title: Dabigatran and rivaroxaban use in atrial fibrillation patients on hemodialysis.
abstract: BACKGROUND
  Dabigatran and rivaroxaban are new oral anticoagulants that are eliminated through the kidneys. Their use in dialysis patients is discouraged because these drugs can bioaccumulate to precipitate inadvertent bleeding. We wanted to determine whether prescription of dabigatran or rivaroxaban was occurring in the dialysis population and whether these practices were safe.
  
  
  RESULTS
  Prevalence plots were used to describe the point prevalence (monthly) of dabigatran and rivaroxaban use among 29977 hemodialysis patients with atrial fibrillation. Poisson regression compared the rate of bleeding, stroke, and arterial embolism in patients who started dabigatran, rivaroxaban, or warfarin. The first record of dabigatran prescription among hemodialysis patients occurred 45 days after the drug became available in the United States. Since then, dabigatran and rivaroxaban use in the atrial fibrillation-end-stage renal disease population has steadily risen where 5.9% of anticoagulated dialysis patients are started on dabigatrian or rivaroxaban. In covariate adjusted Poisson regression, dabigatran (rate ratio, 1.48; 95% confidence interval, 1.21-1.81; P=0.0001) and rivaroxaban (rate ratio, 1.38; 95% confidence interval, 1.03-1.83; P=0.04) associated with a higher risk of hospitalization or death from bleeding when compared with warfarin. The risk of hemorrhagic death was even larger with dabigatran (rate ratio, 1.78; 95% confidence interval, 1.18-2.68; P=0.006) and rivaroxaban (rate ratio, 1.71; 95% confidence interval, 0.94-3.12; P=0.07) relative to warfarin. There were too few events in the study to detect meaningful differences in stroke and arterial embolism between the drug groups.
  
  
  CONCLUSIONS
  More dialysis patients are being started on dabigatran and rivaroxaban, even when their use is contraindicated and there are no studies to support that the benefits outweigh the risks of these drugs in end-stage renal disease.
authors.affiliation: From Nephrology Division, Massachusetts General Hospital, Waltham, MA (K.E.C., J.B.W., R.I.T.); Clinical Research Division, Fresenius Medical Care North America, Waltham, MA (K.E.C., F.W.M.); Massachusetts Institute of Technology, Harvard-MIT Biomedical Engineering Center, Institute for Medical Engineering and Science, Cambridge, MA (E.R.E.); and Cardiovascular Medicine Division, Brigham and Women's Hospital, Boston, MA (E.R.E.). kevin.chan@fmc-na.com.
authors.forename: Kevin E
authors.initials: KE
authors.lastname: Chan
authors.affiliation: From Nephrology Division, Massachusetts General Hospital, Waltham, MA (K.E.C., J.B.W., R.I.T.); Clinical Research Division, Fresenius Medical Care North America, Waltham, MA (K.E.C., F.W.M.); Massachusetts Institute of Technology, Harvard-MIT Biomedical Engineering Center, Institute for Medical Engineering and Science, Cambridge, MA (E.R.E.); and Cardiovascular Medicine Division, Brigham and Women's Hospital, Boston, MA (E.R.E.).
authors.forename: Elazer R
authors.initials: ER
authors.lastname: Edelman
authors.affiliation: From Nephrology Division, Massachusetts General Hospital, Waltham, MA (K.E.C., J.B.W., R.I.T.); Clinical Research Division, Fresenius Medical Care North America, Waltham, MA (K.E.C., F.W.M.); Massachusetts Institute of Technology, Harvard-MIT Biomedical Engineering Center, Institute for Medical Engineering and Science, Cambridge, MA (E.R.E.); and Cardiovascular Medicine Division, Brigham and Women's Hospital, Boston, MA (E.R.E.).
authors.forename: Julia B
authors.initials: JB
authors.lastname: Wenger
authors.affiliation: From Nephrology Division, Massachusetts General Hospital, Waltham, MA (K.E.C., J.B.W., R.I.T.); Clinical Research Division, Fresenius Medical Care North America, Waltham, MA (K.E.C., F.W.M.); Massachusetts Institute of Technology, Harvard-MIT Biomedical Engineering Center, Institute for Medical Engineering and Science, Cambridge, MA (E.R.E.); and Cardiovascular Medicine Division, Brigham and Women's Hospital, Boston, MA (E.R.E.).
authors.forename: Ravi I
authors.initials: RI
authors.lastname: Thadhani
authors.affiliation: From Nephrology Division, Massachusetts General Hospital, Waltham, MA (K.E.C., J.B.W., R.I.T.); Clinical Research Division, Fresenius Medical Care North America, Waltham, MA (K.E.C., F.W.M.); Massachusetts Institute of Technology, Harvard-MIT Biomedical Engineering Center, Institute for Medical Engineering and Science, Cambridge, MA (E.R.E.); and Cardiovascular Medicine Division, Brigham and Women's Hospital, Boston, MA (E.R.E.).
authors.forename: Franklin W
authors.initials: FW
authors.lastname: Maddux
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000150:complications / Q000188:drug therapy* / Q000378:metabolism; D001562:Benzimidazoles / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D000069604:Dabigatran; D016208:Databases, Factual; D004305:Dose-Response Relationship, Drug; D004363:Drug Utilization; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced / Q000453:epidemiology; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D007668:Kidney / Q000187:drug effects / Q000378:metabolism; D007676:Kidney Failure, Chronic / Q000150:complications* / Q000378:metabolism; D008297:Male; D016555:Matched-Pair Analysis; D008875:Middle Aged; D009025:Morpholines / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D016012:Poisson Distribution; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data* / Q000639:trends; D006435:Renal Dialysis; D012189:Retrospective Studies; D012306:Risk; D000069552:Rivaroxaban; D020521:Stroke / Q000209:etiology; D013876:Thiophenes / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D014859:Warfarin / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use; D015091:beta-Alanine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000493:pharmacokinetics / Q000627:therapeutic use
chemical_list: D000925:Anticoagulants; D001562:Benzimidazoles; D009025:Morpholines; D013876:Thiophenes; D015091:beta-Alanine; D014859:Warfarin; D000069552:Rivaroxaban; D000069604:Dabigatran
keywords: atrial fibrillation; dabigatran; dialysis; rivaroxaban; warfarin