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Comparison of a direct Factor Xa inhibitor, edoxaban, with dalteparin and ximelagatran: A randomised controlled trial in healthy elderly adults.

Summary of "Comparison of a direct Factor Xa inhibitor, edoxaban, with dalteparin and ximelagatran: A randomised controlled trial in healthy elderly adults."


INTRODUCTION:
Edoxaban (the free base of DU-176b) is a new, oral direct Factor Xa inhibitor. This is the first study to compare the hemostatic response to edoxaban, ximelagatran, and dalteparin in healthy, elderly adults. MATERIALS AND
METHODS:
In this open-label, active-controlled clinical trial, 40 adults (65-75years), were randomised to: oral edoxaban (60mg, twice-daily, 7 doses), subcutaneous dalteparin (5000IU, once-daily, 4 doses), oral ximelagatran (24mg, twice-daily, 7 doses) or no drug. Blood samples were taken before, and 1.5, 4, 12, 24, 72, 84, 96, 108, 120, and 144 hours after, the first dose. The primary outcomes were changes in thrombin-antithrombin complex, prothrombin fragment 1+2 and D-dimer, and adverse events. Additional biomarkers of coagulation, and endothelial cell and platelet activation were compared (ANOVA).
RESULTS:
All subjects completed the study. Inhibition of thrombin generation lag time, peak, and constant velocity index were significantly greater, and extended for a longer period of time, following edoxaban administration, compared with dalteparin. We found that the traditional assay for anti-FXa activity was not appropriate for the new anticoagulants. Biomarker changes following edoxaban administration (including prolongation of prothrombin time) reflected inhibition of Factor Xa; there was no effect on platelet, tissue factor or endothelial activation. There were no clinically significant changes in primary outcomes. No serious adverse events were reported.
CONCLUSION:
Oral administration of edoxaban resulted in effective Factor Xa and TG inhibition, and was well-tolerated. Studies are needed to confirm edoxaban (60mg daily) use in clinical practice.
SPONSORSHIP:
Daiichi Sankyo Pharma Development.

Affiliation

Biomnis, 78 Avenue de Verdun, 94208 Ivry-sur-Seine Cedex, France.

Journal Details

This article was published in the following journal.

Name: Thrombosis research
ISSN: 1879-2472
Pages:

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