PMID- 34616294 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20211008 IS - 1663-9812 (Print) IS - 1663-9812 (Electronic) IS - 1663-9812 (Linking) VI - 12 DP - 2021 TI - Safety and Tolerability of Lacosamide in Patients With Epilepsy: A Systematic Review and Meta-Analysis. PG - 694381 LID - 10.3389/fphar.2021.694381 [doi] LID - 694381 AB - 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. CI - Copyright (c) 2021 Yang, Peng, Zhang and Zhao. FAU - Yang, Chunsong AU - Yang C AD - Department of Pharmacy, Evidence-Based Pharmacy Center, West China Second Hospital, Sichuan University, Chengdu, China. AD - Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University), Ministry of Education, Chengdu, China. FAU - Peng, Yuxuan AU - Peng Y AD - West China School of Pharmacy, Sichuan University, Chengdu, China. FAU - Zhang, Lingli AU - Zhang L AD - Department of Pharmacy, Evidence-Based Pharmacy Center, West China Second Hospital, Sichuan University, Chengdu, China. AD - Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University), Ministry of Education, Chengdu, China. FAU - Zhao, Li AU - Zhao L AD - Department of Health Policy and Management, West China School of Public Health/West China Fourth Hospital, Sichuan University, Chengdu, China. LA - eng PT - Journal Article DEP - 20210920 PL - Switzerland TA - Front Pharmacol JT - Frontiers in pharmacology JID - 101548923 PMC - PMC8488108 OTO - NOTNLM OT - epilepsy OT - lacosamide OT - meta-analysis OT - safety OT - systematic review COIS- The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. EDAT- 2021/10/08 06:00 MHDA- 2021/10/08 06:01 PMCR- 2021/09/20 CRDT- 2021/10/07 06:54 PHST- 2021/04/14 00:00 [received] PHST- 2021/08/23 00:00 [accepted] PHST- 2021/10/07 06:54 [entrez] PHST- 2021/10/08 06:00 [pubmed] PHST- 2021/10/08 06:01 [medline] PHST- 2021/09/20 00:00 [pmc-release] AID - 694381 [pii] AID - 10.3389/fphar.2021.694381 [doi] PST - epublish SO - Front Pharmacol. 2021 Sep 20;12:694381. doi: 10.3389/fphar.2021.694381. eCollection 2021.