Vicente Villanueva1, Francisco Javier López-González2, José Angel Mauri3, Juan Rodriguez-Uranga4, Marta Olivé-Gadea5, Javier Montoya6, Jesus Ruiz-Giménez7, Jorge Zurita8. 1. La Fe University Hospital and Polytechnic, Valencia, Spain. 2. Clinical University Hospital, Santiago, Spain. 3. Lozano Blesa University Hospital, Zaragoza, Spain. 4. Advanced Neurological Centre, Sevilla, Spain. 5. Vall d'Hebron University Hospital, Barcelona, Spain. 6. Lluis Alcanyis Hospital, Xátiva, Spain. 7. Virgen de las Nieves University Hospital, Granada, Spain. 8. Infanta Leonor Hospital, Madrid, Spain.
Abstract
OBJECTIVES: Evaluate long-term effectiveness and tolerability of brivaracetam in clinical practice in patients with focal epilepsy. MATERIALS AND METHODS: This was a multicenter retrospective study. Patients aged ≥16 years were started on brivaracetam from November 2016 to June 2017 and followed over 1 year. Data were obtained from medical records at 3, 6 and 12 months after treatment initiation for evaluation of safety- and seizure-related outcomes. RESULTS: A total of 575 patients were included in analyses; most had been treated with ≥4 lifetime antiepileptic drugs. Target dosage was achieved by 30.6% of patients on the first day. Analysis of primary variables at 12 months revealed that mean reduction in seizure frequency was 36.0%, 39.7% of patients were ≥50% responders and 17.5% were seizure-free. Seizure-freedom was achieved by 37.5% of patients aged ≥65 years. Incidence of adverse events (AEs) and psychiatric AEs (PAEs) was 39.8% and 14.3%, respectively, and discontinuation due to these was 8.9% and 3.7%, respectively. Somnolence, irritability, and dizziness were the most frequently reported AEs. At baseline, 228 (39.7%) patients were being treated with levetiracetam; most switched to brivaracetam (dose ratio 1:10-15). Among those who switched because of PAEs (n = 53), 9 (17%) reported PAEs on brivaracetam, and 3 (5.7%) discontinued because of PAEs. Tolerability was not highly affected among patients with learning disability or psychiatric comorbidity. CONCLUSIONS: In a large population of patients with predominantly drug-resistant epilepsy, brivaracetam was effective and well-tolerated; no unexpected AEs occurred over 1 year, and the incidence of PAEs was lower compared with levetiracetam.
OBJECTIVES: Evaluate long-term effectiveness and tolerability of brivaracetam in clinical practice in patients with focal epilepsy. MATERIALS AND METHODS: This was a multicenter retrospective study. Patients aged ≥16 years were started on brivaracetam from November 2016 to June 2017 and followed over 1 year. Data were obtained from medical records at 3, 6 and 12 months after treatment initiation for evaluation of safety- and seizure-related outcomes. RESULTS: A total of 575 patients were included in analyses; most had been treated with ≥4 lifetime antiepileptic drugs. Target dosage was achieved by 30.6% of patients on the first day. Analysis of primary variables at 12 months revealed that mean reduction in seizure frequency was 36.0%, 39.7% of patients were ≥50% responders and 17.5% were seizure-free. Seizure-freedom was achieved by 37.5% of patients aged ≥65 years. Incidence of adverse events (AEs) and psychiatric AEs (PAEs) was 39.8% and 14.3%, respectively, and discontinuation due to these was 8.9% and 3.7%, respectively. Somnolence, irritability, and dizziness were the most frequently reported AEs. At baseline, 228 (39.7%) patients were being treated with levetiracetam; most switched to brivaracetam (dose ratio 1:10-15). Among those who switched because of PAEs (n = 53), 9 (17%) reported PAEs on brivaracetam, and 3 (5.7%) discontinued because of PAEs. Tolerability was not highly affected among patients with learning disability or psychiatric comorbidity. CONCLUSIONS: In a large population of patients with predominantly drug-resistant epilepsy, brivaracetam was effective and well-tolerated; no unexpected AEs occurred over 1 year, and the incidence of PAEs was lower compared with levetiracetam.
Authors: Simona Lattanzi; Michele Ascoli; Laura Canafoglia; Maria Paola Canevini; Sara Casciato; Emanuele Cerulli Irelli; Valentina Chiesa; Filippo Dainese; Giovanni De Maria; Giuseppe Didato; Giancarlo Di Gennaro; Giovanni Falcicchio; Martina Fanella; Massimo Gangitano; Angela La Neve; Oriano Mecarelli; Elisa Montalenti; Alessandra Morano; Federico Piazza; Chiara Pizzanelli; Patrizia Pulitano; Federica Ranzato; Eleonora Rosati; Laura Tassi; Carlo Di Bonaventura Journal: Epilepsia Date: 2022-03-26 Impact factor: 6.740