PMID- 32511539 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20240211 DP - 2020 May 8 TI - Assessment of Hydroxychloroquine and Chloroquine Safety Profiles: A Systematic Review and Meta-Analysis. LID - 2020.05.02.20088872 [pii] LID - 10.1101/2020.05.02.20088872 [doi] AB - BACKGROUND: Recently, chloroquine (CQ) and its derivative hydroxychloroquine (HCQ) have 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 PubMed, MEDLINE, Cochrane, the Cochrane Central Register of Controlled Trials (CENTRAL), EMBASE, and the ClinicalTrials.gov for all the RCTs comparing CQ or HCQ with placebo or other active agents, published before March 31, 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 17 studies for CQ and HCQ, respectively, that satisfied our inclusion criteria. Of these studies, we performed meta-analysis on the ones that were placebo-controlled, which included 6 studies for CQ and 14 studies for HCQ. We did not limit our analysis to published reports 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 1,096 participants (n=558 HCQ and n=538 placebo). The overall mild or total AEs were statistically higher comparing CQ or HCQ to placebo. The AEs were further categorized into four groups and analyses revealed that neurologic, gastrointestinal, dermatologic, and ophthalmic AEs were higher in participants taking CQ compared to placebo. Although this was not evident in HCQ treated groups, further analyses suggested that there were more AEs attributed to other organ system that were not included in the categorized meta-analyses. Additionally, meta-regression analyses revealed that total AEs was affected by dosage for the CQ group. CONCLUSIONS: Taken together, we found that participants taking either CQ or HCQ have more AEs than participants taking placebo. Precautionary measures should be taken when using these drugs to treat COVID-19. FAU - Ren, Lu AU - Ren L AD - Department of Internal Medicine, Cardiology, UC Davis. FAU - Xu, Wilson AU - Xu W AD - Department of Internal Medicine, Cardiology, UC Davis. FAU - Overton, James L AU - Overton JL AD - Department of Internal Medicine, Cardiology, UC Davis. FAU - Yu, Shandong AU - Yu S AD - Department of Cardiology, Cardiovascular Center, Beijing Friendship Hospital, Capital Medical University, Beijing. FAU - Chiamvimonvat, Nipavan AU - Chiamvimonvat N AD - Department of Internal Medicine, Cardiology, UC Davis. AD - Department of Veteran Affairs. FAU - Thai, Phung N AU - Thai PN AD - Department of Internal Medicine, Cardiology, UC Davis. 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 - Preprint DEP - 20200508 PL - United States TA - medRxiv JT - medRxiv : the preprint server for health sciences JID - 101767986 UIN - Front Pharmacol. 2020 Oct 14;11:562777. PMID: 33154723 PMC - PMC7274215 EDAT- 2020/06/09 06:00 MHDA- 2020/06/09 06:01 PMCR- 2020/06/05 CRDT- 2020/06/09 06:00 PHST- 2020/06/09 06:00 [entrez] PHST- 2020/06/09 06:00 [pubmed] PHST- 2020/06/09 06:01 [medline] PHST- 2020/06/05 00:00 [pmc-release] AID - 2020.05.02.20088872 [pii] AID - 10.1101/2020.05.02.20088872 [doi] PST - epublish SO - medRxiv [Preprint]. 2020 May 8:2020.05.02.20088872. doi: 10.1101/2020.05.02.20088872.