Drug Utilization Study to Describe the Pattern of Febuxostat Use in Relationship to Allopurinol Following Addition of the Boxed Warning and Modification of the Indication Based on the Results of the CARES Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24,046
- 试验地点
- 1
- 主要终点
- Number of Participants Newly Initiating Febuxostat Therapy Versus Prevalent New Users
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Index fill date on or after 01 June
- •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.
排除标准
- 未提供
结局指标
主要结局
Number of Participants Newly Initiating Febuxostat Therapy Versus Prevalent New Users
时间窗: Up to 14 months
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.
Number of Participants With Established Cardiovascular Disease (CVD)
时间窗: Up to 14 months
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.
次要结局
未报告次要终点