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Erschienen in: Intensive Care Medicine 1/2022

10.11.2021 | COVID-19 | Original Zur Zeit gratis

Dexamethasone 12 mg versus 6 mg for patients with COVID-19 and severe hypoxaemia: a pre-planned, secondary Bayesian analysis of the COVID STEROID 2 trial

verfasst von: Anders Granholm, Marie Warrer Munch, Sheila Nainan Myatra, Bharath Kumar Tirupakuzhi Vijayaraghavan, Maria Cronhjort, Rebecka Rubenson Wahlin, Stephan M. Jakob, Luca Cioccari, Maj-Brit Nørregaard Kjær, 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 Jha, Klaus 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, Christian Gluud, Theis Lange, Anders Perner

Erschienen in: Intensive Care Medicine | Ausgabe 1/2022

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Abstract

Purpose

We compared dexamethasone 12 versus 6 mg daily for up to 10 days in patients with coronavirus disease 2019 (COVID-19) and severe hypoxaemia in the international, randomised, blinded COVID STEROID 2 trial. In the primary, conventional analyses, the predefined statistical significance thresholds were not reached. We conducted a pre-planned Bayesian analysis to facilitate probabilistic interpretation.

Methods

We analysed outcome data within 90 days in the intention-to-treat population (data available in 967 to 982 patients) using Bayesian models with various sensitivity analyses. Results are presented as median posterior probabilities with 95% credible intervals (CrIs) and probabilities of different effect sizes with 12 mg dexamethasone.

Results

The adjusted mean difference on days alive without life support at day 28 (primary outcome) was 1.3 days (95% CrI −0.3 to 2.9; 94.2% probability of benefit). Adjusted relative risks and probabilities of benefit on serious adverse reactions was 0.85 (0.63 to 1.16; 84.1%) and on mortality 0.87 (0.73 to 1.03; 94.8%) at day 28 and 0.88 (0.75 to 1.02; 95.1%) at day 90. Probabilities of benefit on days alive without life support and days alive out of hospital at day 90 were 85 and 95.7%, respectively. Results were largely consistent across sensitivity analyses, with relatively low probabilities of clinically important harm with 12 mg on all outcomes in all analyses.

Conclusion

We found high probabilities of benefit and low probabilities of clinically important harm with dexamethasone 12 mg versus 6 mg daily in patients with COVID-19 and severe hypoxaemia on all outcomes up to 90 days.
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Metadaten
Titel
Dexamethasone 12 mg versus 6 mg for patients with COVID-19 and severe hypoxaemia: a pre-planned, secondary Bayesian analysis of the COVID STEROID 2 trial
verfasst von
Anders Granholm
Marie Warrer Munch
Sheila Nainan Myatra
Bharath Kumar Tirupakuzhi Vijayaraghavan
Maria Cronhjort
Rebecka Rubenson Wahlin
Stephan M. Jakob
Luca Cioccari
Maj-Brit Nørregaard Kjær
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 Jha
Klaus 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
Christian Gluud
Theis Lange
Anders Perner
Publikationsdatum
10.11.2021
Verlag
Springer Berlin Heidelberg
Schlagwort
COVID-19
Erschienen in
Intensive Care Medicine / Ausgabe 1/2022
Print ISSN: 0342-4642
Elektronische ISSN: 1432-1238
DOI
https://doi.org/10.1007/s00134-021-06573-1