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Cutaneous Small-Vessel Vasculitis following Direct Oral Anticoagulants (DOACs), Warfarin, or Allopurinol Use in Patients with Atrial Fibrillation: A Descriptive Analysis

Basic Details
Date Posted
Status
Complete
Medical Product
allopurinol
direct oral anticoagulant (DOAC)
warfarin
Health Outcome(s)
cutaneous small-vessel vasculitis
Description

The purpose of this request was to calculate the number of treated patients and time to treatment among patients exposed to either direct oral anticoagulants (DOACs), 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.

Deliverables (1)
Sentinel Modular Program Report: Cutaneous Small-Vessel Vasculitis following Direct Oral Anticoagulants (DOACs), Warfarin, or Allopurinol Use in Patients with Atrial Fibrillation: A Descriptive Analysis
Additional Details
FDA Center
CDER
Time Period
October 19, 2010 - December 31, 2018
Analysis Type
Descriptive
Population / Cohort
Individuals 21 years of age and older
Data Sources
Sentinel Distributed Database (SDD)
Related Links
Sentinel Drug Analysis: Eliquis (Apixaban), Pradaxa (Dabigatran), and Xarelto (Rivaroxaban) & Cutaneous Small-Vessel Vasculitis
ICPE 2020: Incidence of Cutaneous Small Vessel Vasculitis associated with Oral Anticoagulant Use
Publication: Complementary Use of U.S. FDA’s Adverse Event Reporting System and Sentinel System to Characterize Direct Oral Anticoagulants‐Associated Cutaneous Small Vessel Vasculitis
Sentinel Drug Analysis: Cutaneous Small-Vessel Vasculitis following Dabigatran, Rivaroxaban, and Apixaban Use in Patients with Atrial Fibrillation: A Propensity Score Matched Analysis
Sentinel Drug Analysis: Direct Oral Anticoagulants (DOACs), Warfarin, Allopurinol, or Propylthiouracil Use in Patients with Cutaneous Small-Vessel Vasculitis: A Descriptive Analysis