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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
Author(s) -
CorralGudino Luis,
Cusacovich Ivan,
MartínGonzález Jose Ignacio,
MuelaMolinero Alberto,
AbadíaOtero Jésica,
GonzálezFuentes Roberto,
RuízdeTemiño Ángela,
TapiaMoral Elena,
CuadradoMedina Francisca,
MartínAsenjo Miguel,
MiramontesGonzález Pablo,
DelgadoGonzález Jose Luis,
Ines Sandra,
AbadManteca Laura,
UsateguiMartín Iciar,
RuizAlbi Tomás,
MirandaRiaño Sara,
RodríguezFortúnez Patricia,
RodríguezJiménez Consuelo,
LópezFranco Esperanza,
Marcos Miguel
Publication year - 2023
Publication title -
european journal of clinical investigation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.164
H-Index - 107
eISSN - 1365-2362
pISSN - 0014-2972
DOI - 10.1111/eci.13881
Subject(s) - methylprednisolone , medicine , dexamethasone , randomized controlled trial , interim analysis , pneumonia , anesthesia , fraction of inspired oxygen , intensive care unit , observational study , bolus (digestion) , mechanical ventilation
Abstract 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.