In this episode, I’ll discuss the efficacy tradeoff when reducing apixaban dose in patients with end-stage renal disease.
The prescribing information for apixaban recommends not reducing the dose when being used in patients with end-stage renal disease and atrial fibrillation. However, renal elimination accounts for 27% of apixaban clearance. This has led some clinicians to reducing the apixaban dose for ESRD patients to 2.5 mg po bid for prevention of stroke in patients with AFib.
A retrospective study published in Circulation that examined medicare claims data can shed some light on the potential effects of this dose reduction. The study was done to compare apixaban with warfarin, but apixaban patients were further analyzed based on dosage.
Apixaban and warfarin patients were matched in a 1:3 ratio from a cohort of over 25,000 patients. Study outcomes looked at the differences between groups in survival free of stroke or systemic embolism, major bleeding, gastrointestinal bleeding, intracranial bleeding, and death.
In the matched cohorts, there was similar efficacy and less bleeding for the apixaban group when compared with the warfarin group.
However, when apixaban 5 mg po bid was compared with 2.5 mg po bid, the higher dose was associated with significantly lower risks of stroke/systemic embolism and death as compared with reduced-dose apixaban. This was a statistically significant difference for reduced risk of stroke/systemic embolism and death in favor of the 5 mg po bid dose of apixaban.
Prospective studies looking at apixaban in ESRD patients are underway but have yet to be published. Until then, studies like this one and meta-analysis of other observational cohort studies form the basis for the apixaban prescribing information’s recommendation to not reduce the dose when treating patients with AFib and ESRD.
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