Drug Use Study of Febuxostat After Recent Changes in the Prescribing Information
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About
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.
Full description
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.
Enrollment
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Volunteers
Inclusion and exclusion criteria
Inclusion Criteria:
- Index fill date on or after 01 June 2016.
- Having at least one diagnosis for gout (identified with diagnosis codes, International Classification of Diseases, clinical modification, ninth revision [ICD-9-CM]: 274.x or International Classification of Diseases, tenth revision [ICD-10]: M10.x) at any time in the participant's record.
- Continuously enrolled for at least 12 months prior to index fill date.
Trial design
24,046 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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