Abstracts

Rationale: An evaluation of how epilepsy affects a patient’s daily life is an important component of treatment decision-making. This analysis examined changes in health-related quality-of-life (HRQOL) among patients who experienced a clinical response after conversion to eslicarbazepine acetate (ESL) monotherapy.Methods: In two historical-controlled double-blind clinical trials (045 and 046), patients not controlled by current anti-epileptic drugs were randomly assigned to be converted to either 1200 mg QD or 1600 mg QD of ESL monotherapy over an 8-week period. Patients from both trials with ≥50% seizure frequency reduction from baseline to week 18 (end of 10-week ESL monotherapy period) were pooled for analysis. Mean changes (Δ) from baseline to week 18 in Quality of Life in Epilepsy-31 (QOLIE‑31) Total Score and subscale scores were compared using paired two-sided t-tests and to established minimal clinically-important differences (MCIDs).Results: Of the 134 patients who experienced a clinical response (40.4% of efficacy population), 107 (79.9%) had QOLIE-31 results available at both baseline and week 18. Total Score significantly improved (mean Δ=7.71, p<0.001) and was greater than the MCID (see figure); overall 56 patients (52.3%) had an improvement greater than the MCID. Additionally, all seven subscales significantly improved, five with mean Δ greater than the MCID: Seizure Worry (mean Δ=11.51, p<0.001), Cognitive Functioning (mean Δ=6.58, p<0.001), Medication Effects (mean Δ=12.38, p<0.001), Social Functioning (mean Δ=10.07, p<0.001), and Overall QOL (mean Δ=9.49, p<0.001). Overall, 11 (10.3%) of 107 patients experienced improvements greater than the MCID in Total Score and all seven subscales.Conclusions: In this analysis, patients with clinical response to ESL monotherapy also experienced statistically-significant and clinically-meaningful improvements in HRQOL.