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 - Brøchner, 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
N1 - © 2022. Springer-Verlag GmbH Germany, part of Springer Nature.
PY - 2022/5
Y1 - 2022/5
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 - Corticosteroids
KW - COVID-19
KW - Critical illness
KW - Hypoxaemia
KW - Mortality
KW - Quality of life
KW - Dexamethasone/administration & dosage
KW - COVID-19/complications
KW - Humans
KW - Hypoxia/complications
KW - Treatment Outcome
KW - Dose-Response Relationship, Drug
KW - Patient Acuity
KW - Quality of Life
KW - Adult
KW - Surveys and Questionnaires
UR - http://www.scopus.com/inward/record.url?scp=85127422999&partnerID=8YFLogxK
U2 - 10.1007/s00134-022-06677-2
DO - 10.1007/s00134-022-06677-2
M3 - Journal article
C2 - 35359168
SN - 0342-4642
VL - 48
SP - 580
EP - 589
JO - Intensive Care Medicine
JF - Intensive Care Medicine
IS - 5
ER -