DARWIN EU® – Trends in utilisation of Attention-Deficit Hyperactivity Disorder (ADHD) Medications

Study type

• Study topic:
  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:
  Cohort

Study drug and medical condition

• Name of medicine, other:
  Lisdexamfetamine (N06BA12) ; Methylphenidate (N06BA04); Atomoxetine (ATC code: N06BA09) ; Dexamfetamine (N06BA02) ; Guanfacine (C02AC02)
• Study drug International non-proprietary name (INN) or common name:
  ATOMOXETINE

  GUANFACINE HYDROCHLORIDE

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

  guanfacine

  (N06BA02) dexamfetamine

  dexamfetamine

  (N06BA04) methylphenidate

  methylphenidate

  (N06BA09) atomoxetine

  atomoxetine

  (N06BA12) lisdexamfetamine

  lisdexamfetamine
• Medical condition to be studied:
  Attention deficit hyperactivity disorder
• Additional medical condition(s):
  ADHD

Population studied

• Short description of the study population:
  Population-level utilisation of ADHD medications: general population.; All people aged 3 years and older (Rocco et al. 2021), registered in the respective databases since the 1st of January of 2010 to the latest available data, with at least 365 days of prior data availability, will participate in the population-level analysis of period prevalence and incidence of ADHD medications of interest. ; Patient-level utilisation of ADHD medications: new user cohort.; In objective 3 and 4, new user cohort of each ADHD medication will be created at drug substance level, using 365 days washout window. ; In objective 5 and 6, new users will be identified using the first record of any of the ADHD medications of interest within the study period, having no previous records for ANY study medication any time prior to entry. The index date will be defined as the date of the first eligible medication record. ; Five new user cohorts of the medications licensed for ADHD treatment will be constructed separately: the stimulants dexamphetamine, lisdexamfetamine, and methylphenidate, and the non-stimulants atomoxetine and guanfacine.
• Age groups:
  Paediatric Population (< 18 years)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adult and elderly population (≥18 years)

  Adults (18 to < 65 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Elderly (≥ 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)

Study design details

• Study design:
  Cohort studies will be conducted using routinely collected health data from 6 databases. The study will comprise two consecutive parts (see protocol).
• Setting:
  This study will be conducted using routinely collected data from 6 databases in 5 European countries. All databases were previously mapped to the OMOP CDM.

Documents

Study report

DARWIN EU_Report_P3-C1-004_ADHD_V5.pdf