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Table 2 Rivaroxaban plasma concentrations after therapeutic doses based on phase II data and simulated virtual data

From: Laboratory assessment of rivaroxaban: a review

Dose

Clinical setting

Ctrough(μg/l)

Cmax(μg/l)

2.5 mg bid

Acute coronary syndrome

16 (6–34)*

44 (28–66)*

10 mg od

VTE prevention after total hip replacement

9 (1–38)#

125 (91–196)#

15 mg od

Stroke prevention in patients with AF (CrCl ≤50 ml/min)

57 (18–136)

229 (178–313)

20 mg od

DVT treatment (continued treatment)

26 (6–87)§

270 (189–419)§

20 mg od

Stroke prevention in patients with AF (CrCl >50 ml/min)

44 (12–137)

249 (184–343)

  1. *Estimated parameters at steady state – median values (5th–95th percentile range) [18]. #Estimated parameters at steady state – median values (5th–95th percentile range) in patients undergoing hip replacement surgery [46]. Estimated parameters at steady state – geometric means (5th–95th percentile range) in stroke prevention in patients with AF (Bayer HealthCare Pharmaceuticals and Janssen Research & Development, LLC: data on file). §Estimated parameters at steady state – geometric means (5th–95th percentile range) in phase II studies in the acute treatment of DVT [19].
  2. Abbreviations: AF atrial fibrillation, bid: twice daily, C max maximum plasma concentration, CrCl creatinine clearance, C trough minimum plasma concentration, DVT deep vein thrombosis, od once daily, VTE venous thromboembolism.