Patients Treated with Eslicarbazepine Acetate Monotherapy Show Quality of Life Improvement (P2.028)

OBJECTIVE: To evaluate changes in health-related quality-of-life (HRQOL) among epilepsy patients who received eslicarbazepine acetate (ESL) monotherapy (1200 mg QD or 1600 mg QD). BACKGROUND: Patient quality of life is important in treatment decision-making. Information on HRQOL in patients with partial-onset seizures, not being controlled by anti-epileptic drugs, was collected in two randomized, historical-controlled, double-blind clinical trials of ESL monotherapy (093-045/093-046) using the Quality of Life in Epilepsy-31 (QOLIE-31). DESIGN/METHODS: This analysis examined changes from baseline to week 18 (end of monotherapy period) in QOLIE-31 Total Score and its seven subscales among two groups of patients pooled from the two trials: 1) those who converted to ESL monotherapy over an 8-week taper/conversion period and remained on monotherapy through week 18 (Completers; n=226, 68.1[percnt] of efficacy population), and 2) those who achieved a seizure frequency reduction ≥50[percnt] (Responders; n=134, 40.4[percnt] of efficacy population). Mean changes were tested for being significantly different than zero using paired two-sided t-tests and were also compared to established minimal clinically-important differences (MCIDs). RESULTS: The QOLIE-31 was completed at both baseline and week 18 by 211 (93.4[percnt]) of 226 Completers and 107 (79.9[percnt]) of 134 Responders. Among Completers and Responders, Total Score significantly improved and exceeded the MCID of 5.19 (mean change=6.72, p p p p <0.05). Lastly, six subscales among Completers and five subscales among Responders showed improvement above their MCIDs. CONCLUSIONS: In this pooled analysis, patients who converted to ESL monotherapy and/or achieved a seizure frequency reduction ≥50[percnt] experienced significant improvement in HRQOL, with many experiencing clinically-meaningful improvement. Disclosure: Dr. Velez has received personal compensation for activities with Sunovion as an employee. Dr. Bond has nothing to disclose. Dr. Anastassopoulos has received personal compensation for activities with Covance as an employee. Dr. Wang has received personal compensation for activities with Covance as an employee. Dr. Cheng has received personal compensation for activities with Sunovian Pharmaceuticals, Inc. Dr. Sousa has received personal compensation for activities with BIAL as an employee. Dr. Blum has received personal compensation for activities with Sunovion Pharmaceuticals Inc. as an employee. Dr. Cramer has received personal compensation for activities with Bial, Eisai Inc., Sepracor, UCB Pharma, and Sunovion as a consultant.