Abstracts

Rationale: Lacosamide is a new AED for adjunctive treatment of partial-onset seizures in adults. For the first time, the effects of long-term lacosamide treatment on patients self-reported seizure severity, health-related quality of life (HRQoL), and health status are reported. Methods: In the phase 3 open-label extension trial SP756 (NCT00522275), the Seizure Severity Questionnaire (SSQ; Cramer, 2002), Quality of Life In Epilepsy scale (QOLIE-31; Cramer, 1998), and Patient Global Impression of Change (PGIC) were included as health-outcomes assessments. The SSQ, measuring seizure severity on a 7-point scale, and the QOLIE-31, an epilepsy-specific HRQoL assessment with a 100-point range, were completed at weeks 16 and 48, with subsequent assessments every 48 weeks. The PGIC, a 7-category scale assessing change in health state, was performed at weeks 16 and 48. SSQ and QOLIE-31 scores at week 48 were compared to baseline scores in the double-blind trial that lead into the open-label trial. Data were analyzed using t-tests for observed cases (scores at each visit for patients with data at that visit), as well as a last observation carried forward approach (LOCF). The percentage of patients with a clinically meaningful QOLIE-31 improvement, based upon thresholds previously defined by the authors using phase 3 lacosamide trial data, was described at week 48. The percentage of patients by PGIC category was also described. Results: At week 48 (LOCF, n=270), patients showed a significant mean improvement on all SSQ subscales, including cognitive, emotional and physical effects during and after seizures. Patients also showed an average improvement of -0.64 on the Overall SSQ score, a rating combining overall seizure severity and bother. Improvement on all QOLIE-31 subscales was shown with the exception of Medication Effects (-1.85, NS). Significant improvements were found for Seizure Worry ( 9.00), Quality of Life ( 3.86), Emotional Well-Being ( 2.38), Social Functioning ( 3.43), and the Total score ( 2.89). On average, QOLIE-31 scores showed additional improvement after the first year. For all QOLIE-31 subscales, more than 35% of patients showed clinically meaningful improvement at week 48. The largest percentages of improved patients were found for the subscales of Seizure Worry (49.2%) and Social Functioning (50.8%). On the PGIC, 79.5% of patients reported overall improvement at week 16 (n=283), with 53.0% of patients in the very much or much improved category. At week 48 (n=244), 79.1% of patients said to have improved overall, with 64.3% of patients in the very much or much improved category. Conclusions: After one year of lacosamide treatment, significant improvements in all aspects of seizure severity, as well as in most aspects of HRQoL were observed. About half of patients showed clinically meaningful improvement on seizure worry and social functioning, indicating the effectiveness of lacosamide for both seizures and health-related outcomes. Most patients reported their overall health state to be much or very much improved.