Abstracts

Rationale: This study explored the relationship between seizure frequency reduction (SFR) and health related quality of life (HRQoL) among patients initiating eslicarbazepine acetate (ESL) monotherapy for the treatment of partial-onset seizures. Methods: A post-hoc analysis of pooled data from two 18-week randomized dose-blind clinical trials (093-045/093-046) of patients not controlled by their current anti-epileptic drug regimen, who initiated ESL monotherapy (1200 mg QD or 1600 mg QD), was conducted. Outcome measures included percent SFR categorized into 25-point increments and HRQoL measured using the Quality of Life in Epilepsy-31 (QOLIE-31) questionnaire. SFR of ≥50% and ≥75% were considered clinically meaningful. QOLIE-31 total score (TS) ranges from 0 to 100, with higher scores indicating better HRQoL and a difference of 5.19 published as the minimal clinically important difference (MCID) (Borghs S, de la Loge C, Cramer JA. Defining minimally important change in QOLIE 31 scores. Epilepsy Behav 2012;23:230-234). A generalized linear model was used to examine week 18 QOLIE-31 TS least square means (LSMs) at different percent SFR categories, after adjusting for baseline QOLIE-31 TS. Results: Among the 332 patients in the pooled efficacy population, 251(75.6%) had seizure frequency and QOLIE-31 TS data available at both baseline and week 18. At week 18, patients with ≥75% SFR (n=51) had a significantly higher QOLIE-31 TS LSM of 70.9 (95% CI: 67.9, 73.9) compared to those in lower SFR categories (range: 62.8–66.0; p < 0.05). The QOLIE-31 TS LSM differences between the ≥75% to 100% SFR category and the lower SFR categories ranged between 4.9 and 8.1 points, with four out of five of these differences exceeding the MCID (Table 1). Conclusions: These analyses of data from two ESL monotherapy trials of partial onset seizure patients demonstrated that ≥75% SFR was associated with significantly better HRQoL compared to patients with lower percent SFR. Most differences in HRQoL between the ≥75% SFR category and lower percent SFR categories were also clinically meaningful. Funding: Research funded by Sunovion Pharmaceuticals Inc.