Abstract
Background: As a third-generation antiseizure medication (ASM), lacosamide (LCM) is recommended worldwide for patients with epilepsy. We aimed to provide more conclusive evidence for the safety and tolerability of LCM in patients with epilepsy.Methods: A systematic search was performed on MEDLINE, Embase, Cochrane Library, CBM, CNKI, IDB, VIP Database, and Wanfang Database from inception to 2021 March, and all studies assessing the safety of LCM were included. A meta-analysis was performed for safety data of LCM.Results: Eighty-three studies involving 12268 populations (11 randomized clinical trials (RCTs), 16 cohort studies, 53 case series, and 3 case reports) were included in our study. Meta-analysis of the total incidence of adverse events (AEs) of LCM was 38.7% [95% CI (35.1%, 45.8%); n=75 studies]. Incidence of withdrawal due to AEs was 10.8% [95% CI (9.1%, 12.6%); n=56 studies], and incidence of serious adverse events (SAEs) was 6.5% [95% CI (4.0%, 8.9%); n=13 studies]. Most AEs were in the nervous system and digestive system. The most common AEs were sedation (15.8%), dizziness (15.7%), fatigue (9.4%), and nausea/vomiting (9.3%). For children, the total incidence of AEs of LCM was 32.8% [95% CI (21.6%, 44.0%); n=16 studies], and the most common AEs were dizziness (8.6%), nausea/vomiting (8.6%), and somnolence (6.8%).Conclusion: Lacosamide is generally safe and well tolerated in patients with epilepsy. Common AEs were sedation, dizziness, and fatigue. It is necessary to pay more attention to the prevention and management of these AEs and conduct more large-scale and high-quality studies to update safety data.
Highlights
Epilepsy is one of the most common neurological disorders, affecting over 50 million people worldwide (U.S National Library of Medicine, 2020)
Lacosamide Versus Zonisamide We identified two cohort studies (Brodie et al, 2014; Sarkis et al, 2017) that compared the incidence of AEs between LCM and ZNS use
Lacosamide Versus Perampanel We identified one study (Kurth et al, 2017) that focused on safety outcomes of LCM and PER use
Summary
Epilepsy is one of the most common neurological disorders, affecting over 50 million people worldwide (U.S National Library of Medicine, 2020). According to a meta-analysis, the prevalence of epilepsy among the general population is 7‰ worldwide, which ranged from 2.3 to 15.9 per 1,000 in developed countries and from 3.6 to 15.4 per 1,000 in developing countries Approximately one-third of patients do not achieve complete control of seizures with currently available ASMs (Moshe et al, 2015). As a third generation antiseizure medication (ASM), lacosamide (LCM) enhances the slow inactivation of voltagegated sodium channels. Classic ASMs such as oxcarbazepine (OXZ), carbamazepine (CBZ), and lamotrigine (LTC) target sodium channels, acting on their fast inactivation; LCM has a unique structure and is currently the only highly selective blocker that acts on slow inactivation of sodium channels. As a third-generation antiseizure medication (ASM), lacosamide (LCM) is recommended worldwide for patients with epilepsy. We aimed to provide more conclusive evidence for the safety and tolerability of LCM in patients with epilepsy
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