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, Bharath Kumar Tirupakuzhi Vijayaraghavan, Maria Cronhjort, Rebecka Rubenson Wahlin, Stephan M. Jakob, Luca Cioccari, Gitte Kingo Vesterlund, Tine Sylvest Meyhoff, Marie Helleberg, Morten Hylander Møller, Thomas Benfield, Balasubramanian Venkatesh, Naomi E. Hammond, Sharon Micallef, Abhinav Bassi, Oommen John, Vivekanand JhaKlaus Tjelle Kristiansen, Charlotte Suppli Ulrik, Vibeke Lind Jørgensen, 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, Anders Perner*

*Kontaktforfatter

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Abstract

Purpose: We 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. Methods: We 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. Results: We 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). Conclusion: Among 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.

OriginalsprogEngelsk
TidsskriftIntensive Care Medicine
Vol/bind48
Udgave nummer5
Sider (fra-til)580-589
ISSN0342-4642
DOI
StatusUdgivet - maj 2022

Bibliografisk note

Funding Information:
The Novo Nordisk Foundation and the Research Council of Rigshospitalet, Grant nos [0062998, E-22703-06]. The funders had no role in the design, conduct, analyses or reporting of the trial.

Funding Information:
AG, MBNK, MWM, GKV, TSM, MHM and AP are affiliated with the Dept. of Intensive Care, Rigshospitalet, which has received grants for research from Pfizer, Fresenius Kabi, AM Pharma, and Sygeforsikringen ‘danmark’ outside the submitted work. MH has participated in advisory boards for AstraZeneca, GSK, Gilead, MSD, Roche and Sobi and received speaker’s honoraria from GSK and Gilead. TB reports grants from Novo Nordisk Foundation, grants from Simonsen Foundation, grants and personal fees from GSK, grants and personal fees from Pfizer, personal fees from Astra Zeneca, personal fees from Janssen, personal fees from Boehringer Ingelheim, grants and personal fees from Gilead, personal fees from MSD, grants from Lundbeck Foundation, grants from Kai Hansen Foundation, personal fees from Pentabase ApS, grants from Erik and Susanna Olesen’s Charitable Fund, outside the submitted work. SMJ and LC are affiliated with Inselspital, Bern University Hospital, which has received grants from Edwards Lifesciences Services GmbH, Phagenesis Limited, and Nestlé outside the submitted work. JVD has received personal fees (paid to his institution) from Edwards India outside the submitted work. VJ has received grant funding from GSK, Baxter Healthcare, and Biocon and honoraria from Boehringer Ingelheim, Astra Zeneca, Baxter Healthcare, Bayer, NephroPlus and Zydus Cadilla, under the policy of all monies being paid to the organization.

Publisher Copyright:
© 2022, Springer-Verlag GmbH Germany, part of Springer Nature.

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