PMID- 32645478
OWN - NLM
STAT- MEDLINE
DCOM- 20200924
LR  - 20221207
IS  - 1873-0442 (Electronic)
IS  - 1477-8939 (Print)
IS  - 1477-8939 (Linking)
VI  - 36
DP  - 2020 Jul-Aug
TI  - Hydroxychloroquine safety: A meta-analysis of randomized controlled trials.
PG  - 101812
LID - S1477-8939(20)30308-2 [pii]
LID - 10.1016/j.tmaid.2020.101812 [doi]
AB  - BACKGROUND: Hydroxychloroquine (HCQ) is currently being examined for COVID-19. No 
      previous meta-analysis has evaluated its side effects versus placebo. We 
      conducted this meta-analysis to compare the safety of HCQ versus placebo. 
      METHODS: Two authors independently searched PubMed and EMBASE databases for 
      randomized controlled trials (RCTs) of adults comparing the adverse events (AEs) 
      of HCQ versus placebo for any indication. Peto odds ratios (Peto ORs) and 95% 
      confidence intervals (CIs) were calculated based on random-effects models. The 
      heterogeneity (I(2)) was assessed using Cochran's Q test. RESULTS: Nine RCTs 
      (eight were double-blind) with a total of 916 patients were included. HCQ caused 
      significantly more skin pigmentation than placebo (Peto OR, 4.64; 95% CI, 1.13 to 
      19.00; P-value = 0.033; I(2) = 0%). The increase in other AEs did not reach 
      statistical significance: rash (Peto OR, 1.11; 95% CI, 0.3 to 3.77; 
      P-value = 0.03; I(2) = 0%); gastrointestinal AEs (Peto OR, 1.43; 95% CI, 0.55 to 
      3.72; P-value = 0.46; I(2) = 15.17%); headache (Peto OR, 1.94; 95% CI, 0.65 to 
      5.78; P-value = 0.23; I(2) = 9.99%); dizziness (Peto OR, 1.32; 95% CI, 0.49 to 
      3.52; P-value = 0.58; I(2) = 0%); fatigue (Peto OR, 2.13; 95% CI, 0.76 to 5.98; 
      P-value = 0.15; I(2) = 0%); and visual AEs (Peto OR, 1.61; 95% CI, 0.76 to 3.41; 
      P-value = 0.22; I(2) = 0%). Cardiac toxicity was not reported. CONCLUSIONS: This 
      meta-analysis of RCTs found a significantly higher risk of skin pigmentation in 
      HCQ users versus placebo. More data are needed to evaluate HCQ in the context of 
      COVID-19 treatment.
CI  - Copyright (c) 2020 Elsevier Ltd. All rights reserved.
FAU - Eljaaly, Khalid
AU  - Eljaaly K
AD  - Faculty of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia; College of 
      Pharmacy, University of Arizona, Tucson, AZ, USA. Electronic address: 
      khalid-eljaaly@live.com.
FAU - Alireza, Kasim Huseein
AU  - Alireza KH
AD  - Faculty of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia.
FAU - Alshehri, Samah
AU  - Alshehri S
AD  - Faculty of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia; College of 
      Pharmacy, University of Arizona, Tucson, AZ, USA.
FAU - Al-Tawfiq, Jaffar A
AU  - Al-Tawfiq JA
AD  - Infectious Disease Unit, Specialty Internal Medicine, Johns Hopkins Aramco 
      Healthcare, Dhahran, Saudi Arabia; Department of Medicine, Indiana University 
      School of Medicine, Indianapolis, IN, USA; Department of Medicine, Johns Hopkins 
      University School of Medicine, Baltimore, MD, USA.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, Non-U.S. Gov't
DEP - 20200706
PL  - Netherlands
TA  - Travel Med Infect Dis
JT  - Travel medicine and infectious disease
JID - 101230758
RN  - 0 (Antirheumatic Agents)
RN  - 4QWG6N8QKH (Hydroxychloroquine)
SB  - IM
MH  - Alzheimer Disease/*drug therapy
MH  - Antirheumatic Agents/*adverse effects
MH  - Arthritis, Rheumatoid/drug therapy
MH  - Asymptomatic Infections
MH  - Betacoronavirus
MH  - COVID-19
MH  - Chronic Urticaria/*drug therapy
MH  - Coronavirus Infections/drug therapy
MH  - Dizziness/chemically induced
MH  - Exanthema/chemically induced
MH  - Fatigue/chemically induced
MH  - Gastrointestinal Diseases/chemically induced
MH  - Glomerulonephritis, IGA/*drug therapy
MH  - HIV Infections/*drug therapy
MH  - Headache/chemically induced
MH  - Humans
MH  - Hydroxychloroquine/*adverse effects
MH  - Hyperpigmentation/*chemically induced
MH  - Lupus Erythematosus, Cutaneous/drug therapy
MH  - Lupus Erythematosus, Systemic/drug therapy
MH  - Osteoarthritis/drug therapy
MH  - Pandemics
MH  - Pneumonia, Viral/drug therapy
MH  - Randomized Controlled Trials as Topic
MH  - Rheumatic Diseases/*drug therapy
MH  - SARS-CoV-2
MH  - COVID-19 Drug Treatment
PMC - PMC7342171
OTO - NOTNLM
OT  - Adverse reaction
OT  - COVID-19
OT  - Chloroquine
OT  - Hydroxychloroquine
OT  - Hyperpigmentation
OT  - Systematic review
EDAT- 2020/07/10 06:00
MHDA- 2020/09/25 06:00
PMCR- 2020/07/06
CRDT- 2020/07/10 06:00
PHST- 2020/05/19 00:00 [received]
PHST- 2020/06/15 00:00 [revised]
PHST- 2020/06/25 00:00 [accepted]
PHST- 2020/07/10 06:00 [pubmed]
PHST- 2020/09/25 06:00 [medline]
PHST- 2020/07/10 06:00 [entrez]
PHST- 2020/07/06 00:00 [pmc-release]
AID - S1477-8939(20)30308-2 [pii]
AID - 101812 [pii]
AID - 10.1016/j.tmaid.2020.101812 [doi]
PST - ppublish
SO  - Travel Med Infect Dis. 2020 Jul-Aug;36:101812. doi: 10.1016/j.tmaid.2020.101812. 
      Epub 2020 Jul 6.