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Long-term outcomes of dexamethasone 12 mg versus 6 mg in patients with COVID-19 and severe hypoxaemia
journal contributionposted on 2023-02-28, 02:40 authored by A Granholm, M B N Kjær, M W Munch, S N Myatra, B K T Vijayaraghavan, M Cronhjort, R R Wahlin, S M Jakob, L Cioccari, G K Vesterlund, T S Meyhoff, M Helleberg, M H Møller, T Benfield, B Venkatesh, N E Hammond, S Micallef, A Bassi, O John, V Jha, K T Kristiansen, C S Ulrik, V L Jørgensen, M Smitt, M H Bestle, A S Andreasen, L M Poulsen, B S Rasmussen, A C Brøchner, T Strøm, A Møller, M S Khan, A Padmanaban, J V Divatia, S Saseedharan, K Borawake, F Kapadia, S Dixit, R Chawla, U Shukla, P Amin, M S Chew, C A Wamberg, N Bose, M S Shah, I S Darfelt, C Gluud, Theis Lange, A Perner
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.