Safety and effectiveness of perampanel monotherapy after adjunctive therapy through retention rate in subjects with focal-onset seizures with or without focal to bilateral tonic-clonic seizures: A multicenter retrospective study in Korea

• Published in: Epilepsy & behavior Vol. 145; p. 109291
• Main Authors: Lim, Sung Chul, Lee, Won Gu, Kim, Dong Wook, Kim, Kwang Ki, Shon, Young-Min, Park, Jihyun, Lee, Yoona, Seo, Dae-Won
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.08.2023
• Subjects: Antiepileptic drug; Focal-onset seizures; Monotherapy; Perampanel; Retention rate; Antiepileptic drug; Retention rate; Focal-onset seizures; Monotherapy; Perampanel
• ISSN: 1525-5050; 1525-5069; 1525-5069
• DOI: 10.1016/j.yebeh.2023.109291

•Perampanel can be used as initial monotherapy and as add-on therapy.•The effect of converting to perampanel monotherapy from add-on therapy is unknown.•This was a non-interventional study in Korean patients with focal-onset seizures.•Conversion to perampanel monotherapy from adjunctive therapy was effective.•Perampanel was well tolerated and no new safety signals were identified. To assess the effectiveness and tolerability of perampanel monotherapy following conversion from adjunctive therapy. This was a multicenter, retrospective, non-interventional study of Korean patients aged ≥12 years with focal-onset seizures (FOS) with or without focal to bilateral tonic-clonic seizures. Data were extracted from electronic medical records of perampanel-treated patients from 1 February 2016 to 31 October 2020. Kaplan–Meier estimated retention rates, effectiveness, and safety were recorded. Subjects (n = 66, mean age 46.2 years) were mostly male (68.2%) with focal to bilateral tonic-clonic seizure (71.2%). Mean duration of illness was 86.3 months. Retention rates after conversion to perampanel monotherapy at 3, 6, and 12 months (primary outcome) were 96.0%, 96.0%, and 75.6%, respectively. Overall retention rates in patients receiving perampanel as adjunctive or monotherapy at 3, 6, 12, 18, and 24 months after perampanel add-on were 100%, 98.3%, 95.9%, 92.6%, and 92.6%, respectively. Mean retention duration was 41.2 months (overall perampanel administration) and 21.4 months (monotherapy). Mean seizure frequency/28 days in the Full Analysis Set (n = 61) was comparable for adjunctive and monotherapy (0.2 ± 0.79 vs 0.2 ± 0.64; change between adjunctive and monotherapy periods: 0.0 ± 0.59; p = 0.498). Perampanel was well tolerated and no new safety signals were identified. Dizziness (4.6%), only reported during adjunctive therapy, was the most common treatment-emergent adverse event. Conversion to perampanel monotherapy from adjunctive therapy showed promising results in subjects with FOS with/without focal to bilateral tonic-clonic seizures; further studies in a larger population are needed to confirm these encouraging data.