title: Comparison of the Safety and Effectiveness of Apixaban versus Warfarin in Patients with Severe Renal Impairment.
abstract: OBJECTIVE
  The U.S. Food and Drug Administration approval of the use of apixaban in patients with a creatinine clearance (CrCl) of < 15 ml/minute or in those receiving dialysis is based only on pharmacokinetic data as clinical trials of apixaban excluded patients with a CrCl of < 25 ml/minute or a serum creatinine concentration (SCr) of > 2.5 mg/dl. Thus, the objective of this study was to evaluate the safety and effectiveness of apixaban versus warfarin in patients with severe renal impairment.
  
  
  METHODS
  Retrospective, matched-cohort study.
  
  
  METHODS
  Community hospital.
  
  
  METHODS
  A total of 146 adults who received at least one dose of apixaban (73 patients) or warfarin (73 patients) while hospitalized between January 30, 2014, and December 31, 2015, and had a CrCl of < 25 ml/minute or SCr of > 2.5 mg/dl, or who received peritoneal dialysis or hemodialysis, were included. Patients who were taking warfarin and had a therapeutic international normalized ratio on admission were matched consecutively in a 1:1 fashion in chronologic order to patients taking apixaban based on renal function and indication for anticoagulation.
  
  
  RESULTS
  The primary outcome was major bleeding. Secondary outcomes included the composite of bleeding (major bleeding, clinically relevant nonmajor bleeding, and minor bleeding) in addition to documented ischemic stroke or recurrent venous thromboembolism. A nonsignificant difference in the occurrence of major bleeding and composite bleeding was observed between patients who received apixaban compared with those who received warfarin (9.6% vs 17.8%, p=0.149, and 21.9% vs 27.4%, p=0.442, respectively). The occurrence of stroke was similar between the groups (7.5% in each group), and no recurrent venous thromboembolism events were noted in either group during the study period.
  
  
  CONCLUSIONS
  Apixaban appears to be a reasonable alternative to warfarin in patients with severe renal impairment.
authors.affiliation: Missouri Baptist Medical Center, St. Louis, Missouri.
authors.forename: Brooke E
authors.initials: BE
authors.lastname: Stanton
authors.affiliation: Missouri Baptist Medical Center, St. Louis, Missouri.
authors.forename: Naomi S
authors.initials: NS
authors.lastname: Barasch
authors.affiliation: Department of Pharmacy Practice, St. Louis College of Pharmacy, St. Louis, Missouri.
authors.forename: Katie B
authors.initials: KB
authors.lastname: Tellor
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D015331:Cohort Studies; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced / Q000453:epidemiology; D006764:Hospitals, Community; D006801:Humans; D008297:Male; D010530:Peritoneal Dialysis; D011720:Pyrazoles / Q000009:adverse effects / Q000627:therapeutic use*; D011728:Pyridones / Q000009:adverse effects / Q000627:therapeutic use*; D006435:Renal Dialysis; D051437:Renal Insufficiency / Q000150:complications* / Q000503:physiopathology / Q000628:therapy; D012189:Retrospective Studies; D020521:Stroke / Q000453:epidemiology / Q000517:prevention & control; D016896:Treatment Outcome; D054556:Venous Thromboembolism / Q000453:epidemiology / Q000517:prevention & control; D014859:Warfarin / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000925:Anticoagulants; D011720:Pyrazoles; D011728:Pyridones; C522181:apixaban; D014859:Warfarin
keywords: anticoagulation; cardiology; dialysis; end-stage renal disease; renal failure