Perampanel for the Treatment of Patients with Idiopathic Generalized Epilepsy in Clinical Practice
Abstract number :
3.216
Submission category :
4. Clinical Epilepsy / 4C. Clinical Treatments
Year :
2021
Submission ID :
1825956
Source :
www.aesnet.org
Presentation date :
12/6/2021 12:00:00 PM
Published date :
Nov 22, 2021, 06:51 AM
Authors :
Eugen Trinka, Prof - Department of Neurology, Christian-Doppler University Hospital, Paracelsus Medical University, Salzburg, Austria; Rajiv Mohanraj – Salford Royal NHS Foundation Trust, UK; Takaya Maeda – Eisai Co Ltd, Tokyo, Japan; Imad Najm – Cleveland Clinic Epilepsy Center, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA; Wendyl D'Souza – Department of Medicine, St Vincent's Hospital Melbourne, The University of Melbourne, Victoria, Australia; Vicente Villanueva – Refractory Epilepsy Unit, Hospital Universitario y Politécnico La Fe, Valencia, Spain
Rationale: Perampanel (PER) is a once-daily oral anti-seizure medication for focal-onset seizures, with or without focal to bilateral tonic-clonic seizures, and generalized tonic-clonic seizures. Further real-world evidence on the use of PER to specifically treat idiopathic generalized epilepsy (IGE) is needed. The purpose of this study was to assess the real-world effectiveness, safety and tolerability of PER when used to treat patients with IGE in everyday clinical practice.
Methods: Patients with IGE were identified from a pooled analysis of 44 prospective, retrospective and cross-sectional PER clinical practice studies/work groups. Retention was assessed after 3, 6 and 12 months of PER treatment. 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: A total of 540 patients with IGE were identified. Seizures types at baseline included generalized tonic clonic, myoclonic, absence and combinations of these. Retention was assessed for 494 patients; effectiveness for 463 patients; and safety/tolerability for 516 patients. Mean (standard deviation) PER dose was 2.5 (1.2) mg/day at baseline and 5.6 (2.4) mg/day at the last visit (last observation carried forward). Retention rates at 3, 6 and 12 months were 92.3% (456/494), 85.4% (373/437) and 77.4% (322/416), respectively. Reasons for discontinuation were AEs (11.3%), lack of efficacy (6.0%), and both AEs and lack of efficacy (1.0%). Mean (95% confidence interval) time under PER treatment was 11.9 (11.5–12.3) months. At the last visit, responder and seizure freedom rates were 74.2% and 54.6%, respectively; and the proportions of patients with unchanged and worsening seizure frequency were 11.3% and 5.9%, respectively (Figure). AEs were reported for 42.8% (221/516) of patients and psychiatric AEs were reported for 21.8% (112/514) of patients (Table). The most frequently reported AEs were irritability (14.5%), dizziness/vertigo (11.6%) and somnolence (9.9%). At 12 months, 12.3% (51/416) of patients had discontinued due to AEs.
Conclusions: PER was effective and generally well tolerated when used to treat patients with IGE in everyday clinical practice. At the last visit, over 50% of patients were seizure free.
Funding: Please list any funding that was received in support of this abstract.: Supported by Eisai.
Clinical Epilepsy