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.