Objective: Post-stroke epilepsy (PSE) is one of the most common causes of acquired epilepsy and accounts for about 10-15% of all newly diagnosed epilepsy cases. However, evidence about the clinical profile of antiseizure medications in the PSE setting is currently limited. Brivaracetam (BRV) is a rationally developed compound characterized by high-affinity binding to synaptic vesicle protein 2A. The aim of this study was to assess the 12-month effectiveness and tolerability of adjunctive BRV in patients with PSE treated in a real-world setting. Methods: This was a subgroup analysis of patients with PSE included in the BRIVAracetam add-on First Italian netwoRk Study (BRIVAFIRST). The BRIVAFIRST was a 12-month retrospective, multicentre study including adult patients prescribed adjunctive BRV. Effectiveness outcomes included the rates of seizure response (≥50% reduction in baseline seizure frequency), seizure‐freedom, and treatment discontinuation. Safety and tolerability outcomes included the rate of treatment discontinuation due to adverse events (AEs) and the incidence of AEs. Results: Patients with PSE included in the BRIVAFIRST were 75 and had a median age of 57 (interquartile range, 42-66) years. The median daily doses of BRV at 3, 6, and 12 months from starting treatment were 100 (100-150) mg, 125 (100-200) mg and 100 (100-200) mg, respectively. At 12 months, 32 (42.7%) patients had a reduction in their baseline seizure frequency by at least 50%, and the seizure freedom rates was 26/75 (34.7%). During the 1-year study period, 10 (13.3%) patients discontinued BRV. The reasons of treatment withdrawal were insufficient efficacy in 6 (8.0%) patients and poor tolerability in 4 (5.3%) patients. Adverse events were reported by 13 (20.3%) patients and were rated as mild in 84.6% and moderate in 15.4% of cases. Significance: Adjunctive BRV was efficacious and generally well-tolerated when used in patients with PSE in clinical practice. Adjunctive BRV can be a suitable therapeutic option for patients with PSE.
Brivaracetam as add-on treatment in patients with post-stroke epilepsy: real-world data from the BRIVAracetam add-on First Italian netwoRk Study (BRIVAFIRST) / S. Lattanzi, L. Canafoglia, M.P. Canevini, S. Casciato, E. Cerulli Irelli, V. Chiesa, F. Dainese, G. De Maria, G. Didato, G. Di Gennaro, G. Falcicchio, M. Fanella, E. Ferlazzo, M. Gangitano, A. La Neve, O. Mecarelli, E. Montalenti, A. Morano, F. Piazza, C. Pizzanelli, P. Pulitano, F. Ranzato, E. Rosati, L. Tassi, C. Di Bonaventura, A. Alicino, M. Ascoli, G. Assenza, F. Avorio, V. Badioni, P. Banfi, E. Bartolini, L.M. Basili, V. Belcastro, S. Beretta, I. Berto, M. Biggi, G. Billo, G. Boero, P. Bonanni, J. Bongiorno, F. Brigo, E. Caggia, C. Cagnetti, C. Calvello, E. Cesnik, G. Chianale, D. Ciampanelli, R. Ciuffini, D. Cocito, D. Colella, M. Contento, C. Costa, E. Cumbo, A. D'Aniello, F. Deleo, J.C. Difrancesco, R. Di Giacomo, A. Di Liberto, E. Domina, F. Dono, V. Durante, M. Elia, A. Estraneo, G. Evangelista, M.T. Faedda, Y. Failli, E. Fallica, J. Fattouch, A. Ferrari, F. Ferreri, G. Fisco, D. Fonti, F. Fortunato, N. Foschi, T. Francavilla, R. Galli, S. Gazzina, A.T. Giallonardo, F.S. Giorgi, L. Giuliano, F. Habetswallner, F. Izzi, B. Kassabian, A. Labate, C. Luisi, M. Magliani, G. Maira, L. Mari, D. Marino, A. Mascia, A. Mazzeo, C. Milano, S. Meletti, A. Nilo, B. Orlando, F. Paladin, M.G. Pascarella, C. Pastori, G. Pauletto, A. Peretti, G. Perri, M. Pezzella, M. Piccioli, P. Pignatta, N. Pilolli, F. Pisani, L.R. Pisani, F. Placidi, P. Pollicino, V. Porcella, S. Pradella, M. Puligheddu, S. Quadri, P.P. Quarato, R. Quintas, R. Renna, G.R. Rizzo, A. Rum, E.M. Salamone, E. Savastano, M. Sessa, D. Stokelj, E. Tartara, M. Tombini, G. Tumminelli, A.E. Vaudano, M. Ventura, I. Vigano, E. Viglietta, A. Vignoli, F. Villani, E. Zambrelli, L. Zummo. - In: SEIZURE. - ISSN 1059-1311. - 97:(2022 Apr), pp. 37-42. [10.1016/j.seizure.2022.03.007]
Brivaracetam as add-on treatment in patients with post-stroke epilepsy: real-world data from the BRIVAracetam add-on First Italian netwoRk Study (BRIVAFIRST)
M.P. Canevini;A. Vignoli;
2022
Abstract
Objective: Post-stroke epilepsy (PSE) is one of the most common causes of acquired epilepsy and accounts for about 10-15% of all newly diagnosed epilepsy cases. However, evidence about the clinical profile of antiseizure medications in the PSE setting is currently limited. Brivaracetam (BRV) is a rationally developed compound characterized by high-affinity binding to synaptic vesicle protein 2A. The aim of this study was to assess the 12-month effectiveness and tolerability of adjunctive BRV in patients with PSE treated in a real-world setting. Methods: This was a subgroup analysis of patients with PSE included in the BRIVAracetam add-on First Italian netwoRk Study (BRIVAFIRST). The BRIVAFIRST was a 12-month retrospective, multicentre study including adult patients prescribed adjunctive BRV. Effectiveness outcomes included the rates of seizure response (≥50% reduction in baseline seizure frequency), seizure‐freedom, and treatment discontinuation. Safety and tolerability outcomes included the rate of treatment discontinuation due to adverse events (AEs) and the incidence of AEs. Results: Patients with PSE included in the BRIVAFIRST were 75 and had a median age of 57 (interquartile range, 42-66) years. The median daily doses of BRV at 3, 6, and 12 months from starting treatment were 100 (100-150) mg, 125 (100-200) mg and 100 (100-200) mg, respectively. At 12 months, 32 (42.7%) patients had a reduction in their baseline seizure frequency by at least 50%, and the seizure freedom rates was 26/75 (34.7%). During the 1-year study period, 10 (13.3%) patients discontinued BRV. The reasons of treatment withdrawal were insufficient efficacy in 6 (8.0%) patients and poor tolerability in 4 (5.3%) patients. Adverse events were reported by 13 (20.3%) patients and were rated as mild in 84.6% and moderate in 15.4% of cases. Significance: Adjunctive BRV was efficacious and generally well-tolerated when used in patients with PSE in clinical practice. Adjunctive BRV can be a suitable therapeutic option for patients with PSE.
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