%0 Generic
%A C., Dias
%A K.T., Moore
%A J., Murphy
%A J., Ariyawansa
%A W., Smith
%A R.M., Mills
%A M.R., Weir
%D 2017
%T Erratum: Pharmacokinetics, Pharmacodynamics, and Safety of Single-Dose Rivaroxaban in Chronic Hemodialysis
%U https://karger.figshare.com/articles/dataset/Erratum_Pharmacokinetics_Pharmacodynamics_and_Safety_of_Single-Dose_Rivaroxaban_in_Chronic_Hemodialysis/5241970
%R 10.6084/m9.figshare.5241970.v1
%2 https://karger.figshare.com/ndownloader/files/8956711
%K Anticoagulant
%K Factor Xa inhibitor
%K Rivaroxaban
%K End-stage renal disease
%K Hemodialysis
%K Pharmacokinetics
%K Pharmacodynamics
%X Background: This study aimed to characterize the single-dose pharmacokinetic (PK) and pharmacodynamic (PD) profile of rivaroxaban 15 mg administered before and after dialysis in subjects with end-stage renal disease (ESRD), and to compare this profile in subjects with ESRD to that in healthy control subjects (creatinine clearance ≥80 ml/min). Methods: This was an open-label, single-dose, single-center, parallel-group study of rivaroxaban in ESRD subjects who had been clinically stable on maintenance hemodialysis for ≥3 months. In 8 subjects with ESRD, a 15-mg dose of rivaroxaban was administered 2 ± 0.5 h before a hemodialysis session and repeated 7-14 days later at 3 h after a 4-h hemodialysis session. Eight healthy control subjects, matched for age, sex, and body mass index, received one 15-mg rivaroxaban dose. Results: Compared to healthy subjects, area under the rivaroxaban plasma concentration versus time curve (AUC) increased by 56% following post-dialysis administration. Assuming similar bioavailability between groups, this reflects an approximate 35% decrease in overall drug clearance in ESRD subjects. Pre-dialysis dosing resulted in only 5% lowering of AUC versus post-dialysis dosing, confirming the minimal impact of dialysis on the PK of rivaroxaban. PD effects, as assessed by change in prothrombin time, percent factor Xa inhibition, and anti-Xa activity, were generally concordant with observed changes in plasma PK. Conclusions: Changes in PK and PD parameters in chronic dialysis patients were generally comparable to changes observed previously in patients with moderate-to-severe renal impairment who were not undergoing dialysis, and support use of a 15-mg dose in this patient population.
%I Karger Publishers