Abstracts

Rationale: AED therapy often provides a reduction in seizure frequency and/or seizure severity in exchange for a potential increase in the frequency and severity of adverse events. Thus, it is of particular importance to understand the potential impact of an AED on a patient's overall HRQL when evaluating whether to add an AED to a patient's existing regimen. Perampanel, a novel post-synaptic AMPA glutamate receptor antagonist, was evaluated in 3 double-blind, randomized, controlled phase III trials (304, 305, 306) in a population of POS patients not adequately controlled with 1 to 3 concomitant AEDs. The QOLIE-31-P was administered in all 3 trials to assess the impact of perampanel on HRQL. Methods: The QOLIE-31-P was administered in patients where a valid language translation was available. Eight QOLIE-31-P scale scores (Energy, Mood, Daily Activities, Cognition, Medication Effects, Seizure Worry, Overall QOL, and QOLIE-31-P Total Score) were calculated at baseline and end of treatment. Change from baseline scores were utilized to categorize patients as improved, stable, or declined per minimal clinically important difference (MCID) thresholds estimated from a similar population of POS patients (Epilepsy Behav 2012;23:230-234). The proportion of patients in each of these categories was compared between perampanel and standard of care (SOC) groups. The proportion of QOL responders (MCID improved or stable) was compared between treatment groups in patients with greater than or equal to 50% seizure reduction (50% seizure responders). Results: A total of 801 patients completed the QOLIE-31-P at baseline and end of treatment. The majority (73-90%) of patients experienced improvement or stabilization on all scale scores of the QOLIE-31-P. The distribution of improved, stable, and declined patients was similar between treatment groups for all scale scores except Cognition where perampanel patients had significantly fewer patients who declined compared to SOC (19.32% v 27.04%, p=0.043). On all 8 scale scores, the proportion of QOL responders was higher among 50% seizure responders on perampanel than SOC: Energy (46.25 v 28.95%), Mood (45.68 v 27.50%), Daily Activities (43.53 v 25.53%), Cognition (35.37 v 25.97%), Medication Effects (41.57 v 27.27%), Seizure Worry (40.96 v 31.88%), Overall QOL (44.09 v 30.00%), and QOLIE-31-P Total Score (43.40 v 35.56%). Conclusions: The results support the conclusion that perampanel provides improved seizure control (Epilepsia 2013;54:1481-1489) and reduced cognitive decline without worsening HRQL compared to SOC. Additionally, there were numerically higher proportions of QOL responders among 50% seizure responders on perampanel than SOC on all scales of the QOLIE-31-P.