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Eliquis (Apixaban) & Gastrointestinal (GI) Bleed, Intracranial Hemorrhage, and Stroke

Basic Details
Status
Complete
Last Updated
Monday, March 18, 2024
Original Posting Date
Health Outcome(s)
gastrointestinal (GI) bleed
intracranial hemorrhage
stroke
Purpose
Drug and Outcome Analysis
Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
No
Regulatory Determination / Use

This study was previously conducted in the Mini-Sentinel pilot program to assess the benefit-risk profile of using Eliquis (apixaban) compared to warfarin in patients with atrial fibrillation (AF). The original analysis suggested a signal of harm for apixaban use related to the health outcome of intracranial hemorrhage (ICH). However, the number of apixaban users in the original analysis was low as apixaban was approved in 2014. Therefore, an updated study with increased sample size was required. This study found that in AF patients of all ages initiating either apixaban or warfarin for stroke prevention, apixaban was associated with a decreased risk of gastrointestinal (GI) bleeding, ICH, and ischemic stroke compared with warfarin. No regulatory action was required as findings suggested a favorable benefit-risk profile for apixaban compared to warfarin for stroke prevention in patients with AF. 

Analytic Code Link(s) (1)
Stroke, Gastrointestinal Bleeding, and Intracranial Hemorrhage Following Apixaban or Warfarin Use in Patients with Non-Valvular Atrial Fibrillation: A Propensity Score Matched Analysis
Result(s) (2)
Stroke, Gastrointestinal Bleeding, and Intracranial Hemorrhage Following Apixaban or Warfarin Use in Patients with Non-Valvular Atrial Fibrillation: A Propensity Score Matched Analysis Ischemic Stroke, Intracranial Hemorrhage, and Gastrointestinal Hemorrhage Among New Users of Apixaban and Warfarin
Related Publication(s) and/or Presentation(s) (2)
Publication: Risk of Stroke and Bleeding in Atrial Fibrillation Treated with Apixaban Compared with Warfarin Presentation: Risk of Stroke and Bleeding in Nonvalvular Atrial Fibrillation Treated with Apixaban Compared to Warfarin in the Sentinel System