Safety of Edoxaban 30 mg in Elderly Patients with Severe Renal Impairment

Clin Drug Investig. 2018 Nov;38(11):1023-1030. doi: 10.1007/s40261-018-0693-6.


Background and objective: Patients with atrial fibrillation (AF) and advanced chronic kidney disease (CKD) are at high risk of adverse events and are complicated to manage. There is little evidence on the effects of non-vitamin K oral anticoagulants in patients with severe CKD. Preliminary data in patients taking edoxaban whose creatinine clearance fell below 30 mL/min showed a low risk of stroke and major bleeding. The aim of our study is to test the safety of edoxaban 30 mg/day in patients with severe renal impairment with an estimated glomerular filtration rate (eGFR) of 15-29 mL/min.

Methods: We analyzed retrospective data from 46 patients who had documented AF with severe renal impairment (eGFR between 15 and 29 mL/min). The follow-up, characterized by clinical examination and blood analysis, was performed at 3, 6, and 12 months. The main endpoint was the incidence of major bleedings or clinically relevant non-major (CRNM) bleedings or thromboembolic events.

Results: At the time of the data collection, the average follow-up was 9.13 ± 3.0 months. There were no major bleedings, strokes, systemic embolisms, or cardiovascular deaths reported: one non-cardiac death and five minor hemorrhages occurred. No differences related to the severity of CKD were observed in the left ventricular ejection fraction at echocardiography and in the thrombotic and hemorrhagic risk profile.

Conclusion: In this explorative study analyzing patients with severe CKD treated with edoxaban 30 mg once daily, no major bleeding or thrombotic events were observed. Some minor bleedings were observed. While additional studies are necessary to confirm the results of this exploratory study, edoxaban 30 mg once daily appears to be safe in patients with severe CKD.

Publication types

  • Multicenter Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Factor Xa Inhibitors / administration & dosage*
  • Factor Xa Inhibitors / adverse effects
  • Factor Xa Inhibitors / therapeutic use
  • Female
  • Follow-Up Studies
  • Glomerular Filtration Rate / drug effects*
  • Glomerular Filtration Rate / physiology
  • Hemorrhage / chemically induced
  • Humans
  • Male
  • Pyridines / administration & dosage*
  • Pyridines / adverse effects
  • Registries
  • Renal Insufficiency, Chronic / diagnosis*
  • Renal Insufficiency, Chronic / drug therapy*
  • Renal Insufficiency, Chronic / physiopathology
  • Retrospective Studies
  • Severity of Illness Index*
  • Stroke / chemically induced
  • Thiazoles / administration & dosage*
  • Thiazoles / adverse effects


  • Factor Xa Inhibitors
  • Pyridines
  • Thiazoles
  • edoxaban