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Hydroxychloroquine safety: A meta-analysis of randomized controlled trials
Khalid Eljaaly1, Kasim Huseein Alireza2, Samah Alshehri1
1Faculty of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia; College of Pharmacy, University of Arizona, Tucson, AZ, USA.
Travel Medicine and Infectious Disease
|July 10, 2020
Summary
Hydroxychloroquine (HCQ) use was linked to a higher risk of skin pigmentation compared to placebo. Further research is needed to assess HCQ
Area of Science:
- Pharmacovigilance
- Evidence Synthesis
- Clinical Trial Analysis
Background:
- Hydroxychloroquine (HCQ) is under investigation for COVID-19 treatment.
- No prior meta-analysis has specifically evaluated HCQ's side effects against a placebo.
- This study addresses the need for a comprehensive safety comparison.
Purpose of the Study:
- To conduct a meta-analysis comparing the safety profile of hydroxychloroquine (HCQ) versus placebo.
- To identify and quantify adverse events associated with HCQ use in randomized controlled trials (RCTs).
Main Methods:
- Systematic literature search of PubMed and EMBASE for RCTs comparing HCQ and placebo in adults.
- Independent data extraction and analysis by two authors.
- Calculation of Peto odds ratios (ORs) and 95% confidence intervals (CIs) using random-effects models; heterogeneity assessed via Cochran's Q test.
Main Results:
- Nine RCTs (n=916) were included; eight were double-blind.
- Significantly higher incidence of skin pigmentation with HCQ versus placebo (Peto OR, 4.64; 95% CI, 1.13-19.00; P=0.033).
- No statistically significant increases in other adverse events, including rash, gastrointestinal issues, headache, dizziness, fatigue, or visual disturbances.
Conclusions:
- Hydroxychloroquine (HCQ) use is associated with a significantly increased risk of skin pigmentation when compared to placebo.
- The study did not find statistically significant evidence for increased risk of other common adverse events.
- Additional research is warranted to fully understand HCQ's safety and efficacy for COVID-19 treatment.
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