학술논문
Perampanel in routine clinical use in idiopathic generalized epilepsy: The 12-month GENERAL study.
Document Type
Academic Journal
Author
Villanueva V; University Hospital and Polytechnic La Fe, Valencia, Spain.; Montoya J; Lluis Alcanyis Hospital, Xátiva, Spain.; General University Hospital Valencia, Valencia, Spain.; Castillo A; General University Hospital Valencia, Valencia, Spain.; Mauri-Llerda JÁ; University Hospital Clinic Lozano Blesa, Zaragoza, Spain.; Giner P; University Hospital Dr Peset, Valencia, Spain.; López-González FJ; University Hospital Complex Santiago, Santiago de Compostela, Spain.; Piera A; University Hospital Clinic Valencia, Valencia, Spain.; Villanueva-Hernández P; University Hospital Bellvitge, Barcelona, Spain.; Bertol V; University Hospital Miguel Servet, Zaragoza, Spain.; Garcia-Escrivá A; IMED Levante Hospital, Benidorm, Spain.; Garcia-Peñas JJ; Niño Jesus University Children's Hospital, Madrid, Spain.; Garamendi I; University Hospital Cruces, Bilbao, Spain.; Esteve-Belloch P; Verge de la Cinta Hospital, Tortosa, Spain.; Baiges-Octavio JJ; Verge de la Cinta Hospital, Tortosa, Spain.; Miró J; University Hospital Bellvitge, Barcelona, Spain.; Falip M; University Hospital Bellvitge, Barcelona, Spain.; Garcés M; University Hospital and Polytechnic La Fe, Valencia, Spain.; Gómez A; University Hospital and Polytechnic La Fe, Valencia, Spain.; Gil-López FJ; Hospital Clinic Barcelona, Barcelona, Spain.; Carreño M; Hospital Clinic Barcelona, Barcelona, Spain.; Rodriguez-Uranga JJ; Advanced Neurology Center, Sevilla, Spain.; Campos D; University Hospital Clinic, Valladolid, Spain.; Bonet M; Arnau de Vilanova Hospital, Valencia, Spain.; Querol R; University Complex Infanta Cristina, Badajoz, Spain.; Molins A; University Hospital Josep Trueta, Girona, Spain.; Tortosa D; University Hospital Virgen Arraixaca, Murcia, Spain.; Salas-Puig J; University Hospital Vall d'Hebrón, Barcelona, Spain.
Source
Publisher: Blackwell Science Country of Publication: United States NLM ID: 2983306R Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1528-1167 (Electronic) Linking ISSN: 00139580 NLM ISO Abbreviation: Epilepsia Subsets: MEDLINE
Subject
Language
English
Abstract
Objective: To analyze the effectiveness and tolerability of perampanel across different seizure types in routine clinical care of patients with idiopathic generalized epilepsy (IGE).
Methods: This multicenter, retrospective, 1-year observational study collected data from patient records at 21 specialist epilepsy units in Spain. All patients who were aged ≥12 years, prescribed perampanel before December 2016, and had a confirmed diagnosis of IGE were included.
Results: The population comprised 149 patients with IGE (60 with juvenile myoclonic epilepsy, 51 generalized tonic-clonic seizures [GTCS] only, 21 juvenile absence epilepsy, 10 childhood absence epilepsy, 6 adulthood absence epilepsy, and one Jeavons syndrome). Mean age was 36 years. The retention rate at 12 months was 83% (124/149), and 4 mg was the most common dose. At 12 months, the seizure-free rate was 59% for all seizures (88/149); 63% for GTCS (72/115), 65% for myoclonic seizures (31/48), and 51% for absence seizures (24/47). Seizure frequency was reduced significantly at 12 months relative to baseline for GTCS (78%), myoclonic (65%), and absence seizures (48%). Increase from baseline seizure frequency was seen in 5.2% of patients with GTCS seizures, 6.3% with myoclonic, and 4.3% with absence seizures. Perampanel was effective regardless of epilepsy syndrome, concomitant antiepileptic drugs (AEDs), and prior AEDs, but retention and seizure freedom were significantly higher when used as early add-on (after ≤2 prior AEDs) than late (≥3 prior AEDs). Adverse events were reported in 50% of patients over 12 months, mostly mild or moderate, and irritability (23%), somnolence (15%), and dizziness (14%) were most frequent.
Significance: In routine clinical care of patients with IGE, perampanel improved seizure outcomes for GTCS, myoclonic seizures, and absence seizures, with few discontinuations due to adverse events. This is the first real-world evidence with perampanel across different seizure types in IGE.
(Wiley Periodicals, Inc. © 2018 International League Against Epilepsy.)
Methods: This multicenter, retrospective, 1-year observational study collected data from patient records at 21 specialist epilepsy units in Spain. All patients who were aged ≥12 years, prescribed perampanel before December 2016, and had a confirmed diagnosis of IGE were included.
Results: The population comprised 149 patients with IGE (60 with juvenile myoclonic epilepsy, 51 generalized tonic-clonic seizures [GTCS] only, 21 juvenile absence epilepsy, 10 childhood absence epilepsy, 6 adulthood absence epilepsy, and one Jeavons syndrome). Mean age was 36 years. The retention rate at 12 months was 83% (124/149), and 4 mg was the most common dose. At 12 months, the seizure-free rate was 59% for all seizures (88/149); 63% for GTCS (72/115), 65% for myoclonic seizures (31/48), and 51% for absence seizures (24/47). Seizure frequency was reduced significantly at 12 months relative to baseline for GTCS (78%), myoclonic (65%), and absence seizures (48%). Increase from baseline seizure frequency was seen in 5.2% of patients with GTCS seizures, 6.3% with myoclonic, and 4.3% with absence seizures. Perampanel was effective regardless of epilepsy syndrome, concomitant antiepileptic drugs (AEDs), and prior AEDs, but retention and seizure freedom were significantly higher when used as early add-on (after ≤2 prior AEDs) than late (≥3 prior AEDs). Adverse events were reported in 50% of patients over 12 months, mostly mild or moderate, and irritability (23%), somnolence (15%), and dizziness (14%) were most frequent.
Significance: In routine clinical care of patients with IGE, perampanel improved seizure outcomes for GTCS, myoclonic seizures, and absence seizures, with few discontinuations due to adverse events. This is the first real-world evidence with perampanel across different seizure types in IGE.
(Wiley Periodicals, Inc. © 2018 International League Against Epilepsy.)