Abstracts

Rationale: Clinical trial evidence for the use of antiseizure medications (ASMs) in patients with epilepsy with vascular etiology is currently limited. Real-world evidence from clinical practice studies is therefore required in order to inform treatment decisions in this patient group. Perampanel (PER) is a once-daily oral ASM for focal-onset seizures, with or without focal to bilateral tonic-clonic seizures, and generalized tonic-clonic seizures. The purpose of this study was to assess the real-world effectiveness, safety and tolerability of PER when used in everyday clinical practice to treat patients with epilepsy with vascular etiology.

Methods: Patients with epilepsy with vascular etiology were identified from a pooled analysis of 44 prospective, retrospective and cross-sectional clinical practice studies/work groups. Retention was assessed after 3, 6 and 12 months of PER treatment. Effectiveness was assessed by seizure type (focal-onset, focal to bilateral tonic-clonic) at the last visit (last observation carried forward). Effectiveness assessments comprised responder rate (≥ 50% seizure frequency reduction), seizure freedom rate (no seizures since at least the prior visit), and the proportions of patients with unchanged or worsening seizure frequency. Safety and tolerability were assessed by evaluating adverse events (AEs), psychiatric AEs, and AEs leading to discontinuation.

Results: One hundred patients with focal-onset or focal to bilateral tonic-clonic seizures with vascular etiology were identified (mean age, 58 years; 60.2% male; mean duration of epilepsy, 8.3 years). Seizure types at baseline were focal-onset (91.0%) and focal to bilateral tonic-clonic seizures (9.0%). Overall, 70.7% of patients received PER as adjunctive therapy and 29.3% as monotherapy. Mean (standard deviation) PER doses at baseline and last visit were 3.5 (1.7) and 5.2 (2.2) mg/day, respectively. Retention was assessed for 93 patients; effectiveness for 95 patients; safety and tolerability for 97 patients. At 3, 6 and 12 months, retention rates were 92.5% (86/93), 83.5% (76/91) and 72.8% (59/81), respectively. Reasons for discontinuation included AEs (16.0%), lack of efficacy (6.2%), and both AEs and lack of efficacy (1.2%). Mean (95% confidence interval) time under PER treatment was 11.6 (10.6–12.5) months. At the last visit, seizure freedom rates in patients with focal-onset and focal to bilateral tonic-clonic seizures were 50.6% and 12.5%, respectively, and corresponding values for responder rates were 70.6% and 66.7%, respectively (Figure). AEs were reported for 47.4% of patients; the most frequently reported AEs (≥ 10% of patients) were dizziness/vertigo (15.5%), somnolence (15.5%) and irritability (13.4%) (Table). Psychiatric AEs were reported for 21.6% of patients, and 17.3% of patients discontinued due to AEs over 12 months.

Conclusions: PER was effective and generally well tolerated when used to treat patients with epilepsy with vascular etiology in clinical practice.

Funding: Please list any funding that was received in support of this abstract.: Supported by Eisai.