Associations of Apixaban Dose With Safety and Effectiveness Outcomes in Patients With Atrial Fibrillation and Severe Chronic Kidney Disease

Retrospective cohort study of patients with atrial fibrillation and CKD stage 4/5 found use of apixaban 5mg, when compared to 2.5mg, was associated with a higher risk of bleeding (incidence rate 4.9 versus 2.9 events per 100 person-years; HR 1.63 [95% CI 1.04–2.54]).

SPS commentary:

There was no evidence of any difference between apixaban 5mg and 2.5mg dosing in terms of the risk of stroke/systemic embolism (3.3 versus 3.0 events per 100 person-years; HR 1.01 [95% CI 0.59–1.73]) or death (9.9 versus 9.4 events per 100 person-years; HR 1.03 [0.77–1.38]).

For the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and severe renal impairment (creatinine clearance 15-29 mL/min), the UK SPC recommends the lower dose of 2.5mg twice daily.

The authors say their findings support the KDIGO guideline dosing recommendations for this population and apixaban dosing recommendations based on kidney function as used in Europe, which differ from those issued by the FDA, which are based on serum creatinine and often lead to prescription of a 5mg twice daily dose in this population

Circulation