Abstracts

Rationale: To assess the improvement in quality-of-life and depressive symptoms during long-term adjunctive therapy with eslicarbazepine acetate (ESL) in patients with refractory partial epilepsy. Methods: During an open-label extension of a phase 3 study (BIA-2093-303) with ESL, the Quality-of-Life in Epilepsy Inventory 31 (QOLIE-31) and Montgomery Asberg Depression Rating Scale (MADRS) were applied at the end of the treatment period (1 year or early discontinuation) and the results were compared with those at baseline. Most patients were treated with ESL 800 mg once-daily (range: 400-1500 mg). Results: When assessing the QOLIE-31 results in the intent-to-treat (ITT) population (n=154), significant improvements from baseline were found in overall quality-of-life (p<0.01), seizure worry (p<0.0001), emotional well-being (p<0.0001), energy-fatigue (p=0.0001), cognitive functioning (p<0.01), medication effects (p<0.001), social function (p<0.0001), and the overall score (p<0.0001) (Figure 1). In the per-protocol (PP) population (n=99), significant improvements were found in overall quality-of-life (p<0.001), seizure worry (p<0.0001), emotional well-being (p<0.0001), energy-fatigue (p<0.0001), cognitive functioning (p<0.01), medication effects (p<0.01), social function (p<0.0001), and overall score (p<0.0001). Regarding the MADRS results in the ITT population (n=166), statistically significant improvements were found in the total score (from 10.5 to 7.8; p<0.0001), apparent sadness (p<0.01), reduced sleep (p<0.05), reduced appetite (p<0.05), concentration difficulties (p=0.0001), lassitude (p<0.05), inability to feel (p<0.01), and pessimistic thoughts (p<0.001) (Figure 2). In the PP population (n=108), significant improvements were found in the total score (p<0.0001), apparent sadness (p<0.01), inner tension (p<0.05), reported sadness (p<0.01), concentration difficulties (p<0.001), lassitude (p<0.05), inability to feel (p<0.01), and pessimistic thoughts (p<0.001) Conclusions: Statistically and clinically significant improvement from baseline was found in quality-of-life, as assessed by QOLIE-31, and depressive mood, as assessed by MADRS, during long-term open-label adjunctive therapy with ESL in partial epilepsy. Supported by BIAL- Portela & Co, SA