Xarelto (varoxaban, a factor Xa inhibitor) is the first oral anti-coagulant approved for anti-coagulation in 60 years, since Warfarin (coumadin) was approved. A variety of parenteral options are available; however, the oral route is preferred by many physicains and patients. In November 2012, the U.S. Food and Drug Administration expanded the approved use of Xarelto (rivaroxaban) to include treating deep vein thrombosis (DVT) or pulmonary embolism (PE), and to reduce the risk of recurrent DVT and PE following initial treatment. Previously Xarelto was only approved for Reduction of Risk of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation.
The approval was approved based on three clinical studies. A total of 9,478 patients with DVT or PE were randomly assigned to receive Xarelto, a combination of enoxaparin and a vitamin K antagonist (VKA, Coumadin)), or a placebo. The studies ‘ end-point was the number of patients who experienced recurrent DVT, PE or death after receiving treatment.
Results showed Xarelto was as effective as the enoxaparin and VKA combination for treating DVT and PE. About 2.1 percent of patients treated with Xarelto compared with 1.8 percent to 3 percent of patients treated with the enoxaparin and VKA combination experienced a recurrent DVT or PE. Additionally, results from a third study showed extended Xarelto treatment reduced the risk of recurrent DVT and PE in patients. About 1.3 percent of patients treated with Xarelto compared with 7.1 percent of patients receiving placebo experienced a recurrent DVT or PE. With this results, when oral preparations are preferred for treatment of DVT or PE, Xarelto appears to have an advantage over par-enteral anticoagulants.
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