학술논문
Long-term outcomes of dexamethasone 12 mg versus 6 mg in patients with COVID-19 and severe hypoxaemia
Document Type
Original Paper
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; 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; Bose, Neeta; Shah, Mehul S.; Darfelt, Iben S.; Gluud, Christian; Lange, Theis; Perner, Anders
Source
Intensive Care Medicine. 48(5):580-589
Subject
Language
English
ISSN
0342-4642
1432-1238
1432-1238
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.