Cutaneous Small-Vessel Vasculitis following Non-Vitamin K Antagonist Oral Anticoagulants (NOACs), Warfarin, or Allopurinol Use in Patients with Atrial Fibrillation: A Descriptive Analysis

Project Title Cutaneous Small-Vessel Vasculitis following Non-Vitamin K Antagonist Oral Anticoagulants (NOACs), Warfarin, or Allopurinol Use in Patients with Atrial Fibrillation: A Descriptive Analysis
Date Posted
Monday, September 14, 2020
Project ID
cder_mpl1r_wp171
Status
Complete
Deliverables
Related Links
Description

The purpose of this request was to calculate the number of treated patients and time to treatment among patients exposed to either non‐vitamin K antagonist oral anticoagulants (NOACs), warfarin, or allopurinol who had a prior diagnosis of atrial fibrillation in the Sentinel Distributed Database (SDD). The outcomes of interest were cutaneous small‐vessel vasculitis (CSVV) followed by a treatment of prednisone or prednisolone or steroid medication within 90 days.

The study period included data from October 19, 2010 to December 31, 2018. We distributed this request to 17 Data Partners on February 10, 2020.

Medical Product
allopurinol
non-vitamin K antagonist oral anticoagulants
warfarin
Health Outcome
cutaneous small vessel vasculitis
Population / Cohort
Individuals 21 years of age and older
Time Period
October 19, 2010 - December 31, 2018
Assessment Type
Exploratory Analyses
Study Type
Modular Program
Data Sources
Sentinel Distributed Database (SDD)
FDA Center
CDER
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