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James A. Reiffel, MD - Novel Oral Anticoagulants - Figure 30

Once-daily dosing with Rivaroxaban

The Figure shows the pharmacologic profile versus time for escalating doses of rivaroxaban in a randomized, single-blind, placebo controlled study.[114] The black line in the Figure is the placebo, and it lies just along the line of 0 inhibition of factor Xa. At its lowest dose, 5 mg (orange line), rivaroxaban’s inhibition of factor Xa falls to approximately the same as placebo by 12 hours; however, at the higher doses of rivaroxaban the factor Xa inhibition is still in the effective range out to 24 hours, and therefore the second-highest dose, 20 mg, was chosen for assessment in the pivotal Phase 3 trial of rivaroxaban, ROCKET AF.

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

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References

[114] Kubitza D, Becka M, Voith B, Zuehlsdorf M, Wensing G. Safety, pharmacodynamics, and pharmacokinetics of single doses of BAY 59-7939, an oral, direct factor Xa inhibitor. Clin Pharmacol Ther. 2005;78:412-421.