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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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.
In: Biomedicines, Vol. 11, No. 7, 2052, 2023, p. 1-14.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Effect of 10-Day Treatment with 50 mg Prednisolone Once-Daily on Haemostasis in Healthy Men—A Randomised Placebo-Controlled Trial
AU - Kamstrup, Peter
AU - Rastoder, Ema
AU - Hellmann, Pernille Høgh
AU - Sivapalan, Pradeesh
AU - Larsen, Emil List
AU - Vestbo, Jørgen
AU - Ulrik, Charlotte Suppli
AU - Goetze, Jens P.
AU - Knop, Filip Krag
AU - Jensen, Jens Ulrik Stæhr
N1 - Publisher Copyright: © 2023 by the authors.
PY - 2023
Y1 - 2023
N2 - 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).
AB - 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).
KW - biomarkers
KW - glucocorticoids
KW - haemostasis
KW - healthy volunteers
KW - randomised controlled trial
KW - thromboelastography
U2 - 10.3390/biomedicines11072052
DO - 10.3390/biomedicines11072052
M3 - Journal article
C2 - 37509691
AN - SCOPUS:85175109648
VL - 11
SP - 1
EP - 14
JO - Biomedicines
JF - Biomedicines
SN - 2227-9059
IS - 7
M1 - 2052
ER -
ID: 373470273