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James A. Reiffel, MD - Novel Oral Anticoagulants - Figure 28

Rivaroxaban: Indication

RIVAROXABAN

Rivaroxaban (Xarelto; Janssen Pharmaceuticals) is the second of the novel oral anticoagulants to be approved in the United States and the first in this new class of anticoagulants, the factor Xa inhibitors.  In its regulatory approval rivaroxaban is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular AFib (the same indication as for dabigatran)  The rivaroxaban label specifically states that there are limited data on the relative effectiveness of rivaroxaban compared to nd warfarin in reducing the risk when warfarin therapy is well controlled [112]; however, this caveat occurs because the definition of the TTR for warfarin in the pivotal trial of this new agent, ROCKET AF, was modest [97]as discussed below. 

 Reiffel JA. Am J Med 2013; 126: 00-00.

Complete references for all slides

References

[97] Patel MR, Mahaffey KW, Garg J, et al; the ROCKET AF Steering Committee, for the ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365:883-891.

[112] Xarelto® (rivaroxaban) film-coated oral tablets [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc; 2011. Revised: November 2012.

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