Key result
Phase III studies demonstrated that rivaroxaban and dabigatran were noninferior to standard treatment for venous thromboembolism treatment, with similar rates of bleeding.
Why the study?
Do new oral anticoagulants (anti-Xa and thrombin inhibitors) effectively prevent and treat venous thromboembolism compared to standard treatment?
Do new oral anticoagulants (anti-Xa and thrombin inhibitors) effectively prevent and treat venous thromboembolism compared to standard treatment?
New oral anticoagulants, including anti-Xa and thrombin inhibitors, offer a non-inferior alternative to standard treatment for the prevention and treatment of VTE with a similar bleeding profile.
Several oral direct anti-Xa agents and one antithrombin agent are currently under clinical development for the prevention and treatment of venous thromboembolism (VTE). The anti-Xa inhibitors rivaroxaban (10 mg once daily) and apixaban (2.5 mg twice daily) as well as the thrombin inhibitor dabigatran (150 or 220 mg once daily) have been recently licensed for the prevention of VTE in total hip or knee replacement. The publication of the results of studies with rivaroxaban and apixaban in the prevention of VTE in medical patients are awaited. Phase III studies on the treatment of VTE showed the non inferiority of rivaroxaban (15 mg twice daily in the first three weeks and 20 mg once daily thereafter) and dabigatran (150 mg twice daily) to standard treatment. The incidence of major or clinically relevant non-major bleeding was similar in patients receiving standard treatment and rivaroxaban or dabigatran. Clinical trials on VTE treatment are currently ongoing with apixaban and edoxaban. A number of phase II clinical trials are currently ongoing with several other antiXa agents in the prophylaxis and treatment of VTE.
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Becattini et al. (2012) conducted a review in Venous Thromboembolism. Oral direct anti-Xa agents and thrombin inhibitors vs. Standard treatment was evaluated on Venous thromboembolism and bleeding. Phase III studies demonstrated that rivaroxaban and dabigatran were noninferior to standard treatment for venous thromboembolism treatment, with similar rates of bleeding.
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