Abstract
Introduction: In late 2019, a new coronavirus-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-was discovered in Wuhan, China, and the World Health Organization later declared coronavirus disease 2019 (COVID-19) a pandemic. Numerous drugs have been repurposed and investigated for therapeutic effectiveness in the disease, including those from “Solidarity,” an international clinical trial (azithromycin, chloroquine, hydroxychloroquine, the fixed combination lopinavir/ritonavir, and remdesivir).
Objective: Our objective was to evaluate adverse drug reaction (ADR) reporting for drugs when used in the treatment of COVID-19 compared with use for other indications, specifically focussing on sex differences.
Method: We extracted reports on COVID-19-specific treatments from the global ADR database, VigiBase, using an algorithm developed to identify reports that listed COVID-19 as the indication. The Solidarity trial drugs were included, as were any drugs reported ≥ 100 times. We performed a descriptive comparison of reports for the same drugs used in non-COVID-19 indications. The data lock point date was 7 June 2020.
Results: In total, 2573 reports were identified for drugs used in the treatment of COVID-19. In order of frequency, the most reported ADRs were electrocardiogram QT-prolonged, diarrhoea, nausea, hepatitis, and vomiting in males and diarrhoea, electrocardiogram QT-prolonged, nausea, vomiting, and upper abdominal pain in females. Other hepatic and kidney-related events were included in the top ten ADRs in males, whereas no hepatic or renal terms were reported for females. COVID-19-related reporting patterns differed from non-pandemic reporting for these drugs.
Conclusion: Review of a global database of suspected ADR reports revealed sex differences in the reporting patterns for drugs used in the treatment of COVID-19. Patterns of ADR sex differences need further elucidation.
【초록키워드】 COVID-19, Treatment, coronavirus disease, review, Coronavirus disease 2019, coronavirus, clinical trial, pandemic, Chloroquine, Lopinavir/ritonavir, Azithromycin, Trial, Hydroxychloroquine, Lopinavir, Ritonavir, drugs, Remdesivir, Sex, drug, abdominal pain, database, electrocardiogram, Hepatitis, International, Algorithm, Wuhan, therapeutic, male, Effectiveness, respiratory, drug reaction, pattern, Sex difference, Other, ADRS, Adverse drug reaction, Combination, Frequency, remdesivir), Health Organization, diarrhoea, (azithromycin, World Health Organization, Non-COVID-19, acute respiratory syndrome, treatment of COVID-19, acute respiratory syndrome coronavirus, indication, indications, nausea, vomiting, renal, solidarity, females, event, males, COVID-19-specific treatments, Wuhan, China, identify, performed, evaluate, reported, investigated, the disease, fixed, Numerous, ADR, COVID-19-specific treatment, 【제목키워드】 COVID-19, Safety, drug, Adverse, reaction, individual, report, difference,