Why the study?
Does a single 15-mg dose of rivaroxaban have a comparable pharmacokinetic and pharmacodynamic profile in ESRD patients on hemodialysis compared to healthy controls?
Population
16 subjects: 8 with end-stage renal disease clinically stable on maintenance hemodialysis for ≥3 months, and…
Comparison
Single 15-mg dose of rivaroxaban administered 2… vs Healthy control subjects receiving a single…
Design
Cohort, open-label
Authors
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May warrant dosing caution in ESRD on hemodialysis; leaves open need for outcome trials before practice change.
Does a single 15-mg dose of rivaroxaban have a comparable pharmacokinetic and pharmacodynamic profile in ESRD patients on hemodialysis compared to healthy controls?
A 15-mg dose of rivaroxaban in chronic hemodialysis patients shows comparable PK/PD changes to those seen in moderate-to-severe renal impairment, with minimal drug clearance impact from the dialysis procedure itself.
Dias et al. (2016) studied this question.
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