Patient Characteristics and Clinical Outcomes with Low-Dose Dabigatran

Background/aimsDabigatran, an oral direct thrombin inhibitor, is used in patients with non-valvular atrial fibrillation to reduce thromboembolic events. Whereas the 150 mg dosing regimen has been extensively studied in clinical setting, to date, there is no clinical data on the 75 mg (low dose, “LD”...

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Main Authors: Ramin Ebrahimi, Janet K. Han, Seung H. Goe, Michelle Treadwell, Zenaida Feliciano
Format: Article
Language:English
Published: Frontiers Media S.A. 2017-07-01
Series:Frontiers in Cardiovascular Medicine
Subjects:
Online Access:http://journal.frontiersin.org/article/10.3389/fcvm.2017.00042/full
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author Ramin Ebrahimi
Ramin Ebrahimi
Janet K. Han
Janet K. Han
Seung H. Goe
Michelle Treadwell
Zenaida Feliciano
Zenaida Feliciano
author_facet Ramin Ebrahimi
Ramin Ebrahimi
Janet K. Han
Janet K. Han
Seung H. Goe
Michelle Treadwell
Zenaida Feliciano
Zenaida Feliciano
author_sort Ramin Ebrahimi
collection DOAJ
description Background/aimsDabigatran, an oral direct thrombin inhibitor, is used in patients with non-valvular atrial fibrillation to reduce thromboembolic events. Whereas the 150 mg dosing regimen has been extensively studied in clinical setting, to date, there is no clinical data on the 75 mg (low dose, “LD”) regimen. In this study, we evaluated patient characteristics and clinical outcomes in 49 patients treated with LD dabigatran.MethodsElectronic medical records were utilized to compare patients from one medical center treated with LD dabigatran to those from the warfarin arm of the RE-LY trial.ResultsCompared to those from the warfarin arm of the RE-LY trial, the LD dabigatran patients were significantly older (82.6 vs. 71.6 years, p < 0.001), had higher prevalence of diabetes (42.9 vs. 23%, p < 0.001), were predominantly male (100 vs. 63.3%, p < 0.001), and had higher CHADS2 score (2.8 vs. 2.1, p < 0.001). Only 9 (18%) patients had creatinine clearance of <30 ml/min and none were on concomitant medications that required dose adjustment to LD dabigatran. During a mean follow up of 10.1 months, there were no thromboembolic events, no cerebrovascular events, and seven bleeding events in the LD dabigatran group of which only two required blood transfusion.ConclusionIn this database, most patients received LD dabigatran based on characteristics not related to the approved indications for this dose. The exploratory clinical outcomes of using LD dabigatran outside of the current approved indications are promising in this high-risk population and deserve further investigation to better understand the role of LD dabigatran in clinical practice.
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spelling doaj.art-9810bff9813e4f42aaea5c2c496687082022-12-22T00:30:32ZengFrontiers Media S.A.Frontiers in Cardiovascular Medicine2297-055X2017-07-01410.3389/fcvm.2017.00042251210Patient Characteristics and Clinical Outcomes with Low-Dose DabigatranRamin Ebrahimi0Ramin Ebrahimi1Janet K. Han2Janet K. Han3Seung H. Goe4Michelle Treadwell5Zenaida Feliciano6Zenaida Feliciano7Department of Cardiology, Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles, CA, United StatesDepartment of Medicine, University of California, Los Angeles, Los Angeles, CA, United StatesDepartment of Cardiology, Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles, CA, United StatesDepartment of Medicine, University of California, Los Angeles, Los Angeles, CA, United StatesDepartment of Pharmacy, Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles, CA, United StatesDepartment of Cardiology, Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles, CA, United StatesDepartment of Cardiology, Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles, CA, United StatesDepartment of Medicine, University of California, Los Angeles, Los Angeles, CA, United StatesBackground/aimsDabigatran, an oral direct thrombin inhibitor, is used in patients with non-valvular atrial fibrillation to reduce thromboembolic events. Whereas the 150 mg dosing regimen has been extensively studied in clinical setting, to date, there is no clinical data on the 75 mg (low dose, “LD”) regimen. In this study, we evaluated patient characteristics and clinical outcomes in 49 patients treated with LD dabigatran.MethodsElectronic medical records were utilized to compare patients from one medical center treated with LD dabigatran to those from the warfarin arm of the RE-LY trial.ResultsCompared to those from the warfarin arm of the RE-LY trial, the LD dabigatran patients were significantly older (82.6 vs. 71.6 years, p < 0.001), had higher prevalence of diabetes (42.9 vs. 23%, p < 0.001), were predominantly male (100 vs. 63.3%, p < 0.001), and had higher CHADS2 score (2.8 vs. 2.1, p < 0.001). Only 9 (18%) patients had creatinine clearance of <30 ml/min and none were on concomitant medications that required dose adjustment to LD dabigatran. During a mean follow up of 10.1 months, there were no thromboembolic events, no cerebrovascular events, and seven bleeding events in the LD dabigatran group of which only two required blood transfusion.ConclusionIn this database, most patients received LD dabigatran based on characteristics not related to the approved indications for this dose. The exploratory clinical outcomes of using LD dabigatran outside of the current approved indications are promising in this high-risk population and deserve further investigation to better understand the role of LD dabigatran in clinical practice.http://journal.frontiersin.org/article/10.3389/fcvm.2017.00042/fulllow-dose dabigatranatrial fibrillationdabigatran 75 mgoral anticoagulantpatient demographics
spellingShingle Ramin Ebrahimi
Ramin Ebrahimi
Janet K. Han
Janet K. Han
Seung H. Goe
Michelle Treadwell
Zenaida Feliciano
Zenaida Feliciano
Patient Characteristics and Clinical Outcomes with Low-Dose Dabigatran
Frontiers in Cardiovascular Medicine
low-dose dabigatran
atrial fibrillation
dabigatran 75 mg
oral anticoagulant
patient demographics
title Patient Characteristics and Clinical Outcomes with Low-Dose Dabigatran
title_full Patient Characteristics and Clinical Outcomes with Low-Dose Dabigatran
title_fullStr Patient Characteristics and Clinical Outcomes with Low-Dose Dabigatran
title_full_unstemmed Patient Characteristics and Clinical Outcomes with Low-Dose Dabigatran
title_short Patient Characteristics and Clinical Outcomes with Low-Dose Dabigatran
title_sort patient characteristics and clinical outcomes with low dose dabigatran
topic low-dose dabigatran
atrial fibrillation
dabigatran 75 mg
oral anticoagulant
patient demographics
url http://journal.frontiersin.org/article/10.3389/fcvm.2017.00042/full
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