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Comparative Bleeding Risks Among NOAC Users for Nonvalvular Atrial Fibrillation Aged Under 65 years in the Sentinel System

Basic Details
Date
Type
Presentation
Description

Nonvitamin K antagonist oral anticoagulants (NOACs) are alternatives to warfarin for treatment of nonvalvular atrial fibrillation (NVAF). Randomized trials compared NOACs with warfarin, but not the safety of individual NOACs against each other. An FDA study using Medicare data concluded that among patients aged ≥65 years rivaroxaban had a less favorable safety profile compared to other NOACs; however, it is unclear if this safety profile persists in younger users

This presentation compares major extracranial bleeding (MEB), gastrointestinal (GI) bleeding, and intracranial hemorrhage (ICH) in NOAC users for NVAF aged <65 years in the FDA Sentinel System. It was presented at the 2024 ISPE Annual Meeting.

 
 
Materials

Comparative Bleeding Risks Among NOAC Users for Nonvalvular Atrial Fibrillation Aged <65 years in the Sentinel System

Information
Host

International Society for Pharmacoepidemiology (ISPE)

Related Assessment(s)
Sentinel Drug Analysis: Stroke, Intracranial Hemorrhage, and Bleeding following Dabigatran, Rivaroxaban, and Apixaban Use in Patients Aged 65 or Older: A Propensity Score Matched Analysis
Sentinel Drug Analysis: Occurrence of Stroke, Intracranial Hemorrhage, and Bleeding Outcomes Following Direct Oral Anticoagulant Use in Patients with Atrial Fibrillation: A Descriptive Analysis
Sentinel Drug Study: Eliquis (Apixaban), Pradaxa (Dabigatran), and Xarelto (Rivaroxaban) & Gastrointestinal Bleeding, Intracranial Hemorrhage, Major Extracranial Bleeding, and Thromboembolic Stroke
2024 ISPE Annual Meeting
Author(s)

Marie C. Bradley, Andrew L Simon, Joy Kolonoski, David J. Graham, Rongmei Zhang, John G. Connolly