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Darexaban (YM150) prevents venous thromboembolism in Japanese patients undergoing major abdominal surgery: Phase III
Masato Sakon1, Mashio Nakamura
1Department of Surgery, Nishinomiya Municipal Central Hospital, Nishinomiya, Japan. sakon@nishi.or.jp
Introduction:
Darexaban (YM150) is an oral direct factor Xa inhibitor in clinical development for prophylaxis of venous thromboembolism (VTE) after major orthopaedic surgery. The objective of this study was to assess the efficacy and safety of darexaban 15 mg twice daily (bid) in Japanese patients undergoing major abdominal surgery.
Materials And Methods:
In a Phase III, multicentre, randomized, open-label, mechanical prophylaxis-controlled, parallel-group study, adult patients (aged ≥ 40 years) were randomized to darexaban 15 mg bid or mechanical prophylaxis, for 28 days. The primary efficacy outcome was incidence of total VTE at Day 12. Adverse events (AEs) and bleeding events were recorded throughout the study.
Results:
The total VTE incidence at Day 12 was 2.6% in the darexaban 15 mg bid group (95% confidence interval [CI]: 0.32, 9.07), compared with 15.0% (95% CI: 5.71, 29.84) in the mechanical prophylaxis group. During the investigational period, the incidence of all bleeding events was 9.5% in the darexaban 15 mg bid group and 3.9% in the mechanical prophylaxis group. In the darexaban 15 mg bid group, one patient experienced major bleeding and five patients experienced clinically relevant non-major (CRNM) bleeding. No patients in the mechanical prophylaxis group experienced major and/or CRNM bleeding. AEs were reported in 71.4% of patients in the darexaban 15mg bid group and 76.5% of patients in the mechanical prophylaxis group; the most frequent AEs across both treatment groups were constipation and insomnia. No patients died during the study.
Conclusions:
Based on these findings, darexaban is expected to be effective for the prevention of VTE in patients undergoing major abdominal surgery. (
Clinical Trial Registration Number:
NCT00942435).
Insights
Darexaban effectively prevented venous thromboembolism (VTE) in Japanese patients after major abdominal surgery, showing a lower incidence compared to mechanical prophylaxis. Safety profiles were comparable, with fewer bleeding events in the mechanical prophylaxis group.
Area of Science:
- Pharmacology
- Clinical Medicine
- Thrombosis Research
Background:
- Darexaban (YM150) is an oral direct factor Xa inhibitor.
- Investigated for venous thromboembolism (VTE) prophylaxis post-orthopaedic surgery.
- This study assessed darexaban in Japanese patients undergoing major abdominal surgery.
Purpose of the Study:
- To evaluate the efficacy and safety of darexaban 15 mg twice daily (bid).
- Compared darexaban against mechanical prophylaxis.
- Focused on VTE prevention in major abdominal surgery patients.
Main Methods:
- Phase III, multicentre, randomized, open-label study.
- Adult patients (≥ 40 years) received darexaban 15 mg bid or mechanical prophylaxis for 28 days.
- Primary endpoint: VTE incidence at Day 12; safety assessed via adverse and bleeding events.
Main Results:
- VTE incidence at Day 12 was 2.6% with darexaban vs. 15.0% with mechanical prophylaxis.
- All bleeding events occurred in 9.5% of darexaban patients versus 3.9% in the mechanical prophylaxis group.
- No deaths reported; common adverse events included constipation and insomnia.
Conclusions:
- Darexaban demonstrates efficacy in preventing VTE for patients undergoing major abdominal surgery.
- The drug is a potential therapeutic option for VTE prophylaxis in this patient population.
- Further research may explore optimizing safety profiles.
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