• Intensive care medicine · May 2022

    Randomized Controlled Trial Multicenter Study

    Long-term outcomes of dexamethasone 12 mg versus 6 mg in patients with COVID-19 and severe hypoxaemia.

    • Anders Granholm, Maj-Brit Nørregaard Kjær, Marie Warrer Munch, Sheila Nainan Myatra, VijayaraghavanBharath Kumar TirupakuzhiBKTDepartment of Critical Care, Apollo Hospitals, Chennai, India.Chennai Critical Care Consultants, Chennai, India.The George Institute for Global Health, New Delhi, India., Maria Cronhjort, WahlinRebecka RubensonRRDepartment of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden., Stephan M Jakob, Luca Cioccari, Gitte Kingo Vesterlund, Tine Sylvest Meyhoff, Marie Helleberg, MøllerMorten HylanderMHDepartment of Intensive Care 4131, Copenhagen University Hospital-Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark.Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark., Thomas Benfield, Balasubramanian Venkatesh, Naomi E Hammond, Sharon Micallef, Abhinav Bassi, Oommen John, Vivekanand Jha, Klaus Tjelle Kristiansen, Charlotte Suppli Ulrik, JørgensenVibeke LindVLDepartment of Thoracic Anaesthesiology, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark., Margit Smitt, Morten H Bestle, Anne Sofie Andreasen, Lone Musaeus Poulsen, Bodil Steen Rasmussen, Anne Craveiro Brøchner, Thomas Strøm, Anders Møller, Mohd Saif Khan, Ajay Padmanaban, Jigeeshu Vasishtha Divatia, Sanjith Saseedharan, Kapil Borawake, Farhad Kapadia, Subhal Dixit, Rajesh Chawla, Urvi Shukla, Pravin Amin, Michelle S Chew, Christian Aage Wamberg, Neeta Bose, Mehul S Shah, Iben S Darfelt, Christian Gluud, Theis Lange, and Anders Perner.
    • Department of Intensive Care 4131, Copenhagen University Hospital-Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark.
    • Intensive Care Med. 2022 May 1; 48 (5): 580589580-589.

    PurposeWe assessed long-term outcomes of dexamethasone 12 mg versus 6 mg given daily for up to 10 days in patients with coronavirus disease 2019 (COVID-19) and severe hypoxaemia.MethodsWe assessed 180-day mortality and health-related quality of life (HRQoL) using EuroQoL (EQ)-5D-5L index values and EQ visual analogue scale (VAS) in the international, stratified, blinded COVID STEROID 2 trial, which randomised 1000 adults with confirmed COVID-19 receiving at least 10 L/min of oxygen or mechanical ventilation in 26 hospitals in Europe and India. In the HRQoL analyses, higher values indicated better outcomes, and deceased patients were given a score of zero.ResultsWe obtained vital status at 180 days for 963 of 982 patients (98.1%) in the intention-to-treat population, EQ-5D-5L index value data for 922 (93.9%) and EQ VAS data for 924 (94.1%). At 180 days, 164 of 486 patients (33.7%) had died in the 12 mg group versus 184 of 477 (38.6%) in the 6 mg group [adjusted risk difference - 4.3%; 99% confidence interval (CI) - 11.7-3.0; relative risk 0.89; 0.72-1.09; P = 0.13]. The adjusted mean differences between the 12 mg and the 6 mg groups in EQ-5D-5L index values were 0.06 (99% CI - 0.01 to 0.12; P = 0.10) and in EQ VAS scores 4 (- 3 to 10; P = 0.22).ConclusionAmong patients with COVID-19 and severe hypoxaemia, dexamethasone 12 mg compared with 6 mg did not result in statistically significant improvements in mortality or HRQoL at 180 days, but the results were most compatible with benefit from the higher dose.© 2022. Springer-Verlag GmbH Germany, part of Springer Nature.

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