Efficacy and tolerability of treatment with lacosamide in children: Postmarketing experience from the Middle East
Loading...
Files
Date
Journal Title
Journal ISSN
Volume Title
Publisher
W.B. Saunders Ltd
Abstract
Purpose: The aim of this study was to evaluate the tolerability and efficacy of lacosamide (LCM) in Lebanese children with focal-onset seizures and to determine if specific variables are predictive of better effectiveness. Methods: This is a retrospective analysis from three medical centers on consecutive children diagnosed with focal onset seizures and initiated on LCM. The seizure frequencies following the introduction of LCM were recorded and compared to the baseline monthly frequency at 3, 6, 12, 18, and 24 months. The primary efficacy variables were the 50% responder and seizure-free rates. The secondary outcome variables included the terminal 6-month seizure remission and percentages of discontinuation due to lack of efficacy or tolerability. Results: 58 patients with a mean age of 10 years experiencing a mean of 36.2 seizures per month during baseline were included. The seizure-free rates were 32.8%, 29.7%, and 12.5% at 6, 12 and 24 months follow up, respectively. Patients concomitantly treated with a sodium channel blocker were less likely to achieve a terminal 6-month seizure remission while the early introduction of LCM resulted in a significantly higher likelihood of attaining such a remission. 74.1% of patients were still maintained on LCM at the last follow-up. The most common adverse events consisted of dizziness, somnolence, nausea, vomiting, and rarely double vision. Conclusions: LCM is efficacious and overall well tolerated in children with focal-onset seizures and exhibits higher efficacy with early introduction and when added to a non-sodium channel blocker. © 2020 British Epilepsy Association
Description
Keywords
Antiepileptic drugs, Children, Lacosamide, Phase iv trial, Anticonvulsants, Child, Epilepsies, partial, Female, Follow-up studies, Humans, Lebanon, Male, Outcome assessment, health care, Product surveillance, postmarketing, Retrospective studies, Anticonvulsive agent, Adult, Article, Controlled study, Diplopia, Dizziness, Drug dose increase, Drug efficacy, Drug safety, Drug tolerability, Drug withdrawal, Focal epilepsy, Follow up, Human, Lebanese, Major clinical study, Middle east, Nausea, Outcome assessment, Priority journal, Remission, Retrospective study, Somnolence, Vomiting, Clinical trial, Phase 4 clinical trial, Postmarketing surveillance