Your browser doesn't support javascript.
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.
Granholm, Anders; Munch, Marie Warrer; Myatra, Sheila Nainan; Vijayaraghavan, Bharath Kumar Tirupakuzhi; Cronhjort, Maria; Wahlin, Rebecka Rubenson; Jakob, Stephan M; Cioccari, Luca; Kjær, Maj-Brit Nørregaard; Vesterlund, Gitte Kingo; Meyhoff, Tine Sylvest; Helleberg, Marie; Møller, Morten Hylander; Benfield, Thomas; Venkatesh, Balasubramanian; Hammond, Naomi E; Micallef, Sharon; Bassi, Abhinav; John, Oommen; Jha, Vivekanand; Kristiansen, Klaus Tjelle; Ulrik, Charlotte Suppli; Jørgensen, Vibeke Lind; Smitt, Margit; Bestle, Morten H; Andreasen, Anne Sofie; Poulsen, Lone Musaeus; Rasmussen, Bodil Steen; Brøchner, Anne Craveiro; Strøm, Thomas; Møller, Anders; Khan, Mohd Saif; Padmanaban, Ajay; Divatia, Jigeeshu Vasishtha; Saseedharan, Sanjith; Borawake, Kapil; Kapadia, Farhad; Dixit, Subhal; Chawla, Rajesh; Shukla, Urvi; Amin, Pravin; Chew, Michelle S; Wamberg, Christian Aage; Gluud, Christian; Lange, Theis; Perner, Anders.
  • Granholm A; Department of Intensive Care, Rigshospitalet-Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark. andersgran@gmail.com.
  • Munch MW; Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark. andersgran@gmail.com.
  • Myatra SN; Department of Intensive Care, Rigshospitalet-Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.
  • Vijayaraghavan BKT; Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.
  • Cronhjort M; Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.
  • Wahlin RR; Department of Critical Care, Apollo Hospitals, Chennai, India.
  • Jakob SM; Chennai Critical Care Consultants, Chennai, India.
  • Cioccari L; The George Institute for Global Health, New Delhi, India.
  • Kjær MN; Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.
  • Vesterlund GK; Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.
  • Meyhoff TS; Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
  • Helleberg M; Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
  • Møller MH; Department of Intensive Care, Rigshospitalet-Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.
  • Benfield T; Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.
  • Venkatesh B; Department of Intensive Care, Rigshospitalet-Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.
  • Hammond NE; Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.
  • Micallef S; Department of Intensive Care, Rigshospitalet-Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.
  • Bassi A; Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.
  • John O; Department of Infectious Diseases, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
  • Jha V; Department of Intensive Care, Rigshospitalet-Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.
  • Kristiansen KT; Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.
  • Ulrik CS; Center of Research & Disruption of Infectious Diseases, Department of Infectious Diseases, Copenhagen University Hospital-Amager and Hvidovre, Hvidovre, Denmark.
  • Jørgensen VL; The George Institute for Global Health, University of New South Wales, Sydney, Australia.
  • Smitt M; The George Institute for Global Health, University of New South Wales, Sydney, Australia.
  • Bestle MH; Malcolm Fisher Department of Intensive Care, Royal North Shore Hospital, St Leonards, NSW, Australia.
  • Andreasen AS; The George Institute for Global Health, University of New South Wales, Sydney, Australia.
  • Poulsen LM; The George Institute for Global Health, New Delhi, India.
  • Rasmussen BS; The George Institute for Global Health, New Delhi, India.
  • Brøchner AC; Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal, India.
  • Strøm T; The George Institute for Global Health, New Delhi, India.
  • Møller A; Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal, India.
  • Khan MS; School of Public Health, Imperial College London, London, UK.
  • Padmanaban A; Department of Anaesthesia and Intensive Care, Hvidovre Hospital, University of Copenhagen, Hvidovre, Denmark.
  • Divatia JV; Department of Respiratory Medicine, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.
  • Saseedharan S; Department of Thoracic Anaesthesiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
  • Borawake K; Department of Neuroanaesthesiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
  • Kapadia F; Department of Anaesthesia and Intensive Care, Copenhagen University Hospital - North Zealand, Hillerød, Denmark.
  • Dixit S; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
  • Chawla R; Department of Anaesthesia and Intensive Care, Herlev Hospital, University of Copenhagen, Herlev, Denmark.
  • Shukla U; Department of Anaesthesiology, Zealand University Hospital, Køge, Denmark.
  • Amin P; Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.
  • Chew MS; Department of Anaesthesia and Intensive Care, Aalborg University Hospital, Aalborg, Denmark.
  • Wamberg CA; Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.
  • Gluud C; Department of Anaesthesia and Intensive Care, Kolding Hospital, University Hospital of Southern Denmark, Kolding, Denmark.
  • Lange T; Department of Anaesthesia and Critical Care Medicine, Odense University Hospital, Odense C, Denmark.
  • Perner A; Department of Anaesthesia and Critical Care Medicine, Hospital Sønderjylland, University Hospital of Southern, Odense, Denmark.
Intensive Care Med ; 48(1): 45-55, 2022 01.
Article in English | MEDLINE | ID: covidwho-1605102
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.
Subject(s)
Keywords

Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Type of study: Controlled clinical trial / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: Intensive Care Med Year: 2022 Document Type: Article Affiliation country: S00134-021-06573-1

Similar

MEDLINE

...
LILACS

LIS


Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Type of study: Controlled clinical trial / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: Intensive Care Med Year: 2022 Document Type: Article Affiliation country: S00134-021-06573-1