tetano
Editor, Senior Moderator
Intensive Care Med
. 2022 Mar 31;1-10.
doi: 10.1007/s00134-022-06677-2. Online ahead of print.
Long-term outcomes of dexamethasone 12 mg versus 6 mg in patients with COVID-19 and severe hypoxaemia
Anders Granholm[SUP] 1 2 [/SUP], Maj-Brit Nørregaard Kjær[SUP] 1 2 [/SUP], Marie Warrer Munch[SUP] 1 2 [/SUP], Sheila Nainan Myatra[SUP] 3 [/SUP], Bharath Kumar Tirupakuzhi Vijayaraghavan[SUP] 4 5 6 [/SUP], Maria Cronhjort[SUP] 7 [/SUP], Rebecka Rubenson Wahlin[SUP] 7 [/SUP], Stephan M Jakob[SUP] 8 [/SUP], Luca Cioccari[SUP] 8 [/SUP], Gitte Kingo Vesterlund[SUP] 1 2 [/SUP], Tine Sylvest Meyhoff[SUP] 1 2 [/SUP], Marie Helleberg[SUP] 9 [/SUP], Morten Hylander Møller[SUP] 1 2 [/SUP], Thomas Benfield[SUP] 10 [/SUP], Balasubramanian Venkatesh[SUP] 11 [/SUP], Naomi E Hammond[SUP] 11 12 [/SUP], Sharon Micallef[SUP] 11 [/SUP], Abhinav Bassi[SUP] 5 [/SUP], Oommen John[SUP] 5 13 [/SUP], Vivekanand Jha[SUP] 5 13 14 [/SUP], Klaus Tjelle Kristiansen[SUP] 15 [/SUP], Charlotte Suppli Ulrik[SUP] 16 [/SUP], Vibeke Lind Jørgensen[SUP] 17 [/SUP], Margit Smitt[SUP] 18 [/SUP], Morten H Bestle[SUP] 19 20 [/SUP], Anne Sofie Andreasen[SUP] 21 [/SUP], Lone Musaeus Poulsen[SUP] 22 [/SUP], Bodil Steen Rasmussen[SUP] 2 23 [/SUP], Anne Craveiro Brøchner[SUP] 2 24 [/SUP], Thomas Strøm[SUP] 25 26 [/SUP], Anders Møller[SUP] 27 [/SUP], Mohd Saif Khan[SUP] 28 [/SUP], Ajay Padmanaban[SUP] 4 [/SUP], Jigeeshu Vasishtha Divatia[SUP] 3 [/SUP], Sanjith Saseedharan[SUP] 29 [/SUP], Kapil Borawake[SUP] 30 [/SUP], Farhad Kapadia[SUP] 31 [/SUP], Subhal Dixit[SUP] 32 [/SUP], Rajesh Chawla[SUP] 33 [/SUP], Urvi Shukla[SUP] 34 [/SUP], Pravin Amin[SUP] 35 [/SUP], Michelle S Chew[SUP] 36 [/SUP], Christian Aage Wamberg[SUP] 37 [/SUP], Neeta Bose[SUP] 38 [/SUP], Mehul S Shah[SUP] 39 [/SUP], Iben S Darfelt[SUP] 40 [/SUP], Christian Gluud[SUP] 41 42 [/SUP], Theis Lange[SUP] 43 [/SUP], Anders Perner[SUP] 44 45 46 [/SUP]
Affiliations
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.
Trial registration: ClinicalTrials.gov NCT04509973.
Keywords: COVID-19; Corticosteroids; Critical illness; Hypoxaemia; Mortality; Quality of life.
. 2022 Mar 31;1-10.
doi: 10.1007/s00134-022-06677-2. Online ahead of print.
Long-term outcomes of dexamethasone 12 mg versus 6 mg in patients with COVID-19 and severe hypoxaemia
Anders Granholm[SUP] 1 2 [/SUP], Maj-Brit Nørregaard Kjær[SUP] 1 2 [/SUP], Marie Warrer Munch[SUP] 1 2 [/SUP], Sheila Nainan Myatra[SUP] 3 [/SUP], Bharath Kumar Tirupakuzhi Vijayaraghavan[SUP] 4 5 6 [/SUP], Maria Cronhjort[SUP] 7 [/SUP], Rebecka Rubenson Wahlin[SUP] 7 [/SUP], Stephan M Jakob[SUP] 8 [/SUP], Luca Cioccari[SUP] 8 [/SUP], Gitte Kingo Vesterlund[SUP] 1 2 [/SUP], Tine Sylvest Meyhoff[SUP] 1 2 [/SUP], Marie Helleberg[SUP] 9 [/SUP], Morten Hylander Møller[SUP] 1 2 [/SUP], Thomas Benfield[SUP] 10 [/SUP], Balasubramanian Venkatesh[SUP] 11 [/SUP], Naomi E Hammond[SUP] 11 12 [/SUP], Sharon Micallef[SUP] 11 [/SUP], Abhinav Bassi[SUP] 5 [/SUP], Oommen John[SUP] 5 13 [/SUP], Vivekanand Jha[SUP] 5 13 14 [/SUP], Klaus Tjelle Kristiansen[SUP] 15 [/SUP], Charlotte Suppli Ulrik[SUP] 16 [/SUP], Vibeke Lind Jørgensen[SUP] 17 [/SUP], Margit Smitt[SUP] 18 [/SUP], Morten H Bestle[SUP] 19 20 [/SUP], Anne Sofie Andreasen[SUP] 21 [/SUP], Lone Musaeus Poulsen[SUP] 22 [/SUP], Bodil Steen Rasmussen[SUP] 2 23 [/SUP], Anne Craveiro Brøchner[SUP] 2 24 [/SUP], Thomas Strøm[SUP] 25 26 [/SUP], Anders Møller[SUP] 27 [/SUP], Mohd Saif Khan[SUP] 28 [/SUP], Ajay Padmanaban[SUP] 4 [/SUP], Jigeeshu Vasishtha Divatia[SUP] 3 [/SUP], Sanjith Saseedharan[SUP] 29 [/SUP], Kapil Borawake[SUP] 30 [/SUP], Farhad Kapadia[SUP] 31 [/SUP], Subhal Dixit[SUP] 32 [/SUP], Rajesh Chawla[SUP] 33 [/SUP], Urvi Shukla[SUP] 34 [/SUP], Pravin Amin[SUP] 35 [/SUP], Michelle S Chew[SUP] 36 [/SUP], Christian Aage Wamberg[SUP] 37 [/SUP], Neeta Bose[SUP] 38 [/SUP], Mehul S Shah[SUP] 39 [/SUP], Iben S Darfelt[SUP] 40 [/SUP], Christian Gluud[SUP] 41 42 [/SUP], Theis Lange[SUP] 43 [/SUP], Anders Perner[SUP] 44 45 46 [/SUP]
Affiliations
- PMID: 35359168
- PMCID: PMC8970069
- DOI: 10.1007/s00134-022-06677-2
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.
Trial registration: ClinicalTrials.gov NCT04509973.
Keywords: COVID-19; Corticosteroids; Critical illness; Hypoxaemia; Mortality; Quality of life.