Abstract

Background Rivaroxaban is the first oral anticoagulant drug that is a direct inhibitor of activated factor X (FXa) of clotting which may provide a simple, fixed-dose regimen for treating acute deep-vein thrombosis (DVT) without the need for laboratory monitoring. Method An opened label randomized parallel group clinical trial compared subcutaneous enoxaparin 1 mg/ kg once daily for 5 days followed by oral rivaroxaban 20 mg once daily with subcutaneous enoxaparin 1 mg/ kg once daily followed by a vitamin K antagonist (warfarin) for 2 month of treatment. The primary efficacy outcome for both was recurrent venous thromboembolism (VTE). The principal safety outcome was major bleeding or clinically relevant non major bleeding. Results Out of the 20 patients in the rivaroxaban group, 5 patients (25%) developed bleeding events while in the standard therapy group 8 out of 20 patients, 40 % developed bleeding events. Moreover, 10 patients in the rivaroxaban group (50%) developed adverse drug reactions versus 14 patients (70%) in the standard therapy group. However, none of the patients in both groups developed recurrent VTE neither DVT nor pulmonary embolism (PE).

Highlights

  • Deep vein thrombosis (DVT) and acute pulmonary embolism (PE) are two manifestations of the same disorder, venous thromboembolism (VTE)

  • Enoxaparin at dose of 1 mg/ kg followed by rivaroxaban at a dose of 20 mg once daily is effective, safe and well tolerated drug treatment option for patients with deep-vein thrombosis (DVT)

  • The present study shows that rivaroxaban is as effective as standard therapy, with similar safety, for the treatment of acute DVT

Read more

Summary

Introduction

Deep vein thrombosis (DVT) and acute pulmonary embolism (PE) are two manifestations of the same disorder, venous thromboembolism (VTE). Even in the absence of pulmonary embolism (PE), DVT may cause significant morbidity resulting from chronic swelling, ulceration, debilitating pain, and future risk of recurrent DVT and PE (Hirsh and Hoak, 1996). Post-phlebitic syndrome can occur after a deep vein thrombosis (the affected leg can become chronically swollen and painful with skin color changes and ulcer formation around the foot and ankle) (Kahn and Ginsberg, 2004). Rivaroxaban is the first oral anticoagulant drug that is a direct inhibitor of activated factor X (FXa) of clotting which may provide a simple, fixed-dose regimen for treating acute deep-vein thrombosis (DVT) without the need for laboratory monitoring

Objectives
Methods
Discussion
Conclusion
Full Text
Published version (Free)

Talk to us

Join us for a 30 min session where you can share your feedback and ask us any queries you have

Schedule a call