PMID- 27898363 OWN - NLM STAT- MEDLINE DCOM- 20170313 LR - 20170313 IS - 1532-2688 (Electronic) IS - 1059-1311 (Linking) VI - 45 DP - 2017 Feb TI - The adverse event profile of brivaracetam: A meta-analysis of randomized controlled trials. PG - 7-16 LID - S1059-1311(16)30214-X [pii] LID - 10.1016/j.seizure.2016.11.008 [doi] AB - PURPOSE: To comprehensively evaluate the adverse events (AEs) significantly associated with brivaracetam (BRV) treatment in a large selection of randomized control trials. METHODS: We conducted an online database search using Pubmed, Embase, Cochrane Online Library, and Clinicaltrial.gov for all available randomized control trials (RCTs) that investigated the therapeutic effects of brivaracetam. Serious AEs (SAEs), withdrawal, and treatment-emergent adverse effects were then assessed for their association with brivaracetam. Finally, a meta-analysis was performed using Review Manager 5.3 software. RESULTS: Eight RCTs with a total of 2505 patients were included in our study, 1178 of which were randomized with respect to brivaracetam (BRV). Serious AEs, overall withdrawal, AE-related withdrawal and psychiatric adverse events (PAEs) were not significantly associated with BRV treatment. BRV was also not significantly associated with a heightened risk of AE-related withdrawal and PAEs with increasing doses. Of the 17 AEs included in our meta-analysis, three AEs (dizziness, fatigue, and back pain) were found to be significantly associated with BRV treatment. But we did not find that the risk of them was obviously increasing with the increasing doses. CONCLUSION: This meta-analysis showed that BRV treatment was reasonably tolerated by patients and rarely caused serious AEs. Further clinical studies will be needed to more concretely determine the safety and tolerability profile of BRV. CI - Copyright (c) 2016 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved. FAU - Zhu, Li-Na AU - Zhu LN AD - Department of Neurology, West China Hospital, Sichuan University, Wai Nan Guo Xue Lane 37#, Chengdu 610041, Sichuan, China. Electronic address: Angelinazhuzhu@163.com. FAU - Chen, Deng AU - Chen D AD - Department of Neurology, West China Hospital, Sichuan University, Wai Nan Guo Xue Lane 37#, Chengdu 610041, Sichuan, China. Electronic address: jerry.k.d@163.com. FAU - Chen, Tao AU - Chen T AD - Department of Neurology, West China Hospital, Sichuan University, Wai Nan Guo Xue Lane 37#, Chengdu 610041, Sichuan, China. Electronic address: 417358610@qq.com. FAU - Xu, Da AU - Xu D AD - Department of Neurology, West China Hospital, Sichuan University, Wai Nan Guo Xue Lane 37#, Chengdu 610041, Sichuan, China. Electronic address: 498688793@qq.com. FAU - Chen, Si-Han AU - Chen SH AD - Department of Neurology, West China Hospital, Sichuan University, Wai Nan Guo Xue Lane 37#, Chengdu 610041, Sichuan, China. Electronic address: 13608223283@163.com. FAU - Liu, Ling AU - Liu L AD - Department of Neurology, West China Hospital, Sichuan University, Wai Nan Guo Xue Lane 37#, Chengdu 610041, Sichuan, China. Electronic address: zjllxx1968@163.com. LA - eng PT - Journal Article PT - Meta-Analysis DEP - 20161114 PL - England TA - Seizure JT - Seizure JID - 9306979 RN - 0 (Anticonvulsants) RN - 0 (Pyrrolidinones) RN - U863JGG2IA (brivaracetam) SB - IM MH - Anticonvulsants/*adverse effects MH - Databases, Bibliographic/statistics & numerical data MH - Epilepsy/*drug therapy MH - Female MH - Humans MH - Male MH - Mental Disorders/*chemically induced MH - Pyrrolidinones/*adverse effects MH - *Randomized Controlled Trials as Topic OTO - NOTNLM OT - Adverse effects OT - Antiepileptic drug OT - Brivaracetam EDAT- 2016/11/30 06:00 MHDA- 2017/03/14 06:00 CRDT- 2016/11/30 06:00 PHST- 2016/07/21 00:00 [received] PHST- 2016/09/26 00:00 [revised] PHST- 2016/11/08 00:00 [accepted] PHST- 2016/11/30 06:00 [pubmed] PHST- 2017/03/14 06:00 [medline] PHST- 2016/11/30 06:00 [entrez] AID - S1059-1311(16)30214-X [pii] AID - 10.1016/j.seizure.2016.11.008 [doi] PST - ppublish SO - Seizure. 2017 Feb;45:7-16. doi: 10.1016/j.seizure.2016.11.008. Epub 2016 Nov 14.