Effects of 12 mg vs. 6 mg dexamethasone on thromboembolism and bleeding in patients with critical COVID-19 - a post hoc analysis of the randomized, blinded COVID STEROID 2 trial
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Effects of 12 mg vs. 6 mg dexamethasone on thromboembolism and bleeding in patients with critical COVID-19 - a post hoc analysis of the randomized, blinded COVID STEROID 2 trial. / Jonmarker, Sandra; Alarcón, Felix; Litorell, Jacob; Granholm, Anders; Alm, Eva Joelsson; Chew, Michelle; Russell, Lene; Weihe, Sarah; Madsen, Emilie Kabel; Meier, Nick; Leistner, Jens Wolfgang; Mårtensson, Johan; Hollenberg, Jacob; Perner, Anders; Kjær, Maj Brit Nørregaard; Munch, Marie Warrer; Dahlberg, Martin; Cronhjort, Maria; Wahlin, Rebecka Rubenson.
I: Annals of Intensive Care, Bind 13, Nr. 1, 12, 2023.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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T1 - Effects of 12 mg vs. 6 mg dexamethasone on thromboembolism and bleeding in patients with critical COVID-19 - a post hoc analysis of the randomized, blinded COVID STEROID 2 trial
AU - Jonmarker, Sandra
AU - Alarcón, Felix
AU - Litorell, Jacob
AU - Granholm, Anders
AU - Alm, Eva Joelsson
AU - Chew, Michelle
AU - Russell, Lene
AU - Weihe, Sarah
AU - Madsen, Emilie Kabel
AU - Meier, Nick
AU - Leistner, Jens Wolfgang
AU - Mårtensson, Johan
AU - Hollenberg, Jacob
AU - Perner, Anders
AU - Kjær, Maj Brit Nørregaard
AU - Munch, Marie Warrer
AU - Dahlberg, Martin
AU - Cronhjort, Maria
AU - Wahlin, Rebecka Rubenson
PY - 2023
Y1 - 2023
N2 - Background: Thromboembolism is more common in patients with critical COVID-19 than in other critically ill patients, and inflammation has been proposed as a possible mechanism. The aim of this study was to investigate if 12 mg vs. 6 mg dexamethasone daily reduced the composite outcome of death or thromboembolism in patients with critical COVID-19. Methods: Using additional data on thromboembolism and bleeding we did a post hoc analysis of Swedish and Danish intensive care unit patients enrolled in the blinded randomized COVID STEROID 2 trial comparing 12 mg vs. 6 mg dexamethasone daily for up to 10 days. The primary outcome was a composite outcome of death or thromboembolism during intensive care. Secondary outcomes were thromboembolism, major bleeding, and any bleeding during intensive care. Results: We included 357 patients. Whilst in intensive care, 53 patients (29%) in the 12 mg group and 53 patients (30%) in the 6 mg group met the primary outcome with an unadjusted absolute risk difference of − 0.5% (95% CI − 10 to 9.5%, p = 1.00) and an adjusted OR of 0.93 (CI 95% 0.58 to 1.49, p = 0.77). We found no firm evidence of differences in any of the secondary outcomes. Conclusions: Among patients with critical COVID-19, 12 mg vs. 6 mg dexamethasone daily did not result in a statistically significant difference in the composite outcome of death or thromboembolism. However, uncertainty remains due to the limited number of patients.
AB - Background: Thromboembolism is more common in patients with critical COVID-19 than in other critically ill patients, and inflammation has been proposed as a possible mechanism. The aim of this study was to investigate if 12 mg vs. 6 mg dexamethasone daily reduced the composite outcome of death or thromboembolism in patients with critical COVID-19. Methods: Using additional data on thromboembolism and bleeding we did a post hoc analysis of Swedish and Danish intensive care unit patients enrolled in the blinded randomized COVID STEROID 2 trial comparing 12 mg vs. 6 mg dexamethasone daily for up to 10 days. The primary outcome was a composite outcome of death or thromboembolism during intensive care. Secondary outcomes were thromboembolism, major bleeding, and any bleeding during intensive care. Results: We included 357 patients. Whilst in intensive care, 53 patients (29%) in the 12 mg group and 53 patients (30%) in the 6 mg group met the primary outcome with an unadjusted absolute risk difference of − 0.5% (95% CI − 10 to 9.5%, p = 1.00) and an adjusted OR of 0.93 (CI 95% 0.58 to 1.49, p = 0.77). We found no firm evidence of differences in any of the secondary outcomes. Conclusions: Among patients with critical COVID-19, 12 mg vs. 6 mg dexamethasone daily did not result in a statistically significant difference in the composite outcome of death or thromboembolism. However, uncertainty remains due to the limited number of patients.
KW - Bleeding
KW - COVID-19
KW - Glucocorticoids
KW - Intensive care
KW - Pulmonary embolism
KW - Steroids
KW - Thromboembolism
KW - Thrombosis
U2 - 10.1186/s13613-023-01115-y
DO - 10.1186/s13613-023-01115-y
M3 - Journal article
C2 - 36862239
VL - 13
JO - Annals of Intensive Care
JF - Annals of Intensive Care
SN - 2110-5820
IS - 1
M1 - 12
ER -
ID: 342691849