Febuxostat-5006: 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 (Febuxostat Drug Utilization Study)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cross-sectional

  Other
• Non-interventional study design, other:
  Descriptive study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  FEBUXOSTAT
• Medical condition to be studied:
  Gout

  Myocardial infarction

  Angina unstable

  Haemorrhagic stroke

  Ischaemic stroke

  Transient ischaemic attack

  Peripheral vascular disorder

Population studied

• Short description of the study population:
  The study population included gout patients aged 21 years or older initiated febuxostat therapy on or after 01 June 2016 identified from the Optum Clinformatics DataMart (CDM) and the IQVIA PharMetrics Plus claims database. ; 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 [ICD]-9-CM: 274.x or ICD-10: M10.x) at any time in the patient’s record.; • Age ≥21 years at index fill date.; • Continuously enrolled for at least 12 months prior to index fill date.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with gout
• Estimated number of subjects:
  24046

Study design details

• Main study objective:
  Primary objective of the study is to describe the number and proportion of patients initiating febuxostat as new users (that is, without previous allopurinol therapy) versus prevalent new users (ie, with previous allopurinol therapy) of ULT and to describe the number and proportion of febuxostat users with established CVD.
• Outcomes:
  The primary outcomes will assess the number of participants newly initiating febuxostat therapy versus prevalent new users and number of participants with established cardiovascular disease (CVD).
• Data analysis plan:
  Standard descriptive statistics method will be used to report mean, standard deviation, median, range, temporal trends to describe the dispensing pattern of febuxostat.

Documents

Study results

Febuxostat-5006 RDS 2021-06-30