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).

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).

• Authors: Michael Böhm, Michael D Ezekowitz, Stuart J Connolly, John W Eikelboom, Stefan H Hohnloser, Paul A Reilly, Helmut Schumacher, Martina Brueckmann, Stephan H Schirmer, Mario T Kratz, Salim Yusuf, Hans-Christoph Diener, Ziad Hijazi, Lars Wallentin
• Journal: Journal of the American College of Cardiology (J Am Coll Cardiol) Vol. 65 Issue 23 Pg. 2481-93 (Jun 16 2015) ISSN: 1558-3597 [Electronic] United States
• PMID: 26065986 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Chemical References

• Anticoagulants
• Benzimidazoles
• Pyridines
• Warfarin
• Dabigatran

Topics

• Aged
• Aged, 80 and over
• Anticoagulants (pharmacology, therapeutic use)
• Atrial Fibrillation (diagnosis, drug therapy, physiopathology)
• Benzimidazoles (pharmacology, therapeutic use)
• Dabigatran
• Female
• Follow-Up Studies
• Glomerular Filtration Rate (drug effects, physiology)
• Humans
• Kidney (drug effects, physiology)
• Male
• Middle Aged
• Pyridines (pharmacology, therapeutic use)
• Risk Factors
• Single-Blind Method
• Warfarin (pharmacology, therapeutic use)