PMID- 32780229 OWN - NLM STAT- MEDLINE DCOM- 20210112 LR - 20230917 IS - 1432-1041 (Electronic) IS - 0031-6970 (Print) IS - 0031-6970 (Linking) VI - 77 IP - 1 DP - 2021 Jan TI - Safety of hydroxychloroquine in COVID-19 and other diseases: a systematic review and meta-analysis of 53 randomized trials. PG - 13-24 LID - 10.1007/s00228-020-02962-5 [doi] AB - INTRODUCTION: Many concerns still exist regarding the safety of hydroxychloroquine (HCQ) in the treatment of Coronavirus Disease 2019 (COVID-19). OBJECTIVES: The purpose of this study was to evaluate the safety of HCQ in the treatment of COVID-19 and other diseases by performing a systematic review and meta-analysis. METHODS: Randomized controlled trials (RCTs) reporting the safety of HCQ in PubMed, Embase, and Cochrane Library were retrieved starting from the establishment of the database till June 5, 2020. Literature screening, data extraction, and assessment of risk bias were performed independently by two reviewers. RESULTS: We identified 53 eligible studies involving 5496 patients. The meta-analysis indicated that the risk of adverse effects (AEs) in the HCQ group was significantly increased compared with that in the control group (RD 0.05, 95%CI, 0.02 to 0.07, P = 0.0002), and the difference was also statistically significant in the COVID-19 subgroup (RD 0.15, 95%CI, 0.07 to 0.23, P = 0.0002) as well as in the subgroup for other diseases (RD 0.03, 95%CI, 0.01 to 0.04, P = 0.003). CONCLUSIONS: HCQ is associated with a high total risk of AEs compared with the placebo or no intervention in the overall population. Given the small number of COVID-19 participants included, we should be cautious regarding the conclusion stating that HCQ is linked with an increase incidence of AEs in patients with COVID-19, which we hope to confirm in the future through well-designed and larger sample size studies. FAU - Chen, Can AU - Chen C AD - Department of Pharmacy, Zhongshan Hospital, Fudan University, Shanghai, 200032, China. FAU - Pan, Kunming AU - Pan K AD - Department of Pharmacy, Zhongshan Hospital, Fudan University, Shanghai, 200032, China. FAU - Wu, Bingjie AU - Wu B AD - Department of Rheumatology, Zhongshan Hospital, Fudan University, Shanghai, 200032, China. FAU - Li, Xiaoye AU - Li X AD - Department of Pharmacy, Zhongshan Hospital, Fudan University, Shanghai, 200032, China. FAU - Chen, Zhangzhang AU - Chen Z AD - Department of Pharmacy, Zhongshan Hospital, Fudan University, Shanghai, 200032, China. FAU - Xu, Qing AU - Xu Q AD - Department of Pharmacy, Zhongshan Hospital, Fudan University, Shanghai, 200032, China. FAU - Li, Xiaoyu AU - Li X AD - Department of Pharmacy, Zhongshan Hospital, Fudan University, Shanghai, 200032, China. li.xiaoyu@zs-hospital.sh.cn. FAU - Lv, Qianzhou AU - Lv Q AUID- ORCID: 0000-0002-0866-1546 AD - Department of Pharmacy, Zhongshan Hospital, Fudan University, Shanghai, 200032, China. lv.qianzhou@zs-hospital.sh.cn. LA - eng GR - No.shslczdzk06504/Key Clinical Specialty of Shanghai (Clinical Pharmacy)/ PT - Journal Article PT - Meta-Analysis PT - Systematic Review DEP - 20200811 PL - Germany TA - Eur J Clin Pharmacol JT - European journal of clinical pharmacology JID - 1256165 RN - 4QWG6N8QKH (Hydroxychloroquine) SB - IM MH - Cardiotoxicity/etiology MH - Gastrointestinal Tract/drug effects MH - Humans MH - Hydroxychloroquine/*adverse effects MH - Outcome Assessment, Health Care MH - Publication Bias MH - *SARS-CoV-2 MH - Skin/drug effects MH - *COVID-19 Drug Treatment PMC - PMC7417776 OTO - NOTNLM OT - COVID-19 OT - Hydroxychloroquine OT - Randomized controlled trial OT - Safety OT - Systematic review COIS- The authors declare that they have no conflict of interest. EDAT- 2020/08/12 06:00 MHDA- 2021/01/13 06:00 PMCR- 2020/08/11 CRDT- 2020/08/12 06:00 PHST- 2020/04/28 00:00 [received] PHST- 2020/07/15 00:00 [accepted] PHST- 2020/08/12 06:00 [pubmed] PHST- 2021/01/13 06:00 [medline] PHST- 2020/08/12 06:00 [entrez] PHST- 2020/08/11 00:00 [pmc-release] AID - 10.1007/s00228-020-02962-5 [pii] AID - 2962 [pii] AID - 10.1007/s00228-020-02962-5 [doi] PST - ppublish SO - Eur J Clin Pharmacol. 2021 Jan;77(1):13-24. doi: 10.1007/s00228-020-02962-5. Epub 2020 Aug 11.