Long-Term Quality of Life in Patients With Focal Seizures Treated With ESL: Pooled Analysis From 3 Phase III Open-Label Extension Studies (P11-1.009)

Abstract

<h3>Objective:</h3> Data from a post-hoc pooled analysis was used to describe changes in health-related quality of life (HRQOL) measures during treatment with eslicarbazepine acetate (ESL). <h3>Background:</h3> ESL is approved for the treatment of focal seizures. HRQOL may be improved by controlling seizures. <h3>Design/Methods:</h3> Data from 3 randomized clinical trials were pooled for this post-hoc analysis. After completing the double-blind portion, patients were eligible to enter the 1-year open-label extension (OLE), which began immediately after the maintenance period or after a 4-week taper period. ESL was initiated at 400 or 800 mg/day, titrated in 400mg increments to a maximum 1600 mg/day. HRQOL was measured at baseline and last assessment using the Quality of Life in Epilepsy Inventory (QOLIE-31). Mean QOLIE-31 scores and mean change in scores were analyzed (t-test). The percentage of patients with QOLIE-31 score improvements beyond the minimal important change (MIC) threshold (baseline to final assessment) is described. <h3>Results:</h3> Of 959 patients who entered, 677 patients completed the OLE. Mean change in seizure worry, overall quality of life, emotional well-being, medication side effects, social functioning, and total score were significantly improved for patients who entered the OLE. Mean change ranged from 0.76 (energy/fatigue) to 4.93 (seizure worry). Mean change in all QOLIE-31 categories was significantly improved in patients who completed the OLE, ranging from 2.16 (cognitive functioning) to 6.58 (seizure worry). The highest percentage of patients reached the MIC threshold in social functioning (46.8%–48.9%), followed by medication effects (43.8%–47.4%), and seizure worry (42.1%–45.3%) in patients who entered the OLE and who completed the OLE, respectively. The lowest number of subjects met MIC criteria for energy/fatigue in both patient groups. <h3>Conclusions:</h3> Treatment with therapeutic doses of adjunctive ESL in patients with focal seizures for a period of up to one year was associated with improvements in HRQOL. <b>Disclosure:</b> Dr. Cantu has received personal compensation for serving as an employee of Sunovion Pharmaceuticals Inc.. Dr. Krishnaiengar has nothing to disclose. Dr. Thomases has received personal compensation for serving as an employee of Sunovion Pharmaceuticals. Darshan Mehta has received personal compensation for serving as an employee of Sunovion Pharmaceuticals Inc. . Ms. Hall has received personal compensation for serving as an employee of Sunovion Pharmaceuticals Inc.. Ian Zhang has received personal compensation for serving as an employee of Sunovion Pharmaceuticals Inc.. Helena Gama has received personal compensation for serving as an employee of Bial-Portela &amp; Cª S.A.. Ana Pereira has received personal compensation for serving as an employee of BIAL, Portela &amp; Cª S.A.. Todd Grinnell, PhD has received personal compensation for serving as an employee of Sunovion Pharmaceuticals Inc..