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

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Long-term outcomes of dexamethasone 12 mg versus 6 mg in patients with COVID-19 and severe hypoxaemia. / Granholm, Anders; Kjær, Maj-Brit Nørregaard; Munch, Marie Warrer; Myatra, Sheila Nainan; Vijayaraghavan, Bharath Kumar Tirupakuzhi; Cronhjort, Maria; Wahlin, Rebecka Rubenson; Jakob, Stephan M.; Cioccari, Luca; 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; Brochner, 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; Bose, Neeta; Shah, Mehul S.; Darfelt, Iben S.; Gluud, Christian; Lange, Theis; Perner, Anders.

I: Intensive Care Medicine, Bind 48, Nr. 5, 2022, s. 580–589.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt

Harvard

Granholm, A, Kjær, M-BN, Munch, MW, Myatra, SN, Vijayaraghavan, BKT, Cronhjort, M, Wahlin, RR, Jakob, SM, Cioccari, L, Vesterlund, GK, Meyhoff, TS, Helleberg, M, Møller, MH, Benfield, T, Venkatesh, B, Hammond, NE, Micallef, S, Bassi, A, John, O, Jha, V, Kristiansen, KT, Ulrik, CS, Jørgensen, VL, Smitt, M, Bestle, MH, Andreasen, AS, Poulsen, LM, Rasmussen, BS, Brochner, AC, Strøm, T, Møller, A, Khan, MS, Padmanaban, A, Divatia, JV, Saseedharan, S, Borawake, K, Kapadia, F, Dixit, S, Chawla, R, Shukla, U, Amin, P, Chew, MS, Wamberg, CA, Bose, N, Shah, MS, Darfelt, IS, Gluud, C, Lange, T & Perner, A 2022, 'Long-term outcomes of dexamethasone 12 mg versus 6 mg in patients with COVID-19 and severe hypoxaemia', Intensive Care Medicine, bind 48, nr. 5, s. 580–589. https://doi.org/10.1007/s00134-022-06677-2

APA

Granholm, A., Kjær, M-B. N., Munch, M. W., Myatra, S. N., Vijayaraghavan, B. K. T., Cronhjort, M., Wahlin, R. R., Jakob, S. M., Cioccari, L., Vesterlund, G. K., Meyhoff, T. S., Helleberg, M., Møller, M. H., Benfield, T., Venkatesh, B., Hammond, N. E., Micallef, S., Bassi, A., John, O., ... Perner, A. (2022). Long-term outcomes of dexamethasone 12 mg versus 6 mg in patients with COVID-19 and severe hypoxaemia. Intensive Care Medicine, 48(5), 580–589. https://doi.org/10.1007/s00134-022-06677-2

Vancouver

Granholm A, Kjær M-BN, Munch MW, Myatra SN, Vijayaraghavan BKT, Cronhjort M o.a. Long-term outcomes of dexamethasone 12 mg versus 6 mg in patients with COVID-19 and severe hypoxaemia. Intensive Care Medicine. 2022;48(5):580–589. https://doi.org/10.1007/s00134-022-06677-2

Author

Granholm, Anders ; Kjær, Maj-Brit Nørregaard ; Munch, Marie Warrer ; Myatra, Sheila Nainan ; Vijayaraghavan, Bharath Kumar Tirupakuzhi ; Cronhjort, Maria ; Wahlin, Rebecka Rubenson ; Jakob, Stephan M. ; Cioccari, Luca ; 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 ; Brochner, 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 ; Bose, Neeta ; Shah, Mehul S. ; Darfelt, Iben S. ; Gluud, Christian ; Lange, Theis ; Perner, Anders. / Long-term outcomes of dexamethasone 12 mg versus 6 mg in patients with COVID-19 and severe hypoxaemia. I: Intensive Care Medicine. 2022 ; Bind 48, Nr. 5. s. 580–589.

Bibtex

@article{a2b2943f5fc14888884885b57fb2b277,

title = "Long-term outcomes of dexamethasone 12 mg versus 6 mg in patients with COVID-19 and severe hypoxaemia",

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.",

keywords = "COVID-19, Hypoxaemia, Critical illness, Corticosteroids, Quality of life, Mortality",

author = "Anders Granholm and Kj{\ae}r, {Maj-Brit N{\o}rregaard} and Munch, {Marie Warrer} and Myatra, {Sheila Nainan} and Vijayaraghavan, {Bharath Kumar Tirupakuzhi} and Maria Cronhjort and Wahlin, {Rebecka Rubenson} and Jakob, {Stephan M.} and Luca Cioccari and Vesterlund, {Gitte Kingo} and Meyhoff, {Tine Sylvest} and Marie Helleberg and M{\o}ller, {Morten Hylander} and Thomas Benfield and Balasubramanian Venkatesh and Hammond, {Naomi E.} and Sharon Micallef and Abhinav Bassi and Oommen John and Vivekanand Jha and Kristiansen, {Klaus Tjelle} and Ulrik, {Charlotte Suppli} and J{\o}rgensen, {Vibeke Lind} and Margit Smitt and Bestle, {Morten H.} and Andreasen, {Anne Sofie} and Poulsen, {Lone Musaeus} and Rasmussen, {Bodil Steen} and Brochner, {Anne Craveiro} and Thomas Str{\o}m and Anders M{\o}ller and Khan, {Mohd Saif} and Ajay Padmanaban and Divatia, {Jigeeshu Vasishtha} and Sanjith Saseedharan and Kapil Borawake and Farhad Kapadia and Subhal Dixit and Rajesh Chawla and Urvi Shukla and Pravin Amin and Chew, {Michelle S.} and Wamberg, {Christian Aage} and Neeta Bose and Shah, {Mehul S.} and Darfelt, {Iben S.} and Christian Gluud and Theis Lange and Anders Perner",

year = "2022",

doi = "10.1007/s00134-022-06677-2",

language = "English",

volume = "48",

pages = "580–589",

journal = "European Journal of Intensive Care Medicine",

issn = "0935-1701",

publisher = "Springer",

number = "5",

}

RIS

TY - JOUR

T1 - Long-term outcomes of dexamethasone 12 mg versus 6 mg in patients with COVID-19 and severe hypoxaemia

AU - Granholm, Anders

AU - Kjær, Maj-Brit Nørregaard

AU - Munch, Marie Warrer

AU - Myatra, Sheila Nainan

AU - Vijayaraghavan, Bharath Kumar Tirupakuzhi

AU - Cronhjort, Maria

AU - Wahlin, Rebecka Rubenson

AU - Jakob, Stephan M.

AU - Cioccari, Luca

AU - Vesterlund, Gitte Kingo

AU - Meyhoff, Tine Sylvest

AU - Helleberg, Marie

AU - Møller, Morten Hylander

AU - Benfield, Thomas

AU - Venkatesh, Balasubramanian

AU - Hammond, Naomi E.

AU - Micallef, Sharon

AU - Bassi, Abhinav

AU - John, Oommen

AU - Jha, Vivekanand

AU - Kristiansen, Klaus Tjelle

AU - Ulrik, Charlotte Suppli

AU - Jørgensen, Vibeke Lind

AU - Smitt, Margit

AU - Bestle, Morten H.

AU - Andreasen, Anne Sofie

AU - Poulsen, Lone Musaeus

AU - Rasmussen, Bodil Steen

AU - Brochner, Anne Craveiro

AU - Strøm, Thomas

AU - Møller, Anders

AU - Khan, Mohd Saif

AU - Padmanaban, Ajay

AU - Divatia, Jigeeshu Vasishtha

AU - Saseedharan, Sanjith

AU - Borawake, Kapil

AU - Kapadia, Farhad

AU - Dixit, Subhal

AU - Chawla, Rajesh

AU - Shukla, Urvi

AU - Amin, Pravin

AU - Chew, Michelle S.

AU - Wamberg, Christian Aage

AU - Bose, Neeta

AU - Shah, Mehul S.

AU - Darfelt, Iben S.

AU - Gluud, Christian

AU - Lange, Theis

AU - Perner, Anders

PY - 2022

Y1 - 2022

N2 - 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.

AB - 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.

KW - COVID-19

KW - Hypoxaemia

KW - Critical illness

KW - Corticosteroids

KW - Quality of life

KW - Mortality

U2 - 10.1007/s00134-022-06677-2

DO - 10.1007/s00134-022-06677-2

M3 - Journal article

C2 - 35359168

VL - 48

SP - 580

EP - 589

JO - European Journal of Intensive Care Medicine

JF - European Journal of Intensive Care Medicine

SN - 0935-1701

IS - 5

ER -

ID: 303573627