Content area
Full text
Published online: 16 January 2014
© Springer International Publishing Switzerland 2014
Abstract Rivaroxaban (Xarelto®), an oral direct factor Xa inhibitor, is approved for the initial treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as the prevention of recurrent DVT and PE. It is administered at a fixed oral dose and does not require routine coagulation monitoring. In the EINSTEIN-DVT and EINSTEIN-PE trials, in over 8,000 patients with DVT and/or PE, a single-drug approach with rivaroxaban was shown to be noninferior to standard therapy consisting of subcutaneous enoxaparin sodium overlapping with and followed by an oral dose-adjusted vitamin K antagonist (enoxaparin-VKA) with regard to the incidence of symptomatic recurrent venous thromboembolism (VTE) after 3, 6 or 12 months of treatment. Rivaroxaban was generally well tolerated in patients with DVT or PE, with no significant between-group differences in clinically relevant bleeding between the rivaroxaban and enoxaparin-VKA groups. Notably, rivaroxaban was associated with a significantly lower rate of major bleeding compared with enoxaparin-VKA when EINSTEIN-DVT and EINSTEIN-PE data were pooled. Pharmacoeconomic analyses indicated that rivaroxaban may be a cost-effective alternative to enoxaparin-VKA for the treatment of DVT or PE and prevention of recurrent VTE. Extended prophylaxis with rivaroxaban reduced the incidence of symptomatic recurrent VTE to a greater extent than placebo in the EINSTEIN-Extension trial, but was associated with a non-significant increase in the risk of clinically relevant bleeding compared with placebo. In conclusion, rivaroxaban is a reasonable alternative to standard therapy for the treatment of DVT and PE, and as extended thromboprophylaxis.
1 Introduction
Venous thromboembolism (VTE), a general term that refers to deep vein thrombosis (DVT) and pulmonary embolism (PE) [1], is a common cause of morbidity and mortality worldwide, particularly in hospitalized and recently discharged patients [1, 2]. DVT commonly occurs in the deep veins of the legs and can become a potentially fatal PE if the thrombus dislodges and travels to the lungs [1, 3]. In the EU, the estimated number of DVT events was 148 per 100,000 person-years and the estimated number of PE events was 95 per 100,000 person-years in an epide- miological model study [4]. In the US, an estimated 300,000-600,000 individuals are affected by VTE each year [5].
The burden of VTE often extends beyond...