SHP503-803: Drug Utilization Study with Intuniv® in Australia

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Combined primary data collection and secondary use of data

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (C02AC02) guanfacine

  guanfacine
• Medical condition to be studied:
  Attention deficit hyperactivity disorder

Population studied

• Short description of the study population:
  Intuniv® for treatment of ADHD in children and adolescents in Australia in 2018; Patients who have been prescribed Intuniv at least once during the reporting period. For this third (final) study report, the observation period was from 01 February 2020 to 31 January 2021 for the annual and from 01 February 2018 (the launch date in Australia) to 31 January 2021 for the cumulative reporting period. ; Subjects and Study Size, Including Dropouts; The following numbers of patients and prescriptions are included in this third (final) report.; • NostraData database:; o Annual reporting period: 21,028 patients, 152,837 prescriptions; o Cumulative reporting period: 27,461 patients, 260,460 prescriptions; • Annual physician survey (2021): 26 physicians, 104 patients.
• Age groups:
  • Paediatric Population (< 18 years)

    • Adolescents (12 to < 18 years)
    • Children (2 to < 12 years)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with attention deficit hyperactivity disorder
• Estimated number of subjects:
  100

Study design details

• Main study objective:
  The overall objective is to provide data on an annual basis for 3 years in Australia to evaluate drug utilization and monitor off-label use of Intuniv®
• Outcomes:
  1.Number of Participants Based on Indication of Use of Intuniv 2.Number of Participants with Presence/Absence of Contraindications, 1.Number of Participants Based on Patterns of Drug Use 2.Number of Participants Stratified by Prescriber Information Based on Physician Survey 3.Frequency of Weight Monitoring of Participants by Physician 4.Frequency of Blood Pressure Monitoring of Participants by Physician 5.Frequency of Heart Rate Monitoring of Participants by Physician
• Data analysis plan:
  Descriptive analyses will be performed based on the prescriptions contained in the NostraData database from each 12-month reporting period. The use of Intuniv® will be analysed using the prescriptions collected during the 3-year assessment period.