Characteristics of Gout Patients and Use of Urate-Lowering Therapies

Project Title Characteristics of Gout Patients and Use of Urate-Lowering Therapies
Date Posted
Friday, March 22, 2019
Project ID
cder_mpl1r_wp123, cder_mpl1r_wp126
Status
Complete
Deliverables
Related Links
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.

Medical Product
urate-lowering therapies
Health Outcome
gout
Time Period
January 1, 2009 to December 31, 2016
Assessment Type
Safety Analyses
Study Type
Modular Program
Data Sources
Sentinel Distributed Database (SDD)
FDA Center
CDER