Abstracts

Rationale: Eslicarbazepine acetate (ESL) is a novel voltage-gated sodium channel blocker currently in development for the treatment of partial-onset seizures in adults. To gain an understanding of the nature and risk of changes in weight, glucose, and lipids when using ESL as an adjunctive antiepileptic drug (AED), these metabolic parameters were analyzed in subjects taking ESL compared with placebo as adjunct therapy to 1-3 concomitant AEDs in the pooled data of 3 Phase III studies. Methods: We studied all (N=1049) subjects who received at least 1 dose of study medication (400 mg, 800 mg, or 1200 mg of ESL or placebo). The incidence of sponsor-defined potentially clinically significant (PCS) and mean change from baseline values were analyzed by treatment group. PCS values were defined as an increase or decrease of 7% for weight; ?40 mg/dL or ?175 mg/dL for glucose; ?3x ULN for AST and ALT; and >300 mg/dL for TC; >160 mg/dL for LDL-C; <30 mg/dL for HDL-C; >2.5 x ULN for TRIG. TEAEs were defined as an event that occurred on or after the date of first dose, or the date of randomization if the date of the first dose was missing. Results: PCS incidences for each treatment group are summarized in Table 1 below. Mean changes from baseline to end of the double-blind period for each treatment group are shown in Table 2. The incidence of TC related AEs in the ESL treatment groups was similar to placebo. Conclusions: No consistent pattern of PCS values was observed for weight, glucose, AST, ALT, TC, LDL-C, HDL-C, or TRIG across the treatment groups. No clinically significant mean changes from baseline were observed. The incidence of AEs related to these metabolic parameters was similar between the eslicarbazepine acetate and placebo treatment groups.