Prolonged higher dose methylprednisoloneversusconventional dexamethasone in COVID-19 pneumonia: a randomised controlled trial (MEDEAS)

Medientyp: E-Artikel
Titel: Prolonged higher dose methylprednisoloneversusconventional dexamethasone in COVID-19 pneumonia: a randomised controlled trial (MEDEAS)
Beteiligte: Salton, Francesco; Confalonieri, Paola; Centanni, Stefano; Mondoni, Michele; Petrosillo, Nicola; Bonfanti, Paolo; Lapadula, Giuseppe; Lacedonia, Donato; Voza, Antonio; Carpenè, Nicoletta; Montico, Marcella; Reccardini, Nicolò; Meduri, Gianfranco Umberto; Ruaro, Barbara; Confalonieri, Marco; Citton, Gloria Maria; Lapadula, Giulia; Bozzi, Chiara; Tavano, Stefano; Pozzan, Riccardo; Andrisano, Alessia Giovanna; Jaber, Mohamad; Mari, Marco; Trotta, Liliana; [...]
Erschienen: European Respiratory Society (ERS), 2023
Erschienen in: European Respiratory Journal
Sprache: Englisch
DOI: 10.1183/13993003.01514-2022
ISSN: 0903-1936; 1399-3003
Schlagwörter: Pulmonary and Respiratory Medicine
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Beschreibung: <jats:sec><jats:title>Background</jats:title><jats:p>Dysregulated systemic inflammation is the primary driver of mortality in severe coronavirus disease 2019 (COVID-19) pneumonia. Current guidelines favour a 7–10-day course of any glucocorticoid equivalent to dexamethasone 6 mg daily. A comparative randomised controlled trial (RCT) with a higher dose and a longer duration of intervention was lacking.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>We conducted a multicentre, open-label RCT to investigate methylprednisolone 80 mg as a continuous daily infusion for 8 days followed by slow tapering<jats:italic>versus</jats:italic>dexamethasone 6 mg once daily for up to 10 days in adult patients with COVID-19 pneumonia requiring oxygen or noninvasive respiratory support. The primary outcome was reduction in 28-day mortality. Secondary outcomes were mechanical ventilation-free days at 28 days, need for intensive care unit (ICU) referral, length of hospitalisation, need for tracheostomy, and changes in C-reactive protein (CRP) levels, arterial oxygen tension/inspiratory oxygen fraction (<jats:italic>P</jats:italic><jats:sub>aO<jats:sub>2</jats:sub></jats:sub>/<jats:italic>F</jats:italic><jats:sub>IO<jats:sub>2</jats:sub></jats:sub>) ratio and World Health Organization Clinical Progression Scale at days 3, 7 and 14.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>677 randomised patients were included. Findings are reported as methylprednisolone (n=337)<jats:italic>versus</jats:italic>dexamethasone (n=340). By day 28, there were no significant differences in mortality (35 (10.4%)<jats:italic>versus</jats:italic>41 (12.1%); p=0.49) nor in median mechanical ventilation-free days (median (interquartile range (IQR)) 23 (14)<jats:italic>versus</jats:italic>24 (16) days; p=0.49). ICU referral was necessary in 41 (12.2%)<jats:italic>versus</jats:italic>45 (13.2%) (p=0.68) and tracheostomy in 8 (2.4%)<jats:italic>versus</jats:italic>9 (2.6%) (p=0.82). Survivors in the methylprednisolone group required a longer median (IQR) hospitalisation (15 (11)<jats:italic>versus</jats:italic>14 (11) days; p=0.005) and experienced an improvement in CRP levels, but not in<jats:italic>P</jats:italic><jats:sub>aO<jats:sub>2</jats:sub></jats:sub>/<jats:italic>F</jats:italic><jats:sub>IO<jats:sub>2</jats:sub></jats:sub>ratio, at days 7 and 14. There were no differences in disease progression at the prespecified time-points.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>Prolonged, higher dose methylprednisolone did not reduce mortality at 28 days compared with conventional dexamethasone in COVID-19 pneumonia.</jats:p></jats:sec>

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