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Effects of renal impairment on the pharmacokinetics, pharmacodynamics and safety of rivaroxaban, an oral, direct Factor Xa inhibitor

British Journal of Clinical Pharmacology · 2010 · Vol. 70(5) · pp. 703–712

Dagmar Kubitza✉(Bayer (Germany))Michael Becka(Bayer (Germany))Wolfgang Mueck(Bayer (Germany))Atef Halabi(Clinical Research Center Kiel)Haidar Maatouk(Clinical Research Center Kiel)Norbert Klause(Nephrologisches Zentrum Emsland)Volkmar Lufft(Nephrologisches Zentrum Emsland)Dominic D. Wand(University of Duisburg-Essen)Thomas Philipp(University of Duisburg-Essen)Heike Bruck(University of Duisburg-Essen)

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Abstract

Rivaroxaban clearance is decreased with increasing renal impairment, leading to increased plasma exposure and pharmacodynamic effects, as expected for a partially renally excreted drug. However, the influence of renal function on rivaroxaban clearance was moderate, even in subjects with severe renal impairment.

Atrial Fibrillation Management and Outcomes Venous Thromboembolism Diagnosis and Management Blood Coagulation and Thrombosis MechanismsRivaroxabanMedicinePharmacokineticsPharmacodynamicsRenal functionArea under the curvePharmacologyUrologyCreatinineInternal medicine

MeSH terms

RivaroxabanAdministration, OralAdultAgedCreatinineFemaleHalf-LifeHumansMaleMetabolic Clearance RateMiddle AgedMorpholinesThiophenesCohort StudiesArea Under Curve

Citations

428

FWCI

20.57

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