Drug utilisation study of Intuniv® (guanfacine extended release) in European Countries – A prescriber survey (Intuniv survey study Europe)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

  Other
• Non-interventional study design, other:
  Multinational, non-interventional and anonymous survey

Study drug and medical condition

• Name of medicine:
  INTUNIV
• Study drug International non-proprietary name (INN) or common name:
  GUANFACINE HYDROCHLORIDE
• 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:
  A survey of physicians prescribing Intuniv® for the treatment of attention deficit/hyperactivity disorder (ADHD) in Belgium, Finland, Ireland, and Netherlands from 2019 to 2022.; Inclusion criteria:; • Prescribers of Intuniv®, i.e. physicians who know and have prescribed the drug at least once during the previous 12 months (or, for the first report, since country specific launch) (paediatricians, psychiatrists, neurologists and GPs).; ; Exclusion criteria: ; Inactive and retired physicians (when documented information is available to identify them) will be deleted from the contact lists before randomisation.; The following exclusion criteria will be checked at the beginning of the web questionnaire:; • Physicians who do not treat patients or who may have a conflict of interest (i.e. physicians employed by regulatory bodies or pharmaceutical industries).
• Age groups:
  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  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 attention deficit/hyperactivity disorder
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  Overall: Drug utilization study with Intuniv® in European countries until 2021. Results will be reported annually. Study objectives: 1.characterize patients, focussing on indications other than ADHD, children <6 years, adults 2. describe prescribing patterns of Intuniv® among physicians 3. assess compliance with indication, visits and measurements needed during the first year of treatment</6></6>
• Data analysis plan:
  Data analysis will be done descriptively as specified in the statistical analysis plan.

Documents

Study results

Intuniv EU survey study redacted abstract final report