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

Basic Details
Date Posted
Thursday, October 29, 2020
Status
In progress
Medical Product
apixaban
dabigatran
non-vitamin K antagonist oral anticoagulants
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 under 65 years with non-valvular atrial fibrillation in the Sentinel Distributed Database (SDD).

The study period included data from October 19, 2010 to February 29, 2020.

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.

Additional Details
FDA Center
CDER
Time Period
October 19, 2010 - February 29, 2020
Study Type
Modular Program
Assessment Type
Safety Analyses
Population / Cohort
Individuals 21 to 64 years of age
Data Sources
Sentinel Distributed Database (SDD)