Perampanel for the Treatment of Patients with Myoclonic Seizures in Clinical Practice
Abstract number :
V.053
Submission category :
4. Clinical Epilepsy / 4C. Clinical Treatments
Year :
2021
Submission ID :
1825954
Source :
www.aesnet.org
Presentation date :
12/9/2021 12:00:00 PM
Published date :
Nov 22, 2021, 06:51 AM
Authors :
Hsing-I Chiang, MD - Chang Gung Memorial Hospital, Linkou, Taiwan; Rodrigo Rocamora - Epilepsy Unit, Hospital del Mar, Barcelona, Spain; Ascension Castillo - General University Hospital Valencia, Valencia, Spain; Eugen Trinka - Department of Neurology, Christian-Doppler University Hospital, Paracelsus Medical University, Salzburg, Austria; Wendyl D'Souza - Department of Medicine, St Vincent's Hospital Melbourne, The University of Melbourne, Victoria, Australia; Samantha Goldman - Eisai Europe Ltd, Hatfield, Hertfordshire, UK; Vicente Villanueva - Refractory Epilepsy Unit, Hospital Universitario y Politécnico La Fe, Valencia, Spain
Rationale: Myoclonic seizures may be present in different epilepsy syndromes, including some idiopathic generalized epilepsies. Perampanel 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. The purpose of this study was to assess the effectiveness, safety and tolerability of PER when used to treat patients with myoclonic seizures in everyday clinical practice.
Methods: Patients with myoclonic seizures who were treated with PER were identified from a pooled analysis of 44 clinical practice studies/work groups. Retention was assessed after 3, 6 and 12 months. 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: 156 patients with myoclonic seizures were identified. Patients had a range of epileptic syndromes; most commonly ( >10% of patients), juvenile myoclonic epilepsy (72.9%) and idiopathic generalized epilepsy (13.2%) (Table). Retention was assessed for 133 patients; effectiveness for 142 patients; and safety/tolerability for 156 patients. Mean (standard deviation) PER dose was 2.6 (1.1) mg/day at baseline and 5.5 (2.1) mg/day at the last visit (last observation carried forward). Retention rates at 3, 6 and 12 months were 94.7% (126/133), 89.0% (113/127) and 80.7% (92/114), respectively. Reasons for discontinuation included AEs (11.4%), lack of efficacy (4.4%), and both AEs and lack of efficacy (2.6%). Mean (95% confidence interval) time under PER treatment was 12.1 (11.4–12.7) months. At the last visit, responder and seizure freedom rates were 85.9% and 63.4%, respectively; and the proportions of patients with unchanged and worsening seizure frequency were 10.2% and 3.1%, respectively (Figure). AEs were reported for 46.8% (73/156) of patients and psychiatric AEs were reported for 24.7% (38/154) of patients. The most frequently reported AEs ( >5% of patients) were dizziness/vertigo (19.2%), somnolence (18.6%) and fatigue (9.6%). At 12 months, 14.0% (16/114) of patients had discontinued due to AEs.
Conclusions: PER was effective and generally well tolerated when used to treat patients with myoclonic seizures in everyday clinical practice. Almost two-thirds of patients achieved seizure freedom at the last visit.
Funding: Please list any funding that was received in support of this abstract.: Supported by Eisai.
Clinical Epilepsy