title: Changes in Renal Function in Patients With Atrial Fibrillation: An Analysis From the RE-LY Trial.
abstract: BACKGROUND
  Vitamin K-dependent factors protect against vascular and renovascular calcification, and vitamin K antagonists may be associated with a decreased glomerular filtration rate (GFR).
  
  
  OBJECTIVE
  This study analyzed changes in GFR during long-term treatment with warfarin or dabigatran etexilate (DE) in patients enrolled in the RE-LY (Randomized Evaluation of Long Term Anticoagulation Therapy) trial.
  
  
  METHODS
  Of the 18,113 patients in the RE-LY study randomized to receive DE (110 mg or 150 mg twice daily) or warfarin, 16,490 patients with atrial fibrillation had creatinine values measured at baseline and at least 1 follow-up visit. Changes in GFR for up to 30 months were evaluated.
  
  
  RESULTS
  GFR declined in all treatment groups. After an average of 30 months, the mean ± SE decline in GFR was significantly greater with warfarin (-3.68 ± 0.24 ml/min) compared with DE 110 mg (-2.57 ± 0.24 ml/min; p = 0.0009 vs. warfarin) and DE 150 mg (-2.46 ± 0.23 ml/min; p = 0.0002 vs. warfarin). A decrease in GFR >25% was less likely with DE 110 mg (hazard ratio: 0.81 [95% confidence interval: 0.69 to 0.96]; p = 0.017) or DE 150 mg (hazard ratio: 0.79 [95% confidence interval: 0.68 to 0.93]; p = 0.0056) than with warfarin in the observation period >18 months. Patients with poor international normalized ratio control (i.e., time in therapeutic range <65%) exhibited a faster decline in GFR. A more pronounced decline in GFR was associated with previous warfarin use and with the presence of diabetes.
  
  
  CONCLUSIONS
  Patients with atrial fibrillation receiving oral anticoagulation exhibited a decline in renal function that was greater in those taking warfarin versus DE, and it was amplified by diabetes and previous vitamin K antagonist use. (Randomized Evaluation of Long Term Anticoagulant Therapy [RE-LY] With Dabigatran Etexilate; NCT00262600).
authors.affiliation: Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Homburg, Germany. Electronic address: michael.boehm@uks.eu.
authors.forename: Michael
authors.initials: M
authors.lastname: Böhm
authors.affiliation: Sidney Kimmel Medical College at Jefferson University, Philadelphia, Pennsylvania; Lankenau Institute for Medical Research and The Heart Center, Wynnewood, Pennsylvania.
authors.forename: Michael D
authors.initials: MD
authors.lastname: Ezekowitz
authors.affiliation: Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada.
authors.forename: Stuart J
authors.initials: SJ
authors.lastname: Connolly
authors.affiliation: Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada.
authors.forename: John W
authors.initials: JW
authors.lastname: Eikelboom
authors.affiliation: Department of Cardiology, J.W. Goethe University, Frankfurt/Main, Germany.
authors.forename: Stefan H
authors.initials: SH
authors.lastname: Hohnloser
authors.affiliation: Boehringer Ingelheim Pharmaceuticals, Ridgefield, Connecticut.
authors.forename: Paul A
authors.initials: PA
authors.lastname: Reilly
authors.affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
authors.forename: Helmut
authors.initials: H
authors.lastname: Schumacher
authors.affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany; Faculty of Medicine Mannheim at the University of Heidelberg, Heidelberg, Germany.
authors.forename: Martina
authors.initials: M
authors.lastname: Brueckmann
authors.affiliation: Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Homburg, Germany.
authors.forename: Stephan H
authors.initials: SH
authors.lastname: Schirmer
authors.affiliation: Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Homburg, Germany.
authors.forename: Mario T
authors.initials: MT
authors.lastname: Kratz
authors.affiliation: Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada.
authors.forename: Salim
authors.initials: S
authors.lastname: Yusuf
authors.affiliation: Department of Neurology, Universitätsklinikum Duisburg-Essen, Essen, Germany.
authors.forename: Hans-Christoph
authors.initials: HC
authors.lastname: Diener
authors.affiliation: Uppsala Clinical Research Center and Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden.
authors.forename: Ziad
authors.initials: Z
authors.lastname: Hijazi
authors.affiliation: Uppsala Clinical Research Center and Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden.
authors.forename: Lars
authors.initials: L
authors.lastname: Wallentin
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000494:pharmacology / Q000627:therapeutic use; D001281:Atrial Fibrillation / Q000175:diagnosis* / Q000188:drug therapy / Q000503:physiopathology*; D001562:Benzimidazoles / Q000494:pharmacology / Q000627:therapeutic use; D000069604:Dabigatran; D005260:Female; D005500:Follow-Up Studies; D005919:Glomerular Filtration Rate / Q000187:drug effects / Q000502:physiology*; D006801:Humans; D007668:Kidney / Q000187:drug effects / Q000502:physiology*; D008297:Male; D008875:Middle Aged; D011725:Pyridines / Q000494:pharmacology / Q000627:therapeutic use; D012307:Risk Factors; D016037:Single-Blind Method; D014859:Warfarin / Q000494:pharmacology / Q000627:therapeutic use
chemical_list: D000925:Anticoagulants; D001562:Benzimidazoles; D011725:Pyridines; D014859:Warfarin; D000069604:Dabigatran
keywords: anticoagulation; atrial fibrillation; renal function; thrombin inhibition; vitamin K antagonist