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Thromboembolic Stroke, Major Extracranial Bleeding, Gastrointestinal Bleeding, and Intracranial Hemorrhage following Direct Oral Anticoagulant Use in Patients Aged 65 or Older: An Inverse Probability of Treatment Weighting (IPTW) Analysis

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

This analysis investigates the comparative risk of thromboembolic stroke, intracranial hemorrhage, gastrointestinal bleeding, and major extracranial bleeding outcomes among dabigatran, rivaroxaban, and apixaban users aged over 65 years with non-valvular atrial fibrillation in the Sentinel Distributed Database (SDD). This analysis used inverse probability of treatment weighting (IPTW) to adjust for potential confounding, in contrast to a previous request which used propensity score matching.

The study period included data from October 19, 2010 through September 30, 2015.

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 Analytic Package: Thromboembolic Stroke, Major Extracranial Bleeding, Gastrointestinal Bleeding, and Intracranial Hemorrhage following Direct Oral Anticoagulant Use in Patients Aged 65 or Older: An IPTW Analysis Sentinel Modular Program Report: Thromboembolic Stroke, Major Extracranial Bleeding, Gastrointestinal Bleeding, and Intracranial Hemorrhage following Direct Oral Anticoagulant Use in Patients Aged 65 or Older: An IPTW 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
Sentinel Drug Study: Eliquis (Apixaban), Pradaxa (Dabigatran), and Xarelto (Rivaroxaban) & Gastrointestinal Bleeding, Intracranial Hemorrhage, Major Extracranial Bleeding, and Thromboembolic Stroke
Intracranial Hemorrhage Algorithm Defined in "Thromboembolic Stroke, Major Extracranial Bleeding, Gastrointestinal Bleeding, and Intracranial Hemorrhage following Direct Oral Anticoagulant Use in Patients Aged 65 and Older: An IPTW Analysis"
Major Extracranial Bleeding Algorithm Defined in "Thromboembolic Stroke, Major Extracranial Bleeding, Gastrointestinal Bleeding, and Intracranial Hemorrhage following Direct Oral Anticoagulant Use in Patients Aged 65 and Older: An IPTW Analysis"
Thromboembolic Stroke Algorithm Defined in "Thromboembolic Stroke, Major Extracranial Bleeding, Gastrointestinal Bleeding, and Intracranial Hemorrhage following Direct Oral Anticoagulant Use in Patients Aged 65 and Older: An IPTW Analysis"
Gastrointestinal Bleeding Algorithm Defined in "Thromboembolic Stroke, Major Extracranial Bleeding, Gastrointestinal Bleeding, and Intracranial Hemorrhage following Direct Oral Anticoagulant Use in Patients Aged 65 and Older: An IPTW Analysis"