Rafael Toledano Delgado1,2, Irene García-Morales2,3, Beatriz Parejo-Carbonell3, Adolfo Jiménez-Huete4, David Herrera-Ramirez2, Ayoze González-Hernández5, Fernando Ayuga Loro6, Estevo Santamarina7, Manuel Toledo7, Joaquín Ojeda8, Juan José Poza9, Albert Molins10, Pau Giner11, José Carlos Estévez María12, María Dolores Castro-Vilanova13, Jorge Zurita14, Rosa Ana Saiz-Diaz15, Asier Gómez-Ibañez16, Juan Rodriguez-Uranga17, Antonio Gil-Nagel2, Dulce Campos18, Álvaro Sánchez-Larsen19, Maria José Aguilar-Amat Prior20, José Angel Mauri Llerda21, Nuria Huertas González22, Nuria García-Barragán1. 1. Epilepsy Unit, Neurology Department, Hospital Ramón y Cajal, Madrid, Spain. 2. Epilepsy Unit, Neurology Department, Hospital Ruber Internacional, Madrid, Spain. 3. Epilepsy Unit, Neurology Department, Hospital Clínico San Carlos, Madrid, Spain. 4. Neurology Department, Hospital Ruber Internacional, Madrid, Spain. 5. Neurology Department, Hospital San Roque Las Palmas, Las Palmas de Gran Canaria, Spain. 6. Neurology Department, Complejo Hospitalario de Toledo, Toledo, Spain. 7. Epilepsy Unit, Neurology Department, Hospital Vall d´Hebron, Barcelona, Spain. 8. Neurology Department, Hospital Infanta Sofía, Madrid, Spain. 9. Neurology Department, Hospital Donostia, San Sebastian, Spain. 10. Neurology Department, Hospital Josep Trueta, Girona, Spain. 11. Neurology Department, Hospital Dr. Peset, Valencia, Spain. 12. Neurology Department, Hospital Reina Sofía, Cordoba, Spain. 13. Neurology Department, Hospital Álvaro Cunqueiro, Vigo, Spain. 14. Neurology Department, Hospital Infanta Leonor, Madrid, Spain. 15. Neurology Department, Hospital 12 de Octubre, Madrid, Spain. 16. Neurology Department, Clínica Universitaria de Navarra, Madrid, Spain. 17. Epilepsy Unit, Neurology Department, Centro de Neurología Avanzada, Seville, Spain. 18. Neurology Department, Hospital Clínico de Valladolid, Valladolid, Spain. 19. Neurology Department, Complejo Hospitalario de Albacete, Albacete, Spain. 20. Neurology Department, Hospital La Paz, Madrid, Spain. 21. Neurology Department, Hospital Lozano Blesa, Zaragoza, Spain. 22. Neurology Department, Hospital Severo Ochoa, Madrid, Spain.
Abstract
OBJECTIVE: To assess the effectiveness and tolerability of perampanel (PER) monotherapy in routine clinical practice for the treatment of focal onset and generalized tonic-clonic seizures (GTCS). METHODS: This multicenter, retrospective, observational study was conducted in patients aged ≥12 years treated with PER as primary monotherapy or converted to PER monotherapy by progressive reduction of background antiepileptic drugs. Outcomes included retention, responder, and seizure-free rate after 3, 6, and 12 months and tolerability throughout the follow-up. RESULTS: A total of 98 patients (mean age = 49.6 ± 21.7 years, 51% female) with focal seizures and/or GTCS were treated with PER monotherapy for a median exposure of 14 months (range = 1-57) with a median dose of 4 mg (range = 2-10). The retention rates at 3, 6, and 12 months and last follow-up were 93.8%, 89.3%, 80.9%, and 71.4%, respectively. The retention rates according to the type of monotherapy (primary vs conversion) did not differ (log-rank P value = .57). Among the 98 patients, 61.2% patients had seizures throughout the baseline period, with a median seizure frequency of 0.6 seizures per month (range = 0.3-26). Responder rates at 3, 6, and 12 months were 79.6%, 70.1%, and 52.8%, respectively, and seizure freedom rates at the same points were 62.7%, 56.1%, and 41.5%. Regarding the 33 patients who had GTCS in the baseline period, 87.8% were seizure-free at 3 months, 78.1% at 6 months, and 55.1% at 12 months. Over the entire follow-up, PER monotherapy was generally well tolerated, and only 16% of patients discontinued PER due to adverse events (AEs). Female patients were found to be at a higher risk of psychiatric AEs (female vs male odds ratio = 2.85, 95% confidence interval = 1-8.33, P = .046). SIGNIFICANCE: PER demonstrated good effectiveness and a good safety profile when used as primary therapy or conversion to monotherapy at relatively low doses, in a clinical setting with patients with focal seizures and GTCS.
OBJECTIVE: To assess the effectiveness and tolerability of perampanel (PER) monotherapy in routine clinical practice for the treatment of focal onset and generalized tonic-clonic seizures (GTCS). METHODS: This multicenter, retrospective, observational study was conducted in patients aged ≥12 years treated with PER as primary monotherapy or converted to PER monotherapy by progressive reduction of background antiepileptic drugs. Outcomes included retention, responder, and seizure-free rate after 3, 6, and 12 months and tolerability throughout the follow-up. RESULTS: A total of 98 patients (mean age = 49.6 ± 21.7 years, 51% female) with focal seizures and/or GTCS were treated with PER monotherapy for a median exposure of 14 months (range = 1-57) with a median dose of 4 mg (range = 2-10). The retention rates at 3, 6, and 12 months and last follow-up were 93.8%, 89.3%, 80.9%, and 71.4%, respectively. The retention rates according to the type of monotherapy (primary vs conversion) did not differ (log-rank P value = .57). Among the 98 patients, 61.2% patients had seizures throughout the baseline period, with a median seizure frequency of 0.6 seizures per month (range = 0.3-26). Responder rates at 3, 6, and 12 months were 79.6%, 70.1%, and 52.8%, respectively, and seizure freedom rates at the same points were 62.7%, 56.1%, and 41.5%. Regarding the 33 patients who had GTCS in the baseline period, 87.8% were seizure-free at 3 months, 78.1% at 6 months, and 55.1% at 12 months. Over the entire follow-up, PER monotherapy was generally well tolerated, and only 16% of patients discontinued PER due to adverse events (AEs). Female patients were found to be at a higher risk of psychiatric AEs (female vs male odds ratio = 2.85, 95% confidence interval = 1-8.33, P = .046). SIGNIFICANCE: PER demonstrated good effectiveness and a good safety profile when used as primary therapy or conversion to monotherapy at relatively low doses, in a clinical setting with patients with focal seizures and GTCS.