Journal
EUROPEAN JOURNAL OF CLINICAL INVESTIGATION
Volume 53, Issue 1, Pages -Publisher
WILEY
DOI: 10.1111/eci.13881
Keywords
COVID-19; dexamethasone; intubation; intratracheal; methylprednisolone; mortality
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This study compared the effectiveness of methylprednisolone 250 mg/d for 3 days with dexamethasone 6 mg/d for 10 days in severe COVID-19 patients. The results showed that there was no significant difference in mortality or intubation between methylprednisolone and dexamethasone, and hyperglycemia was more common in the methylprednisolone group.
Background The efficacy and safety of high versus medium doses of glucocorticoids for the treatment of patients with COVID-19 has shown mixed outcomes in controlled trials and observational studies. We aimed to evaluate the effectiveness of methylprednisolone 250 mg bolus versus dexamethasone 6 mg in patients with severe COVID-19. Methods A randomised, open-label, controlled trial was conducted between February and August 2021 at four hospitals in Spain. The trial was suspended after the first interim analysis since the investigators considered that continuing the trial would be futile. Patients were randomly assigned in a 1:1 ratio to receive dexamethasone 6 mg once daily for up to 10 days or methylprednisolone 250 mg once daily for 3 days. Results Of the 128 randomised patients, 125 were analysed (mean age 60 +/- 17 years; 82 males [66%]). Mortality at 28 days was 4.8% in the 250 mg methylprednisolone group versus 4.8% in the 6 mg dexamethasone group (absolute risk difference, 0.1% [95% CI, -8.8 to 9.1%]; p = 0.98). None of the secondary outcomes (admission to the intensive care unit, non-invasive respiratory or high-flow oxygen support, additional immunosuppressive drugs, or length of stay), or prespecified sensitivity analyses were statistically significant. Hyperglycaemia was more frequent in the methylprednisolone group at 27.0 versus 8.1% (absolute risk difference, -18.9% [95% CI, -31.8 to - 5.6%]; p = 0.007). Conclusions Among severe but not critical patients with COVID-19, 250 mg/d for 3 days of methylprednisolone compared with 6 mg/d for 10 days of dexamethasone did not result in a decrease in mortality or intubation.
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