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| Safety and Efficacy of Apixaban in Patients Receiving Hemodialysis Compared to Patients with Moderate Renal Dysfunction |
| Denise Sutter-Long, Anisa Bici, Erin Mouland, Liza Renner, Nghi Ha Michigan Medicine, Ann Arbor, MI, United States |
Introduction Apixaban is FDA approved for use in patients with end stage renal disease (ESRD). Patients with ESRD were excluded from the phase three clinical trials, therefore dosing is based on single-dose pharmacokinetic and pharmacodynamic studies and extrapolated to be similar results to patients with moderate renal dysfunction (CrCl 30-50 mL/min). This study aims to determine if the safety and efficacy of apixaban in patients on dialysis is similar to patients with moderate renal dysfunction. Methods This study was a single-center, retrospective chart review. Adults on dialysis or with moderate renal function taking apixaban for atrial fibrillation (AF) or venous thromboembolism (VTE) were included in the study. Patients were matched based on age, sex, indication, and apixaban dose. The primary efficacy outcome was a composite incidence of stroke (CVA), transient ischemic attack (TIA), and VTE. The primary safety outcome was incidence of major bleeding. Results The study cohorts included 38 patients each. There was no significant difference in safety and efficacy outcomes between groups. When accounting for potential confounders such as age, BMI, history of comorbidities, and drug dosing, dialysis status increased the risk for experiencing a CVA or developing a VTE (HR 1.14 (95% CI 1.04-1.24), p = 0.004). Conclusion Dialysis status is a significant risk factor for CVA and VTE. Major bleeding events are likely not affected by dialysis. Larger studies are needed to further validate if dialysis patients taking apixaban will have safety and efficacy outcomes comparable to patients with moderate renal dysfunction. |