The prescribing information provides information on medicines. This study will check the number of patients starting febuxostat and the number of febuxostat users with cardiovascular disease after changes to the prescribing information.
This is a descriptive, cross-sectional, non-interventional study of participants with gout. The study will evaluate the impact of the 2019 labeling changes (boxed warning and modified indication), based upon results of the cardiovascular safety of febuxostat and allopurinol in participants with gout and cardiovascular morbidities (CARES) trial, on febuxostat utilization. The study will evaluate data from approximately 24046 participants. The data will be collected from optum clinformatics dataMart (CDM) including the medicare advantage administrative US claims database and the IQVIA pharmetrics plus claims database. All participants will be enrolled in a single observational cohort. This trial will be conducted in the United States. The overall duration of this study is approximately 14 months.
Study Type
OBSERVATIONAL
Enrollment
24,046
Central Contact
Cambridge, Massachusetts, United States
Number of Participants Newly Initiating Febuxostat Therapy Versus Prevalent New Users
Participants will be categorized into new users and prevalent new users. New users are participants who were naïve to allopurinol, defined as no record of allopurinol use in all historic pharmacy or medical claims at any time prior to initiation of febuxostat. Prevalent new users are participants who had used allopurinol and switched, defined as at least one record of allopurinol use in all historic pharmacy or medical claims at any time prior to initiation of febuxostat.
Time frame: Up to 14 months
Number of Participants With Established Cardiovascular Disease (CVD)
Participants initiating febuxostat will be categorized as having (Yes/No) to each of the following morbidities at any time prior to initiation of febuxostat: myocardial infarction (MI), unstable angina, stroke (hemorrhagic and ischemic), transient ischemic attack, peripheral vascular disease, diabetes mellitus with evidence of macrovascular or microvascular disease.
Time frame: Up to 14 months
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