Dabigatran and Warfarin Use Among Members with Atrial Fibrillation and Other Pre-Existing Conditions

Project Title Dabigatran and Warfarin Use Among Members with Atrial Fibrillation and Other Pre-Existing Conditions
Date Posted
Thursday, July 21, 2016
Status
Complete
Deliverables
Related Links
Description

Modular program-based one-time assessment of new use of the anticoagulants dabigatran and warfarin among individuals with a pre-existing condition of atrial fibrillation and other various pre-existing conditions, including anemia, chronic obstructive pulmonary disease (COPD), diabetes, hypertension, chronic kidney failure, acute kidney failure, peptic ulcer disease, acute myocardial infarction (AMI), heart failure, peripheral vascular disease, hospitalized stroke, urinary catheter, hospitalized bleed, chronic liver disease, hypercholesterolemia, malignancy, coronary revascularization, cerebral revascularization, transient ischemic attack (TIA), cerebrovascular disease, urinary incontinence, hospitalized pneumonia, cardioversion, cardioablation, intravenous (IV) anticoagulants, non-steroidal anti-inflammatory drugs (NSAIDs), proton pump inhibitors (PPIs), selective serotonin reuptake inhibitors (SSRIs), thyroid replacement medications, insulin, metformin, sulfonylureas, other diabetes medications, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor blockers (ARBs), anti-arrhythmic, anti-platelet medications, beta-blockers, calcium channel blockers, digoxin, loop diuretics, potassium-sparing diuretics, thiazides, amiodarone, dronedarone, estrogen replacement, H2 antagonists, nitrates, statins, fibrates, antifungal medications, verapamil. Members were required to have evidence of these pre-existing conditions in the six months prior to the new dabigatran/warfarin use. The query was run against the Mini-Sentinel Distributed Database (MSDD) for the time period of October 19, 2010 to December 31, 2014.  Modular programs are adaptable standardized programs. Results were generated using the Cohort Identification and Descriptive Analysis (CIDA) tool; click here for more information.  Queries were distributed in July 2015. This report includes data from 15 Data Partners.
 
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Medical Product
dabigatran
warfarin
Population / Cohort
All individuals with a pre-existing condition of atrial fibrillation
Time Period
October 19, 2010 - December 31, 2014
Assessment Type
Exploratory Analyses
Study Type
Modular Program
Data Sources
Mini-Sentinel Distributed Database (MSDD)
FDA Center
CDER
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