Key result
Apixaban in ESRD yields ~36% higher AUC versus healthy subjects, with limited clearance during hemodialysis.
Why the study?
How do the pharmacokinetics, pharmacodynamics, and safety of a single 5-mg dose of apixaban compare between subjects with ESRD on hemodialysis and healthy subjects?
Population
16 subjects: 8 with end-stage renal disease on hemodialysis and 8 healthy subjects with normal renal function.
Comparison
Single oral 5-mg dose of apixaban. vs Single oral 5-mg dose of apixaban administered…
Design
Cohort, open-label
Authors
Loading...
May support 5-mg apixaban dosing in ESRD on HD; extends PK data but leaves open outcome trials.
How do the pharmacokinetics, pharmacodynamics, and safety of a single 5-mg dose of apixaban compare between subjects with ESRD on hemodialysis and healthy subjects?
In subjects with ESRD on hemodialysis, a single 5-mg dose of apixaban results in a modest increase in exposure (AUC) without an increase in Cmax, and hemodialysis has limited impact on its clearance.
Wang et al. (2015) studied End-stage renal disease on hemodialysis (n=16). Apixaban vs. Healthy subjects with normal renal function was evaluated on Pharmacokinetics (Cmax, AUCinf), pharmacodynamics, and safety. A single 5-mg dose of apixaban in subjects with ESRD resulted in a 36% higher AUCinf and 10% lower Cmax compared with healthy subjects, and hemodialysis had limited impact on clearance.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: