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.
【저자키워드】 public health, viral infection, Infectious diseases, Health care, Therapeutics, cardiovascular diseases, systemic lupus erythematosus, rheumatoid arthritis, drug therapy, adverse effects, Antimicrobial therapy, Autoimmune diseases, 【초록키워드】 COVID-19, Treatment, clinical trial, Trial, Hydroxychloroquine, SARS-COV-2 infection, hospital, drug, malaria, therapeutic, adverse event, Patient, Reporting, HCQ, Side effects, diagnose, association, food, Male sex, Cardiac complications, SLE, Side effect, Adverse, higher risk, disorders, advanced age, help, increased mortality, list, confounding factors, off-label, System, analyzed, the United State, addition, contributing to, COVID-19 complication, Essential, with COVID-19, World Health Organization’, 【제목키워드】 Chloroquine, Hydroxychloroquine, Surveillance, adverse event, cardiac,