PMID- 33154723 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20240212 IS - 1663-9812 (Print) IS - 1663-9812 (Electronic) IS - 1663-9812 (Linking) VI - 11 DP - 2020 TI - Assessment of Chloroquine and Hydroxychloroquine Safety Profiles: A Systematic Review and Meta-Analysis. PG - 562777 LID - 10.3389/fphar.2020.562777 [doi] LID - 562777 AB - BACKGROUND: Chloroquine (CQ) and its derivative hydroxychloroquine (HCQ) have recently emerged as potential antiviral and immunomodulatory options for the treatment of 2019 coronavirus disease (COVID-19). To examine the safety profiles of these medications, we systematically evaluated the adverse events (AEs) of these medications from published randomized controlled trials (RCTs). METHODS: We systematically searched MEDLINE, the Cochrane library, the Cochrane Central Register of Controlled Trials (CENTRAL), and the ClinicalTrials.gov for all the RCTs comparing CQ or HCQ with placebo or other active agents, published before June 20, 2020. The random-effects or fixed-effects models were used to pool the risk estimates relative ratio (RR) with 95% confidence interval (CI) for the outcomes. RESULTS: The literature search yielded 23 and 19 studies for CQ and HCQ, respectively, that satisfied our inclusion criteria. Of these studies, we performed meta-analysis on 6 studies for CQ and 18 studies for HCQ. We did not limit our analysis to published records involving viral treatment alone; data also included the usage of either CQ or HCQ for the treatment of other diseases. The trials for the CQ consisted of a total of 2,137 participants (n = 1,077 CQ, n = 1,060 placebo), while the trials for HCQ involved 2,675 participants (n = 1,345 HCQ and n = 1,330 control). The overall mild and total AEs were significantly higher in CQ-treated non-COVID-19 patients, HCQ-treated non-COVID-19 patients, and HCQ-treated COVID-19 patients. The AEs were further categorized into four groups and analyses revealed that neurologic, gastrointestinal (GI), dermatologic, and sensory AEs were higher in participants taking CQ compared to placebo, while GI, dermatologic, sensory, and cardiovascular AEs were higher in HCQ-treated COVID-19 patients compared to control patients. Moreover, subgroup analysis suggested higher AEs with respect to dosage and duration in HCQ group. Data were acquired from studies with perceived low risk of bias, so plausible bias is unlikely to seriously affect the main findings of the current study. CONCLUSIONS: Taken together, we found that participants taking either CQ or HCQ exhibited more AEs than participants taking placebo or control. Precautionary measures should be taken when using these drugs to treat COVID-19. The meta-analysis was registered on OSF (https://osf.io/jm3d9). REGISTRATION: The meta-analysis was registered on OSF (https://osf.io/jm3d9). CI - Copyright (c) 2020 Ren, Xu, Overton, Yu, Chiamvimonvat and Thai. FAU - Ren, Lu AU - Ren L AD - Department of Internal Medicine, Cardiology, University of California, Davis, Davis, CA, United States. FAU - Xu, Wilson AU - Xu W AD - Department of Internal Medicine, Cardiology, University of California, Davis, Davis, CA, United States. FAU - Overton, James L AU - Overton JL AD - Department of Internal Medicine, Cardiology, University of California, Davis, Davis, CA, United States. FAU - Yu, Shandong AU - Yu S AD - Department of Cardiology, Cardiovascular Center, Beijing Friendship Hospital, Capital Medical University, Beijing, China. FAU - Chiamvimonvat, Nipavan AU - Chiamvimonvat N AD - Department of Internal Medicine, Cardiology, University of California, Davis, Davis, CA, United States. AD - Department of Veteran Affairs, Northern California Health Care System, Mather, CA, United States. FAU - Thai, Phung N AU - Thai PN AD - Department of Internal Medicine, Cardiology, University of California, Davis, Davis, CA, United States. LA - eng GR - R01 HL085727/HL/NHLBI NIH HHS/United States GR - I01 CX001490/CX/CSRD VA/United States GR - R01 HL137228/HL/NHLBI NIH HHS/United States GR - I01 BX000576/BX/BLRD VA/United States GR - R01 HL085844/HL/NHLBI NIH HHS/United States GR - F32 HL149288/HL/NHLBI NIH HHS/United States PT - Systematic Review DEP - 20201014 PL - Switzerland TA - Front Pharmacol JT - Frontiers in pharmacology JID - 101548923 UOF - medRxiv. 2020 May 08;:. PMID: 32511539 PMC - PMC7591721 OTO - NOTNLM OT - adverse events OT - chloroquine OT - hydroxychloroquine OT - meta-analysis OT - safety profiles EDAT- 2020/11/07 06:00 MHDA- 2020/11/07 06:01 PMCR- 2020/10/14 CRDT- 2020/11/06 05:59 PHST- 2020/05/16 00:00 [received] PHST- 2020/09/14 00:00 [accepted] PHST- 2020/11/06 05:59 [entrez] PHST- 2020/11/07 06:00 [pubmed] PHST- 2020/11/07 06:01 [medline] PHST- 2020/10/14 00:00 [pmc-release] AID - 10.3389/fphar.2020.562777 [doi] PST - epublish SO - Front Pharmacol. 2020 Oct 14;11:562777. doi: 10.3389/fphar.2020.562777. eCollection 2020.