Key result
Unapproved apixaban regimens affect 18% of nonvalvular AF patients, driven primarily by underdosing.
Why the study?
Apixaban is approved for stroke prevention in nonvalvular atrial fibrillation, but dosing and safety in a community hospital setting require characterization and evaluation.
What are the prescribing patterns and safety outcomes of apixaban for nonvalvular atrial fibrillation in a community hospital setting?
Observational (n=707)
No
What are the prescribing patterns and safety outcomes of apixaban for nonvalvular atrial fibrillation in a community hospital setting?
A significant proportion of patients receiving apixaban for atrial fibrillation in a community hospital are underdosed, highlighting the need for monitoring to ensure adherence to FDA-approved regimens.
Supports monitoring for appropriate apixaban dosing in community hospitals; hypothesis-generating for safety implications in nonvalvular AF.
Background: Apixaban, a direct factor Xa inhibitor, is approved by the US Food and Drug Administration (FDA) for prevention of stroke and systemic embolism in nonvalvular atrial fibrillation. Apixaban’s compelling safety and efficacy data, combined with minimal laboratory monitoring, make it an attractive anticoagulant. Objectives: To characterize and evaluate the dosing and safety of apixaban for the treatment of nonvalvular atrial fibrillation at a community hospital. Design/Patients: A retrospective chart review evaluated patients ≥18 years of age who received at least 2 consecutive doses of apixaban from January 1, 2013 to June 30, 2016. Patients with multiple admissions were evaluated for each hospitalization. Patients were excluded if height, weight, or serum creatinine was not documented during hospital admission. Patients who received apixaban for the treatment or prophylaxis of venous thromboembolism were excluded. Prescribing patterns were characterized based on FDA-approved dosing regimens and patient demographics. Safety outcomes included incidences of major, clinically relevant nonmajor, and minor bleeding. Results: Of the 707 patients evaluated, 82% received an FDA-approved apixaban regimen. Of the 127 patients (18%) who received an unapproved regimen, 5.5% (7 patients) received an unapproved frequency and 94.5% (120 patients) received an unapproved dose. The majority (98 patients, 81.7%) were underdosed. Composite bleeding rates were 2.7%, with 1.8% major bleeds, 0.7% clinically relevant nonmajor bleeds, and 0.1% minor bleeds. Conclusions: The use of apixaban must be monitored in order to ensure FDA-approved dosing regimens are being prescribed and patients are not being underdosed.
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Tellor et al. (2017) conducted an observational in nonvalvular atrial fibrillation (n=707). Apixaban was evaluated on Receipt of an FDA-approved apixaban regimen. Among patients receiving apixaban for nonvalvular atrial fibrillation, 18% received an unapproved regimen, with 81.7% of those patients being underdosed.
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