Findings from a study published in the British Journal of Clinical Pharmacology showed that apixaban appeared to be an appropriate alternative to warfarin for patients with severe renal impairment.
Apixaban, a Factor Xa inhibitor, was approved by the Food and Drug Administration (FDA) for use in patients with a creatinine clearance (CrCl) <15mL/min or those on dialysis based on pharmacokinetic data; the clinical trials did not include patients with CrCl <25mL/min or serum creatinine concentration (SCr) >2.5mg/dL. Researchers aimed to evaluate the safety and efficacy of apixaban vs. warfarin in this patient population through a retrospective, matched cohort study.
The study included 146 adults who were administered ≥1 dose of apixaban or warfarin while hospitalized between January 30, 2014 and December 31, 2015. Patients had a CrCl <25mL/min or SCr >2.5mg/dL, or received peritoneal dialysis or hemodialysis. Patients receiving warfarin with a therapeutic INR on admission were matched consecutively 1:1 in chronologic order to patients taking apixaban based on renal function and indication for anticoagulation.
The study’s primary outcome was major bleeding; secondary outcomes included composite of bleeding and documented ischemic stroke or recurrent venous thromboembolism. Study authors observed a nonsignificant difference in the incidence of major bleeding (9.6% vs. 17.8%; P=0.149) and composite bleeding (21.9% vs. 27.4%; P=0.442) between apixaban-treated patients vs. warfarin-treated patients, respectively. Also, the incidence of stroke was similar between the two groups (7.5% each).
No recurrent venous thromboembolism events were seen in either cohort during the study period.
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