Effectiveness and safety of perampanel monotherapy for focal and generalized tonic-clonic seizures: Experience from a national multicenter registry
Por:
Toledano Delgado R, García-Morales I, Parejo-Carbonell B, Jiménez-Huete A, Herrera-Ramirez D, González-Hernández A, Ayuga Loro F, Santamarina E, Toledo M, Ojeda J, Poza JJ, Molins A, Giner P, Estévez María JC, Castro-Vilanova MD, Zurita J, Saiz-Diaz RA, Gómez-Ibañez A, Rodriguez-Uranga J, Gil-Nagel A, Campos D, Sánchez-Larsen Á, Aguilar-Amat Prior MJ, Mauri Llerda JA, Huertas González N and García-Barragán N
Publicada:
1 jun 2020
Ahead of Print:
1 jun 2020
Resumen:
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.
Filiaciones:
Toledano Delgado R:
Epilepsy Unit, Neurology Department, Hospital Ramón y Cajal, Madrid, Spain
Epilepsy Unit, Neurology Department, Hospital Ruber Internacional, Madrid, Spain
García-Morales I:
Epilepsy Unit, Neurology Department, Hospital Ruber Internacional, Madrid, Spain
Epilepsy Unit, Neurology Department, Hospital Clínico San Carlos, Madrid, Spain
Parejo-Carbonell B:
Epilepsy Unit, Neurology Department, Hospital Clínico San Carlos, Madrid, Spain
Jiménez-Huete A:
Neurology Department, Hospital Ruber Internacional, Madrid, Spain
Herrera-Ramirez D:
Epilepsy Unit, Neurology Department, Hospital Ruber Internacional, Madrid, Spain
González-Hernández A:
Neurology Department, Hospital San Roque Las Palmas, Las Palmas de Gran Canaria, Spain
Ayuga Loro F:
Neurology Department, Complejo Hospitalario de Toledo, Toledo, Spain
Santamarina E:
Epilepsy Unit, Neurology Department, Hospital Vall d´Hebron, Barcelona, Spain
Toledo M:
Epilepsy Unit, Neurology Department, Hospital Vall d´Hebron, Barcelona, Spain
Ojeda J:
Neurology Department, Hospital Infanta Sofía, Madrid, Spain
Poza JJ:
Neurology Department, Hospital Donostia, San Sebastian, Spain
Molins A:
Neurology Department, Hospital Josep Trueta, Girona, Spain
:
Neurology Department, Hospital Dr. Peset, Valencia, Spain
Estévez María JC:
Neurology Department, Hospital Reina Sofía, Cordoba, Spain
Castro-Vilanova MD:
Neurology Department, Hospital Álvaro Cunqueiro, Vigo, Spain
Zurita J:
Neurology Department, Hospital Infanta Leonor, Madrid, Spain
Saiz-Diaz RA:
Neurology Department, Hospital 12 de Octubre, Madrid, Spain
Gómez-Ibañez A:
Neurology Department, Clínica Universitaria de Navarra, Madrid, Spain
Rodriguez-Uranga J:
Epilepsy Unit, Neurology Department, Centro de Neurología Avanzada, Seville, Spain
Gil-Nagel A:
Epilepsy Unit, Neurology Department, Hospital Ruber Internacional, Madrid, Spain
Campos D:
Neurology Department, Hospital Clínico de Valladolid, Valladolid, Spain
Sánchez-Larsen Á:
Neurology Department, Complejo Hospitalario de Albacete, Albacete, Spain
Aguilar-Amat Prior MJ:
Neurology Department, Hospital La Paz, Madrid, Spain
Mauri Llerda JA:
Neurology Department, Hospital Lozano Blesa, Zaragoza, Spain
Huertas González N:
Neurology Department, Hospital Severo Ochoa, Madrid, Spain
García-Barragán N:
Epilepsy Unit, Neurology Department, Hospital Ramón y Cajal, Madrid, Spain
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