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Oral anticoagulation with edoxaban. Focus on current phase III clinical development
1Heart Center Freiburg University, Freiburg, Germany. ingo.ahrens@universitaets-herzzentrum.de
Hamostaseologie
|July 13, 2012
Summary
Edoxaban, a direct factor Xa inhibitor, is a new oral anticoagulant. It is being evaluated in large clinical trials for stroke prevention in atrial fibrillation and venous thromboembolism treatment.
Area of Science:
- Pharmacology
- Clinical Medicine
- Thrombosis
Background:
- Edoxaban is an orally available direct factor Xa inhibitor, derived from DX-9065a.
- It exhibits a Tmax of 1-2 hours and a half-life of approximately 10 hours.
- Edoxaban is the third direct factor Xa inhibitor approved for preventing venous thromboembolism post-orthopaedic surgery.
Purpose of the Study:
- To discuss the pharmacological properties of edoxaban.
- To review edoxaban's late-stage clinical development.
- Focus on stroke and venous thromboembolism prevention.
Main Methods:
- Phase III clinical trials: ENGAGE AF-TIMI 48 (NCT00781391) and HOKUSAI VTE (NCT00986154).
- ENGAGE AF-TIMI 48 enrolled 21,107 patients for stroke prevention in non-valvular atrial fibrillation.
- HOKUSAI VTE planned enrollment of 7,500 patients for venous thromboembolism treatment and prevention.
Main Results:
- Edoxaban demonstrates favorable pharmacokinetic properties.
- Ongoing large-scale trials assess its efficacy and safety.
- Results are anticipated to inform clinical practice for anticoagulation.
Conclusions:
- Edoxaban is a promising oral anticoagulant with potential applications in stroke and VTE prevention.
- Its development represents significant advancement in factor Xa inhibition.
- Further data from ongoing trials will solidify its clinical role.
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