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Early adoption of dabigatran and its dosing in US patients with atrial fibrillation: results from the outcomes registry for better informed treatment of atrial fibrillation.

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Date
2013-11-25
Authors
Steinberg, Benjamin A
Holmes, Dajuanicia N
Piccini, Jonathan P
Ansell, Jack
Chang, Paul
Fonarow, Gregg C
Gersh, Bernard
Mahaffey, Kenneth W
Kowey, Peter R
Ezekowitz, Michael D
Singer, Daniel E
Thomas, Laine
Peterson, Eric D
Hylek, Elaine M
Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) Investigators and Patients
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Abstract
BACKGROUND: Dabigatran is a novel oral anticoagulant approved for thromboprophylaxis in atrial fibrillation. Adoption patterns of this new agent in community practice are unknown. METHODS AND RESULTS: We studied patterns of dabigatran use among patients enrolled in the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) Registry between June 2010 and August 2011 and followed for 12 months. Among 9974 atrial fibrillation patients included, 1217 (12%) were treated with dabigatran during the study. Overall, patients receiving dabigatran were younger (median age 72 versus 75 years, P<0.0001), more likely to be white (92% versus 89%, P=0.005), more likely to have private insurance (33% versus 25%, P<0.0001), and less likely to have prior cardiovascular disease (4% versus 33%, P<0.0001). They had more new-onset atrial fibrillation (8.8% versus 4.1%, P<0.0001), lower CHADS2 scores (estimated risk based on the presence of congestive heart failure, hypertension, aged ≥75 years, diabetes mellitus, and prior stroke or transient ischemic attack; mean 2.0 versus 2.3, P<0.0001), and lower Anticoagulation and Risk Factors in Atrial Fibrillation scores (mean 2.4 versus 2.8, P<0.0001). More than half (n=14/25, 56%) of patients with severe kidney disease were not prescribed reduced dosing, whereas 10% (n=91/920) with preserved renal function received lower dosing. Among patients not on dabigatran at baseline, 8% had dabigatran initiated during follow-up. Patient education was significantly associated with switching from warfarin to dabigatran (adjusted odds ratio for postgraduate 1.73, P=0.007), whereas antiarrhythmic drug use significantly correlated with de novo adoption of dabigatran (adjusted odds ratio 2.4, P<0.0001). CONCLUSIONS: Patients receiving dabigatran were younger and at a lower risk of stroke and bleeding. Patients appeared to drive switching from warfarin, whereas clinical characteristics influenced de novo start of dabigatran. These data suggest cautious early uptake of dabigatran, and more careful attention to dosing adjustments is warranted. CLINICAL TRIAL REGISTRATION URL: Clinicaltrials.gov. Unique identifier: NCT01165710.
Type
Journal article
Subject
anticoagulant
atrial fibrillation
dabigatran
dosing
pharmacoepidemiology
Administration, Oral
Age Factors
Aged
Aged, 80 and over
Anticoagulants
Atrial Fibrillation
Benzimidazoles
Chi-Square Distribution
Comorbidity
Dabigatran
Drug Dosage Calculations
Drug Substitution
Female
Health Knowledge, Attitudes, Practice
Hemorrhage
Humans
Logistic Models
Male
Middle Aged
Odds Ratio
Patient Education as Topic
Practice Patterns, Physicians'
Proportional Hazards Models
Registries
Risk Factors
Socioeconomic Factors
Stroke
Time Factors
Treatment Outcome
United States
beta-Alanine
Permalink
https://hdl.handle.net/10161/15012
Published Version (Please cite this version)
10.1161/JAHA.113.000535
Publication Info
Steinberg, Benjamin A; Holmes, Dajuanicia N; Piccini, Jonathan P; Ansell, Jack; Chang, Paul; Fonarow, Gregg C; ... Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) Investigators and Patients (2013). Early adoption of dabigatran and its dosing in US patients with atrial fibrillation: results from the outcomes registry for better informed treatment of atrial fibrillation. J Am Heart Assoc, 2(6). pp. e000535. 10.1161/JAHA.113.000535. Retrieved from https://hdl.handle.net/10161/15012.
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Scholars@Duke

Peterson

Eric David Peterson

Fred Cobb, M.D. Distinguished Professor of Medicine
Dr Peterson is the Fred Cobb Distinguished Professor of Medicine in the Division of Cardiology, a DukeMed Scholar, and the Past Executive Director of the Duke Clinical Research Institute (DCRI), Durham, NC, USA. Dr Peterson is the Principal Investigator of the National Institute of Health, Lung and Blood Institute (NHLBI) Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure With Preserved Ejection Fraction (SPIRRIT) Trial  He is also the Principal I
This author no longer has a Scholars@Duke profile, so the information shown here reflects their Duke status at the time this item was deposited.
Piccini

Jonathan Paul Piccini Sr.

Professor of Medicine
Jonathan P. Piccini, MD, MHS, FACC, FAHA, FHRS is a clinical cardiac electrophysiologist and Associate Professor of Medicine with Tenure at Duke University Medical Center and the Duke Clinical Research Institute. He is the Director of the Cardiac Electrophysiology section at the Duke Heart Center. His focus is on the care of patients with atrial fibrillation and complex arrhythmias, with particular emphasis on catheter ablation, left atrial appendage occlusion, and lead extraction. His resear

Benjamin Steinberg

House Staff
Thomas

Laine Elliott Thomas

Professor of Biostatistics & Bioinformatics
As Deputy Director, Laine Thomas, PhD provides complementary leadership in strategy and development of the group and DCRI. She has an outstanding record of scientific and strategic collaboration, independent research, leadership and mentoring well known to her colleagues at the DCRI. Thomas joined the DCRI in 2009. She serves as Associate Director for Biostatistics at DCRI and Associate Chair for Equity, Diversity and Inclusion within the Department of
Alphabetical list of authors with Scholars@Duke profiles.
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