Original ResearchFull Report: Clinical—Alimentary TractGastrointestinal Safety of Direct Oral Anticoagulants: A Large Population-Based Study
Section snippets
Data Source
The data for this analysis came from OptumLabs Data Warehouse, which includes a geographically diverse adult population covered through both commercial insurance and Medicare Advantage in the United States.3 Inpatient, outpatient, and pharmacy claims data are available on >120 million enrollees. Medical claims include International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) diagnosis codes, ICD-9 procedure codes, Current Procedural Terminology, Version 4
Baseline Characteristics
There were 372,380 continuously enrolled patients who filled prescriptions for DOACs in the period of observation (October 1, 2010 to February 28, 2015) of which 182,896 had AF at baseline. After exclusion of patients with valvular heart disease, dialysis, kidney transplant, or end-stage renal disease (n = 180,328) we were left with a source population of 43,303 patients (6576 apixaban, 17,426 dabigatran, and 19,301 rivaroxaban), from which to create the propensity score matched sub-cohorts for
Discussion
This study directly compared the comparative risk of GI bleeding for each of the 3 DOACs (dabigatran, rivaroxaban, and apixaban) frequently used for the treatment of nonvalvular AF patients. Our use of a large administrative claims database of commercially insured US adult patients and enrollees in Medicare Advantage permitted the direct comparison between multiple DOACs using 1:1 propensity score matched sub-cohorts and Cox regression. We showed that there were significant differences in the
Acknowledgments
Author contributions: Study concept and design: Drs Abraham and Shah. Acquisition, analysis of data: Drs Shah, Abraham, Yao, and Ms Sangaralingham. Dr Yao had full access to the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Interpretation of data: Drs Abraham, Shah, Yao, Noseworthy, and Ms Sangaralingham.
Drafting of the manuscript: Drs Abraham, Shah, and Ms Sangaralingham. Critical revision of the manuscript for important
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Conflicts of interest The authors disclose no conflicts.
Funding This study was funded by the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery. The design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication were solely the responsibility of the authors listed. Dr Yao had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis