JAMA study reveals use of dexamethasone and others in non-hospitalized patients with mild to moderate illness.
Use of hydroxychloroquine and ivermectin to treat COVID-19, despite a lack of scientific evidence, remains “a thing.”
Now, there is evidence clinicians across the United States are using other drugs incorrectly to treat infections caused by SARS-CoV-2. In an analysis of data from Medicare and the US Food and Drug Administration’s (FDA) Sentinel System, published on April 8 by JAMA, large numbers of non-hospitalized virus patients nationally are being prescribed systemic corticosteroids, despite National Institutes of Health (NIH) guidance to the contrary.
“Despite NIH recommendations advising against systemic corticosteroid use in patients with mild to moderate COVID-19, non-hospitalized COVID-19 patients have been increasingly prescribed systemic corticosteroids, often on the day of diagnosis,” the researchers, from the FDA’s Center for Drug Evaluation and Research, told Contagion through an agency spokesperson.
“We cannot rule out the possibility that the results of the UK RECOVERY trial… might have influenced the use of [these drugs],” they said.
Indeed, the RECOVERY showed that use of the corticosteroid dexamethasone lowered 28-day mortality in COVID-19 hospitalized patients receiving either invasive mechanical ventilation or oxygen alone. However, research to date has not supported the use of corticosteroids in outpatient settings, or in mild to moderate disease.
In the JAMA study, among 576,885 Medicare and 766,105 Sentinel-enrolled COVID-19 patients, 16.4% and 9.4%, respectively, received systemic corticosteroids in an outpatient setting within 14 days of COVID-19 diagnosis. Corticosteroid in these patients use increased from 2.2% in April 2020 to 21.1% in August 2021 among the Medicare patients and from 2.2% in April 2020 to 13.8% in July 2021 among the Sentinel patients, according to the researchers.
This roughly coincides with the release of early data from the RECOVERY trial.
The most-used corticosteroids in the analysis were dexamethasone in Medicare (43.8%) and prednisone in Sentinel (34.1%) patients, with internal medicine or family/general practitioners and emergency medicine specialists the leading prescribers. Treatment often started on the day of COVID-19 diagnosis in up to 60% of cases, the researchers said, with up to 80% occurring following “pharmacy dispensings” rather than “medical encounters,” they said.
Azithromycin was the most common concomitant therapy (in more than 45% of cases), and it was often initiated on the same date as the corticosteroid, followed by monoclonal antibodies, inhaled corticosteroids, ivermectin, and nonoral anticoagulants. Azithromycin has been associated with severe cardiovascular adverse events in people infected with SARS-CoV-2 in earlier studies.
“To date, there is a lack of efficacy data on the use of systemic corticosteroids in patients with mild to moderate COVID-19,” the authors of the JAMA study told Contagion. “Given the increasing use of systemic corticosteroids, the potential safety signal, and lack of efficacy data in these patients, it is critical that prescribers consider the NIH guidelines in the therapeutic management of non-hospitalized patients with COVID-19.”