Safety outcomes of apixaban in patients with nonvalvular atrial fibrillation and severe renal impairment.

Abstract

Apixaban is prescribed for stroke prevention in nonvalvular atrial fibrillation (NVAF) in patients with varying degrees of renal dysfunction. While pharmacokinetic data support apixaban in severe renal impairment, clinical safety outcomes data are limited. This retrospective cohort analysis was conducted to evaluate the safety of apixaban in patients with NVAF and renal impairment. A total of 340 patients with NVAF receiving apixaban 5mg or 2.5mg twice daily were included for analysis; 287 preserved renal function (pRF: CrCl ≥ 25ml/min and SCr ≤ 2.5mg/dl) and 53 impaired renal function (iRF: CrCl < 25ml/min and/or SCr > 2.5mg/dl). The primary endpoint was major bleeding in patients taking apixaban 5mg. Secondary endpoints included major bleeding with apixaban 2.5mg and minor bleeding in both groups. There was no difference in major bleeding events in the 5mg pRF group (4.41%) versus iRF group (3.57%) (P = 0.66). Similar rates occurred between the 2.5mg pRF and iRF groups. Minor bleeding events were similar regardless of renal function. The incidence of bleeding in the 5mg group was 11.45% with pRF versus 10.71% with iRF (P = 0.6). In the 2.5mg group, bleeding incidence was 10% with pRF versus 16% with iRF (P = 0.47). There were no observed differences in bleeding between groups with pRF or iRF, regardless of apixaban dose. Because patients with severe renal impairment were excluded from original trials, this study contributes clinical safety outcomes to the limited data for use of apixaban in this patient population.