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Characteristics of Gout Patients and Use of Urate-Lowering Therapies

Basic Details
Date Posted
Status
Complete
Medical Product
urate-lowering therapies
Description

The goal of this request was to assess characteristics of gout patients and use of urate lowering therapies (ULT) among individuals in the Sentinel Distributed Database (SDD). This request contains three reports: 

  • Report 1 examines counts of individuals with gout diagnoses, and cardiovascular morbidities and gout severity among those individuals.
  • Report 2 contains counts of individuals using the ULTs febuxostat and allopurinol, and captures switching between ULT drug products and doses.
  • Report 3 contains cumulative exposure duration of febuxostat and allopurinol prior to dose or drug switching.

Data from January 1, 2009 to December 31, 2016 from 17 Data Partners contributing to the SDD were included in these reports. This request was distributed to Data Partners on October 25, 2018.

Deliverables (3)
Sentinel Modular Program Report: Characteristics of Gout Patients and Use of Urate-Lowering Therapies, Report 1 Sentinel Modular Program Report: Characteristics of Gout Patients and Use of Urate-Lowering Therapies, Report 2 Sentinel Modular Program Report: Characteristics of Gout Patients and Use of Urate-Lowering Therapies, Report 3
Additional Details
FDA Center
CDER
Time Period
January 1, 2009 - December 31, 2016
Analysis Type
Descriptive
Data Sources
Sentinel Distributed Database (SDD)
Related Links
Sentinel Drug Study: Uloric (febuxostat) & Duration of Use and User Characteristics
Joint Meeting of the Arthritis Advisory Committee (AAC) and Drug Safety and Risk Management (DSaRM) Advisory Committee: Urate-Lowering Therapies and Gout
2019 ICPE Presentation: Characteristics of Febuxostat and Allopurinol Initiators and Utilization Patterns in Real-World Settings
Counts of Individuals with Gout Using Urate-Lowering Therapy (ULT) and Switching between ULT Products: A Descriptive Analysis