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January 1, 2012Thrombosis and Haemostasis

Edoxaban 60 mg can be safely administered 12 h following enoxaparin 1 mg/kg, with neither drug significantly altering the pharmacokinetics of the other and no serious adverse events observed.

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Why the study?

Does enoxaparin followed 12 hours later by edoxaban alter pharmacodynamics, pharmacokinetics, or safety compared to either drug alone or co-administration in human subjects?

Population

Human subjects

Comparison

Enoxaparin 1 mg/kg followed 12 hours post-dose… vs Edoxaban alone, enoxaparin alone, and edoxaban…

Design

RCT, randomised, four-period, four-treatment cross-over, open-label

Authors

NMNobuko MatsushimaAHAbdel‐Baset HalimLHLing He

Discussion

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Overview

Supports 12-hour enoxaparin-to-edoxaban transition in practice; reinforces trial bridging regimens with RCT pharmacokinetic confirmation.

Structured PICO

Does enoxaparin followed 12 hours later by edoxaban alter pharmacodynamics, pharmacokinetics, or safety compared to either drug alone or co-administration in human subjects?

P
Population
Human subjects
I
Intervention
Enoxaparin 1 mg/kg followed 12 hours post-dose by edoxaban 60 mg
C
Comparator
Edoxaban alone, enoxaparin alone, and edoxaban plus enoxaparin
O
Outcome
Pharmacodynamics (thrombin generation, anti-FXa) and safetysurrogate

Edoxaban 60 mg can be safely administered 12 hours following enoxaparin 1 mg/kg without significant pharmacokinetic interactions, supporting the transition regimen used in clinical trials.

Cite This Study

Matsushima et al. (2012) studied this question.

synapsesocial.com/papers/6a800210485cf8e532e452b6https://doi.org/10.1160/th11-09-0676
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