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
© 2023. The Author(s)..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:13 |
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| Enthalten in: |
Annals of intensive care - 13(2023), 1 vom: 02. März, Seite 12 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Jonmarker, Sandra [VerfasserIn] |
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| Links: |
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| Themen: |
Bleeding |
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| Anmerkungen: |
Date Revised 06.03.2023 published: Electronic Citation Status PubMed-not-MEDLINE |
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| doi: |
10.1186/s13613-023-01115-y |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM353681903 |
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| 245 | 1 | 0 | |a 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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| 520 | |a © 2023. The Author(s). | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Bleeding | |
| 650 | 4 | |a COVID-19 | |
| 650 | 4 | |a Glucocorticoids | |
| 650 | 4 | |a Intensive care | |
| 650 | 4 | |a Pulmonary embolism | |
| 650 | 4 | |a Steroids | |
| 650 | 4 | |a Thromboembolism | |
| 650 | 4 | |a Thrombosis | |
| 700 | 1 | |a Alarcón, Felix |e verfasserin |4 aut | |
| 700 | 1 | |a Litorell, Jacob |e verfasserin |4 aut | |
| 700 | 1 | |a Granholm, Anders |e verfasserin |4 aut | |
| 700 | 1 | |a Alm, Eva Joelsson |e verfasserin |4 aut | |
| 700 | 1 | |a Chew, Michelle |e verfasserin |4 aut | |
| 700 | 1 | |a Russell, Lene |e verfasserin |4 aut | |
| 700 | 1 | |a Weihe, Sarah |e verfasserin |4 aut | |
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