RT info:eu-repo/semantics/article T1 Effect of intravenous pulses of methylprednisolone 250 mg versus dexamethasone 6 mg in hospitalised adults with severe COVID ‐19 pneumonia: An open‐label randomised trial A1 Corral Gudino, Luis A1 Cusácovich Torres, Iván A1 Martín González, José Ignacio A1 Muela Molinero, Alberto A1 Abadía Otero, Jésica A1 González Fuentes, Roberto A1 Ruiz de Temiño de la Peña, Ángela A1 Tapia Moral, Elena A1 Cuadrado Medina, Francisca A1 Martín Asenjo, Miguel A1 Miramontes González, José Pablo A1 Delgado González, José Luis A1 Inés, Sandra A1 Abad Manteca, Laura A1 Usategui Martín, Iciar A1 Ruiz Albi, Tomás A1 Miranda Riaño, Sara A1 Rodríguez Fortúnez, Patricia A1 Rodríguez Jiménez, Consuelo A1 López Franco, Esperanza A1 Marcos, Miguel K1 COVID- 19 K1 Dexamethasone K1 Intubation K1 Intratracheal K1 Methylprednisolone K1 Mortality K1 32 Ciencias Médicas AB 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. PB Wiley SN 0014-2972 YR 2022 FD 2022 LK https://uvadoc.uva.es/handle/10324/57785 UL https://uvadoc.uva.es/handle/10324/57785 LA eng NO European Journal of Clinical Investigation, 2022, vol. 53, n. 1, e13881. NO Producción Científica DS UVaDOC RD 22-dic-2024