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

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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 ^{1 2} , Maj-Brit Nørregaard Kjær ^{1 2} , Marie Warrer Munch ^{1 2} , Sheila Nainan Myatra ³ , Bharath Kumar Tirupakuzhi Vijayaraghavan ^{4 5 6} , Maria Cronhjort ⁷ , Rebecka Rubenson Wahlin ⁷ , Stephan M Jakob ⁸ , Luca Cioccari ⁸ , Gitte Kingo Vesterlund ^{1 2} , Tine Sylvest Meyhoff ^{1 2} , Marie Helleberg ⁹ , Morten Hylander Møller ^{1 2} , Thomas Benfield ¹⁰ , Balasubramanian Venkatesh ¹¹ , Naomi E Hammond ^{11 12} , Sharon Micallef ¹¹ , Abhinav Bassi ⁵ , Oommen John ^{5 13} , Vivekanand Jha ^{5 13 14} , Klaus Tjelle Kristiansen ¹⁵ , Charlotte Suppli Ulrik ¹⁶ , Vibeke Lind Jørgensen ¹⁷ , Margit Smitt ¹⁸ , Morten H Bestle ^{19 20} , Anne Sofie Andreasen ²¹ , Lone Musaeus Poulsen ²² , Bodil Steen Rasmussen ^{2 23} , Anne Craveiro Brøchner ^{2 24} , Thomas Strøm ^{25 26} , Anders Møller ²⁷ , Mohd Saif Khan ²⁸ , Ajay Padmanaban ⁴ , Jigeeshu Vasishtha Divatia ³ , Sanjith Saseedharan ²⁹ , Kapil Borawake ³⁰ , Farhad Kapadia ³¹ , Subhal Dixit ³² , Rajesh Chawla ³³ , Urvi Shukla ³⁴ , Pravin Amin ³⁵ , Michelle S Chew ³⁶ , Christian Aage Wamberg ³⁷ , Neeta Bose ³⁸ , Mehul S Shah ³⁹ , Iben S Darfelt ⁴⁰ , Christian Gluud ^{41 42} , Theis Lange ⁴³ , Anders Perner ^{44 45 46}



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.