Table 2.

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

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)‡

*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].

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.