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November 23, 2015Clinical Drug InvestigationOpen Access

Switching from dabigatran to edoxaban resulted in a higher aPTT at 2 h compared to edoxaban alone (47.6 vs 35.0 s, difference 12.8 s, 95% CI 10.5-15.1; p < 0.0001), while switching from rivaroxaban resulted in similar peak PT (21.8 ± 2.88 s vs 21.8 ± 2.46 s).

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Why the study?

Does switching from rivaroxaban or dabigatran to edoxaban affect pharmacokinetic and pharmacodynamic parameters in healthy subjects?

Population

Healthy subjects

Comparison

Edoxaban 60 mg on day 4 after 3 days of… vs Edoxaban 60 mg daily alone for 4 days

Design

Other, open-label

Follow-up

4 days per period

Authors

DPDolly A. ParasrampuriaDWDoris WeilertJMJen‐Fue Maa

Discussion

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Overview

Supports next-dose switching to edoxaban in practice; leaves open effects on clinical outcomes in patients.

Structured PICO

Does switching from rivaroxaban or dabigatran to edoxaban affect pharmacokinetic and pharmacodynamic parameters in healthy subjects?

P
Population
Healthy subjects
I
Intervention
Edoxaban 60 mg on day 4 after 3 days of rivaroxaban 20 mg daily or dabigatran etexilate 150 mg twice daily
C
Comparator
Edoxaban 60 mg daily alone for 4 days
O
Outcome
Pharmacokinetic parameters and pharmacodynamic effects (prothrombin time [PT] and activated partial thromboplastin time [aPTT])surrogate

Switching from rivaroxaban or dabigatran to edoxaban at the time of the next dose is well tolerated and maintains coagulation status, despite a transient carryover effect on aPTT from dabigatran.

Cite This Study

Parasrampuria et al. (2015) studied this question.

synapsesocial.com/papers/6a912ac5a84e8635244657aahttps://doi.org/10.1007/s40261-015-0357-8
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1A randomized trial of the safety, pharmacokinetics and pharmacodynamics of edoxaban, an oral factor <scp>Xa</scp> inhibitor, following a switch from warfarin2012 · 42 citations
  2. 2Edoxaban administration following enoxaparin: A pharmacodynamic, pharmacokinetic, and tolerability assessment in human subjects2012 · 39 citations
  3. 3Pharmacokinetics and Pharmacodynamics of Edoxaban, a Non-Vitamin K Antagonist Oral Anticoagulant that Inhibits Clotting Factor Xa2015 · 230 citations
  4. 4Edoxaban in the prevention and treatment of thromboembolic complications from a clinical point of view2015 · 7 citations
  5. 5Clinical Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Novel Factor Xa Inhibitor Edoxaban in Healthy Volunteers2010 · 454 citations