA patients (13% vs 21%). Greater improvements were noted for LTG than VPA in all domains of the Liverpool Quality of Life Seizure Severity Scale (p?0.008) and the AE profile (p?0.03). 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 VPA.