EFFICACY AND SAFETY OUTCOMES OF RIVAROXABAN IN ACUTE DEEP VENOUS THROMBOSIS PATIENTS

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).