Cardiac adverse events associated with chloroquine and hydroxychloroquine exposure in 20 years of drug safety surveillance reports
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Abstract
Chloroquine (CQ) and hydroxychloroquine (HCQ) are on the World Health Organization’s List of Essential Medications for treating non-resistant malaria, rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). In addition, both drugs are currently used off-label in hospitals worldwide and in numerous clinical trials for the treatment of SARS-CoV-2 infection. However, CQ and HCQ use has been associated with cardiac side effects, which is of concern due to the higher risk of COVID-19 complications in patients with heart related disorders, and increased mortality associated with COVID-19 cardiac complications. In this study we analyzed over thirteen million adverse event reports form the United States Food and Drug Administration Adverse Event Reporting System to confirm and quantify the association of cardiac side effects of CQ and HCQ. Additionally, we identified several confounding factors, including male sex, NSAID coadministration, advanced age, and prior diagnoses contributing to drug related cardiotoxicity. These findings may help guide therapeutic decision making and ethical trial design for COVID-19 treatment.
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SciScore for 10.1101/2020.05.19.20107227: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
NIH rigor criteria are not applicable to paper type.Table 2: Resources
No key resources detected.
Results from OddPub: Thank you for sharing your code.
Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT0431589610 Trial number did not resolve on clinicaltrials.gov. Is the number correct? NA NCT0431801511 Trial number did not resolve on clinicaltrials.gov. Is the number correct? NA NCT0431844412 Trial number did not resolve on clinicaltrials.gov. Is the number … SciScore for 10.1101/2020.05.19.20107227: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
NIH rigor criteria are not applicable to paper type.Table 2: Resources
No key resources detected.
Results from OddPub: Thank you for sharing your code.
Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT0431589610 Trial number did not resolve on clinicaltrials.gov. Is the number correct? NA NCT0431801511 Trial number did not resolve on clinicaltrials.gov. Is the number correct? NA NCT0431844412 Trial number did not resolve on clinicaltrials.gov. Is the number correct? NA NCT0432127813 Trial number did not resolve on clinicaltrials.gov. Is the number correct? NA NCT0430866814 Trial number did not resolve on clinicaltrials.gov. Is the number correct? NA NCT0430405315 Trial number did not resolve on clinicaltrials.gov. Is the number correct? NA NCT0431637716 Trial number did not resolve on clinicaltrials.gov. Is the number correct? NA NCT0430329917 Trial number did not resolve on clinicaltrials.gov. Is the number correct? NA Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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