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Stroke, Intracranial Hemorrhage, and Bleeding following Dabigatran, Rivaroxaban, and Apixaban Use in Patients Aged 65 or Older: A Propensity Score Matched Analysis

Basic Details
Date Posted
Status
Complete
Medical Product
apixaban
dabigatran
rivaroxaban
Health Outcome(s)
bleeding event
intracranial hemorrhage
stroke
Description

In this report we compared risk of stroke, intracranial hemorrhage, and bleeding outcomes associated with use of dabigatran, rivaroxaban, and apixaban in those aged 65 years or older in the Sentinel Distributed Database (SDD).

The study period included data from October 19, 2010 to September 30, 2015. We distributed this request to 1 Data Partner on December 20, 2019.

The analytic package associated with this analysis can be found externally in Sentinel's Git Repository located here. The Git Repository serves as Sentinel's version control tracking system for analytic packages and technical documentation.

Deliverables (2)
Sentinel Modular Program Report: Stroke, Intracranial Hemorrhage, and Bleeding following Dabigatran, Rivaroxaban, and Apixaban Use in Patients Aged 65 or Older: A Propensity Score Matched Analysis Sentinel Analytic Package: Stroke, Intracranial Hemorrhage, and Bleeding following Dabigatran, Rivaroxaban, and Apixaban Use in Patients Aged 65 or Older: A Propensity Score Matched Analysis
Additional Details
FDA Center
CDER
Time Period
October 19, 2010 - September 30, 2015
Analysis Type
Retrospective Inferential
Population / Cohort
Individuals 65 years of age and older
Data Sources
Sentinel Distributed Database (SDD)
Related Links
Gastrointestinal Bleeding Algorithm Defined in "Stroke, Intracranial Hemorrhage, and Bleeding following Dabigatran, Rivaroxaban, and Apixaban Use in Patients Aged 65 or Older: A Propensity Score Matched Analysis"
Thromboembolic Stroke Algorithm Defined in "Stroke, Intracranial Hemorrhage, and Bleeding following Dabigatran, Rivaroxaban, and Apixaban Use in Patients Aged 65 or Older: A Propensity Score Matched Analysis"
Intracranial Hemorrhage Algorithm Defined in "Stroke, Intracranial Hemorrhage, and Bleeding following Dabigatran, Rivaroxaban, and Apixaban Use in Patients Aged 65 or Older: A Propensity Score Matched Analysis"
Major Extracranial Bleeding Algorithm Defined in "Stroke, Intracranial Hemorrhage, and Bleeding following Dabigatran, Rivaroxaban, and Apixaban Use in Patients Aged 65 or Older: A Propensity Score Matched Analysis"
Thromboembolic Stroke, Intracranial Hemorrhage, Gastrointestinal Bleeding, and Major Extracranial Bleeding following Dabigatran, Rivaroxaban, and Apixaban Use in Patients with Atrial Fibrillation: A Propensity Score Matched Analysis
Sentinel Drug Study: Eliquis (Apixaban), Pradaxa (Dabigatran), and Xarelto (Rivaroxaban) & Gastrointestinal Bleeding, Intracranial Hemorrhage, Major Extracranial Bleeding, and Thromboembolic Stroke
Presentation: Replicating the Findings of a Medicare Study on Stroke, and Bleeding Risk in Patients Using NOACs for Atrial Fibrillation in the Sentinel System
Presentation: Comparative Bleeding Risks Among NOAC Users for Nonvalvular Atrial Fibrillation Aged <65 years in the Sentinel System