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

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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).

OriginalsprogEngelsk
Artikelnummer2052
TidsskriftBiomedicines
Vol/bind11
Udgave nummer7
Sider (fra-til)1-14
ISSN2227-9059
DOI
StatusUdgivet - 2023

Bibliografisk note

Funding Information:
P.K., E.R., P.S. and J.U.S.J. were funded by the Novo Nordisk Foundation (NNF20OC0060657). J.V. was supported by the NIHR Manchester BRC (NIHR203308). Funding parties had no influence on the design of the study, data collection, data analysis, interpretation of data or writing of the manuscript.

Publisher Copyright:
© 2023 by the authors.

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