Previously submitted to: JMIR Public Health and Surveillance (no longer under consideration since Mar 01, 2024)
Date Submitted: May 3, 2023
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Efficacy and Safety Outcomes of High-Dose Corticosteroid Use in Severe to Critically Ill Patients With COVID-19: A Nationwide Population-Based Study
ABSTRACT
Background:
Systemic corticosteroids have become the standard of care for severe to critically ill patients with coronavirus disease 2019 (COVID-19). However, the real-world efficacy and safety outcomes associated with a higher dose of corticosteroids remain uncertain.
Objective:
We aimed to identify the real-world efficacy and safety outcomes associated with a higher dose of corticosteroids for severe to critically ill patients with COVID-19.
Methods:
We conducted a nationwide, population-based, matched cohort study of severe to critically ill adult patients with COVID-19 between January 2020 and June 2021 in Korea using the National Health Information Database. Patients using systemic corticosteroids were included, and high-dose corticosteroid use was defined as a daily mean prescribed dose of more than 6 mg of dexamethasone. Overall mortality and risk of COVID-19-associated pulmonary aspergillosis (CAPA) according to corticosteroid dose were examined.
Results:
During the study period, 102,304 patients were screened, 5,754 met the eligibility criteria, and 2,138 were successfully matched. The mean prescribed daily dose was 4.2 mg and 13.4 mg in the standard- and high-dose groups, respectively, and the mean duration of use was not different between the groups. High-dose corticosteroid use increased all-cause mortality at 28 days (adjusted hazard ratio [aHR], 1.48; 95% confidence interval [CI], 1.25–1.76) and 90 days (aHR, 1.63; CI, 1.44-1.85) after admission. Subgroup analysis revealed a statistically significant elevation in the risk of mortality among patients who exclusively relied on either a low-flow or high-flow nasal cannula, with aHR of 1.41 (95% CI: 1.10-1.81) and 1.46 (95% CI: 1.09-1.95) respectively. No significant impact of high-dose steroids was observed, even in patients who underwent mechanical ventilation at 28 days (aHR, 1.17; CI, 0.79-1.72). As a safety outcome, high-dose corticosteroid use showed a notable association with the development of CAPA (aHR, 2.97; 95% CI, 0.94–9.43).
Conclusions:
Among severe to critically ill patients with COVID-19, high-dose corticosteroid use resulted in increased 28-day all-cause mortality and also showed a strong association with the development of CAPA.
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