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Effect of 10-Day Treatment with 50 mg Prednisolone Once-Daily on Haemostasis in Healthy Men—A Randomised Placebo-Controlled Trial

Synthetic corticosteroids are widely used due to their anti-inflammatory and immunosuppressant effects. Their use has been associated with venous thromboembolism, but it is unknown whether thromboembolism has a causal relationship with corticosteroid treatment. In a randomised, double-blind, placebo...

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Autores principales: Kamstrup, Peter, Rastoder, Ema, Hellmann, Pernille Høgh, Sivapalan, Pradeesh, Larsen, Emil List, Vestbo, Jørgen, Ulrik, Charlotte Suppli, Goetze, Jens P., Knop, Filip Krag, Jensen, Jens Ulrik Stæhr
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10377059/
https://www.ncbi.nlm.nih.gov/pubmed/37509691
http://dx.doi.org/10.3390/biomedicines11072052
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author Kamstrup, Peter
Rastoder, Ema
Hellmann, Pernille Høgh
Sivapalan, Pradeesh
Larsen, Emil List
Vestbo, Jørgen
Ulrik, Charlotte Suppli
Goetze, Jens P.
Knop, Filip Krag
Jensen, Jens Ulrik Stæhr
author_facet Kamstrup, Peter
Rastoder, Ema
Hellmann, Pernille Høgh
Sivapalan, Pradeesh
Larsen, Emil List
Vestbo, Jørgen
Ulrik, Charlotte Suppli
Goetze, Jens P.
Knop, Filip Krag
Jensen, Jens Ulrik Stæhr
author_sort Kamstrup, Peter
collection PubMed
description Synthetic corticosteroids are widely used due to their anti-inflammatory and immunosuppressant effects. Their use has been associated with venous thromboembolism, but it is unknown whether thromboembolism has a causal relationship with corticosteroid treatment. In a randomised, double-blind, placebo-controlled trial in normal to overweight healthy men, the effect of the corticosteroid prednisolone on haemostasis using either 50 mg prednisolone or matching placebo once daily for ten days was investigated. The primary outcome was a change from baseline in the viscoelastic measurement maximal amplitude of clot in kaolin-activated thromboelastography (TEG). Changes from baseline in other TEG measurements, D-dimer, von Willebrand factor (VWF) antigen, and ristocetin cofactor activity (RCo), antithrombin, protein C, prothrombin, fibrinogen, INR, APTT, and platelet count were secondary outcomes. Thirty-four men participated in this study. Compared to placebo, prednisolone treatment did not affect maximal amplitude of clot (difference −0.77 (95% confidence interval (CI) −2.48, 0.94) mm, p = 0.37, missing: n = 2), but it altered VWF antigen (28%, p = 0.0004), VWF:RCo (19%, p = 0.0006), prothrombin (5%, p = 0.05), protein C (31%, p < 0.0001), antithrombin (5%, p = 0.013), and fibrinogen (−15%, p = 0.004). Thus, prednisolone treatment did not alter TEG-assessed maximal amplitude of clot, despite that it affected prothrombotic markers (increased prothrombin, VWF antigen, VWF:RCo, prothrombin, and decreased fibrinogen) and increased antithrombotic markers (protein C and antithrombin).
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spelling pubmed-103770592023-07-29 Effect of 10-Day Treatment with 50 mg Prednisolone Once-Daily on Haemostasis in Healthy Men—A Randomised Placebo-Controlled Trial Kamstrup, Peter Rastoder, Ema Hellmann, Pernille Høgh Sivapalan, Pradeesh Larsen, Emil List Vestbo, Jørgen Ulrik, Charlotte Suppli Goetze, Jens P. Knop, Filip Krag Jensen, Jens Ulrik Stæhr Biomedicines Article Synthetic corticosteroids are widely used due to their anti-inflammatory and immunosuppressant effects. Their use has been associated with venous thromboembolism, but it is unknown whether thromboembolism has a causal relationship with corticosteroid treatment. In a randomised, double-blind, placebo-controlled trial in normal to overweight healthy men, the effect of the corticosteroid prednisolone on haemostasis using either 50 mg prednisolone or matching placebo once daily for ten days was investigated. The primary outcome was a change from baseline in the viscoelastic measurement maximal amplitude of clot in kaolin-activated thromboelastography (TEG). Changes from baseline in other TEG measurements, D-dimer, von Willebrand factor (VWF) antigen, and ristocetin cofactor activity (RCo), antithrombin, protein C, prothrombin, fibrinogen, INR, APTT, and platelet count were secondary outcomes. Thirty-four men participated in this study. Compared to placebo, prednisolone treatment did not affect maximal amplitude of clot (difference −0.77 (95% confidence interval (CI) −2.48, 0.94) mm, p = 0.37, missing: n = 2), but it altered VWF antigen (28%, p = 0.0004), VWF:RCo (19%, p = 0.0006), prothrombin (5%, p = 0.05), protein C (31%, p < 0.0001), antithrombin (5%, p = 0.013), and fibrinogen (−15%, p = 0.004). Thus, prednisolone treatment did not alter TEG-assessed maximal amplitude of clot, despite that it affected prothrombotic markers (increased prothrombin, VWF antigen, VWF:RCo, prothrombin, and decreased fibrinogen) and increased antithrombotic markers (protein C and antithrombin). MDPI 2023-07-21 /pmc/articles/PMC10377059/ /pubmed/37509691 http://dx.doi.org/10.3390/biomedicines11072052 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Kamstrup, Peter
Rastoder, Ema
Hellmann, Pernille Høgh
Sivapalan, Pradeesh
Larsen, Emil List
Vestbo, Jørgen
Ulrik, Charlotte Suppli
Goetze, Jens P.
Knop, Filip Krag
Jensen, Jens Ulrik Stæhr
Effect of 10-Day Treatment with 50 mg Prednisolone Once-Daily on Haemostasis in Healthy Men—A Randomised Placebo-Controlled Trial
title Effect of 10-Day Treatment with 50 mg Prednisolone Once-Daily on Haemostasis in Healthy Men—A Randomised Placebo-Controlled Trial
title_full Effect of 10-Day Treatment with 50 mg Prednisolone Once-Daily on Haemostasis in Healthy Men—A Randomised Placebo-Controlled Trial
title_fullStr Effect of 10-Day Treatment with 50 mg Prednisolone Once-Daily on Haemostasis in Healthy Men—A Randomised Placebo-Controlled Trial
title_full_unstemmed Effect of 10-Day Treatment with 50 mg Prednisolone Once-Daily on Haemostasis in Healthy Men—A Randomised Placebo-Controlled Trial
title_short Effect of 10-Day Treatment with 50 mg Prednisolone Once-Daily on Haemostasis in Healthy Men—A Randomised Placebo-Controlled Trial
title_sort effect of 10-day treatment with 50 mg prednisolone once-daily on haemostasis in healthy men—a randomised placebo-controlled trial
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10377059/
https://www.ncbi.nlm.nih.gov/pubmed/37509691
http://dx.doi.org/10.3390/biomedicines11072052
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