Abstracts

Rationale: Perampanel (PER) is a once-daily oral anti-seizure medication (ASM) for focal-onset seizures, with or without focal to bilateral tonic-clonic seizures, and generalized tonic-clonic seizures. Elderly patients are often excluded from clinical trials, due to high levels of comorbidity and associated comedications, and consequently there is limited information about the effects of PER in this population. The purpose of this study was to assess the effectiveness, safety and tolerability of PER in epilepsy patients aged ≥ 65 years treated in everyday clinical practice.

Methods: Patients aged ≥ 65 years 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 or generalized-onset) at the last visit (last observation carried forward). Effectiveness assessments included responder rate (≥ 50% seizure frequency reduction) and seizure freedom rate (no seizures since at least the prior visit). Safety and tolerability were assessed by evaluating adverse events (AEs), psychiatric AEs, and AEs leading to discontinuation.

Results: Three hundred and forty-two patients aged ≥ 65 years were identified (52.3% female; mean age, 72.4 years; mean number of previous ASMs, 3.6). The majority of patients (91.2%) had focal-onset seizures only; 5.8% had generalized-onset seizures only and 3.0% had both focal-onset and generalized-onset seizures. At treatment initiation the majority of patients were on 1 or 2 concomitant antiseizure medications; 13.1% initiated PER as monotherapy. Mean (standard deviation) PER dose was 2.6 (1.3) mg/day at baseline and 5.0 (2.1) mg/day at the last visit. Retention was assessed for 316 patients; effectiveness for 283 patients; and safety/tolerability for 299 patients. Retention rates at 3, 6 and 12 months were 86.7% (274/316), 76.5% (238/311) and 61.5% (179/291), respectively. Mean (95% confidence interval) time under PER treatment was 10.4 (9.8‒10.9) months. The most common reasons for discontinuation were AEs (22.0%), lack of efficacy (6.2%) and both AEs and lack of efficacy (1.7%). At the last visit, seizure freedom rates in patients with focal-onset and generalized-onset seizures were 38.2% and 53.3%, respectively; the corresponding values for responder rates were 69.3% and 76.9%, respectively (Figure). AEs were reported for 54.8% (164/299) of patients and the most frequently reported AEs (≥5% of patients) were dizziness/vertigo (16.4%), somnolence (12.0%) irritability (8.4%) and instability/ataxia (7.4%) (Table). Psychiatric AEs were reported for 18.5% (55/297) of patients, and 23.7% (69/291) of patients had discontinued due to AEs after 12 months.

Conclusions: PER was effective and generally well tolerated when used to treat elderly patients (≥65 years) in everyday clinical practice.

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