Efficacy and safety of levetiracetam as adjunctive therapy for refractory focal epilepsy

• Published in: Arquivos de neuro-psiquiatria Vol. 79; no. 4; pp. 290 - 298
• Main Authors: MANREZA, Maria Luiza Giraldes de, PAN, Tatiane Amaral, CARBONE, Eduardo Quinalha, VATTIMO, Antonio Carlos Amedeo, HERRERA, Renata, MORAIS, Douglas Costa, CARDOSO, Rita Antonelli, LACERDA, Glenda Corrêa Borges de, LIN, Katia, NAKANO, Frederico Nakane, KOWACS, Pedro André, PALMINI, André Luis Fernandes, SOUZA, Adélia Maria de Miranda Henriques, ZUNG, Stevin, YACUBIAN, Elza Márcia Targas
• Format: Journal Article
• Language: English; Portuguese
• Published: Rua do Matoso 170, Rio de Janeiro, RJ, CEP 20270-135, Brazil Thieme Revinter Publicações Ltda 01.04.2021; Arquivos de Neuro-Psiquiatria; Academia Brasileira de Neurologia - ABNEURO; Academia Brasileira de Neurologia (ABNEURO)
• Subjects: Adult; Adverse events; Anticonvulsants - therapeutic use; Antiseizure Medications; Child; Children; Convulsions & seizures; Double-Blind Method; Drug Resistant Epilepsy; Drug Therapy, Combination; Epilepsies, Partial; Epilepsy; Etiracetam; Focal Seizures; Humans; Levetiracetam; Levetiracetam - therapeutic use; Morbidity; NEUROSCIENCES; Patients; Placebos; PSYCHIATRY; Quality of Life; Refractory Epilepsy; Safety; Seizures; Treatment Outcome; Focal Seizures; Antiseizure Medications; Fármacos Anticrise; Epilepsia Refratária; Crises Focais; Refractory Epilepsy; Levetiracetam; Seizures; Crises Epilépticas
• ISSN: 0004-282X; 1678-4227; 1678-4227
• DOI: 10.1590/0004-282X-ANP-2020-0082

ABSTRACT Background: Epilepsy affects about 50 million people worldwide and around 30% of these patients have refractory epilepsy, with potential consequences regarding quality of life, morbidity and premature mortality. Objective: The aim of treatment with antiseizure medications (ASMs) is to allow patients to remain without seizures, with good tolerability. Levetiracetam is a broad-spectrum ASM with a unique mechanism of action that differs it from other ASMs. It has been shown to be effective and safe for treating adults and children with epilepsy. Methods: This was a phase III, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of levetiracetam in children and adults (4-65 years) as an adjuvant treatment for focal-onset seizures. It was conducted among 114 patients undergoing treatment with up to three ASMs. The primary efficacy analysis was based on the proportion of patients who achieved a reduction of ≥ 50% in the mean number of focal seizures per week, over a 16-week treatment period. The patients were randomized to receive placebo or levetiracetam, titrated every two weeks from 20 mg/kg/day or 1,000 mg/day up to 60 mg/kg/day or 3,000 mg/day. Results: Levetiracetam was significantly superior to placebo (p = 0.0031); 38.7% of the participants in the levetiracetam group and 14.3% in the control group shows reductions in focal seizures. Levetiracetam was seen to have a favorable safety profile and an adverse event rate similar to that of placebo. Conclusion: Corroborating the results in the literature, levetiracetam was shown to be effective and safe for children and adults with refractory focal-onset epilepsy.