Details
In the United Kingdom Randomized Evaluation of COVID-19 Therapy (RECOVERY) trial results publicized in June 2020, dexamethasone appeared to reduce mortality in hospitalized patients with COVID-19 who received supplemental oxygen or mechanical ventilation. However, a potential signal of harm of dexamethasone use was seen in hospitalized patients with COVID-19 who did not receive respiratory support. To gain insight into how the trial results may affect inpatient corticosteroid use patterns in the U.S., the Food and Drug Administration (FDA) conducted a rapid study to assess the utilization of systemic dexamethasone and other corticosteroids among hospitalized patients with and without a COVID-19 diagnosis in the TriNetX USA Network Database, one of the FDA’s Sentinel Electronic Health Record (EHR) data sources.
Results showed that among hospitalized patients with COVID-19, the weekly proportion administered corticosteroids, dexamethasone in particular, increased substantially from the week beginning June 8, 2020 to the week beginning July 13, 2020; administration of corticosteroids remained stable among hospitalized patients without COVID-19. This analysis provided data to the FDA that may have helped inform strategies for allocating existing drug supplies to promote patient care during the COVID-19 pandemic.