Key result
Apixaban 2.5 mg twice-daily is linked to ~31% higher levels vs once-daily in hemodialysis without accumulation.
Why the study?
Inconsistent study results and contradictory recommendations from health authorities regarding apixaban use in hemodialysis patients have created clinical uncertainty, making investigations of appropriate dosing an unmet need.
Does apixaban 2.5 mg once or twice daily in hemodialysis patients achieve appropriate drug levels compared to non-CKD populations, and do these levels correlate with bleeding?
Observational (n=24)
No
Does apixaban 2.5 mg once or twice daily in hemodialysis patients achieve appropriate drug levels compared to non-CKD populations, and do these levels correlate with bleeding?
Absolute Event Rate: 71.3% vs 54.4%
p-value: p=<0.001
In hemodialysis patients, higher pre-dialysis apixaban levels and concomitant antiplatelet therapy are associated with increased bleeding risk, suggesting a potential role for drug level monitoring.
Higher apixaban levels and antiplatelet use were associated with bleeding in hemodialysis; supports monitoring hypothesis but remains hypothesis-generating.
BACKGROUND: Inconsistent study results and contradictory recommendations from health authorities regarding the use of apixaban in patients on hemodialysis have generated considerable uncertainty among clinicians, making investigations of appropriate dosing an unmet need. METHODS: We analyzed pre-dialysis apixaban drug levels from a tertiary care dialysis unit, comparing 2.5 mg once versus twice daily dosing. We applied mixed-effects models including dialysis modality, adjusted standard Kt/V, ultrafiltration, and dialyzer characteristics. We included an exploratory analysis of bleeding events and compared the drug levels of our dialysis patients to those from non-CKD reference populations taking the standard dose of 5 mg twice daily. RESULTS: percentile of drug levels did not exceed those of non-CKD populations taking 5 mg twice daily. Median (IQR) drug levels before a bleeding (8 episodes) were higher than those without a subsequent bleeding: 111.6 (83.1 - 129.3) versus 54.8 (< 40 - 77.1) ng/mL (P < 0.001). Concomitant antiplatelet therapy was used in 86% of those with bleeding events versus 6% without bleeding events (P < 0.001). CONCLUSIONS: percentiles of reference populations) may improve decision-making in highly individualized risk-benefit analyses.
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Schietzel et al. (2024) conducted an observational in Chronic hemodialysis requiring apixaban (n=24). Apixaban vs. Apixaban 2.5 mg once daily was evaluated on Median apixaban drug levels (ng/mL) (p=<0.001). Apixaban 2.5 mg twice daily resulted in significantly higher median drug levels compared to 2.5 mg once daily (71.3 vs 54.4 ng/mL, P<0.001) in hemodialysis patients, without signs of accumulation.
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