Autores: Delgado, R. T. (Autor de correspondencia); Garcia-Morales, I. ; Parejo-Carbonell, B. ;
Jiménez Huete, Adolfo; Herrera-Ramirez, D. ; Gonzalez-Hernandez, A. ; Loro, F. A. ; Santamarina, E. ; Toledo, M. ; Ojeda, J. ; Poza, J. J. ; Molins, A. ; Giner, P. ; Maria, J. C. E. ; Castro-Vilanova, M. D. ; Zurita, J. ; Saiz-Diaz, R. A. ;
Gómez Ibáñez, Asier; Rodriguez-Uranga, J. ; Gil-Nagel, A. ; Campos, D. ; Sanchez-Larsen, A. ; Prior, M. J. A. A. ; Llerda, J. A. M. ; Gonzalez, N. H. ; Garcia-Barragan, N.
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.
