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J Am Coll Cardiol. 2015 Jun 16;65(23):2481-93. doi: 10.1016/j.jacc.2015.03.577.

Changes in Renal Function in Patients With Atrial Fibrillation: An Analysis From the RE-LY Trial.

Author information

1
Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Homburg, Germany. Electronic address: michael.boehm@uks.eu.
2
Sidney Kimmel Medical College at Jefferson University, Philadelphia, Pennsylvania; Lankenau Institute for Medical Research and The Heart Center, Wynnewood, Pennsylvania.
3
Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada.
4
Department of Cardiology, J.W. Goethe University, Frankfurt/Main, Germany.
5
Boehringer Ingelheim Pharmaceuticals, Ridgefield, Connecticut.
6
Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
7
Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany; Faculty of Medicine Mannheim at the University of Heidelberg, Heidelberg, Germany.
8
Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Homburg, Germany.
9
Department of Neurology, Universitätsklinikum Duisburg-Essen, Essen, Germany.
10
Uppsala Clinical Research Center and Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden.

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).

OBJECTIVES:

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).

KEYWORDS:

anticoagulation; atrial fibrillation; renal function; thrombin inhibition; vitamin K antagonist

PMID:
26065986
DOI:
10.1016/j.jacc.2015.03.577
[Indexed for MEDLINE]
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