Why the study?
Does hepatic impairment affect the pharmacokinetics and pharmacodynamics of a single 10 mg dose of rivaroxaban?
Does hepatic impairment affect the pharmacokinetics and pharmacodynamics of a single 10 mg dose of rivaroxaban?
Moderate hepatic impairment significantly increases rivaroxaban exposure and pharmacodynamic effects after a single 10 mg dose, whereas mild impairment does not.
May warrant caution with rivaroxaban in moderate hepatic impairment; leaves open need for outcome trials.
Moderate (but not mild) hepatic impairment reduced total body clearance of rivaroxaban after a single 10 mg dose, leading to increased rivaroxaban exposure and pharmacodynamic effects.
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Kubitza et al. (2013) studied this question.
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