DARWIN EU® - RR Childhood hypertension and sartans prescribing in children

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name, other:
  Sartans drugs classes with corresponding WHO ATC code (classified at 4th level); ; Antihypertensive drug classes with corresponding WHO ATC code (classified at 2nd level)
• Anatomical Therapeutic Chemical (ATC) code:
  (C09CA) Angiotensin II receptor blockers (ARBs), plain

  Angiotensin II receptor blockers (ARBs), plain

  (C09DA) Angiotensin II receptor blockers (ARBs) and diuretics

  Angiotensin II receptor blockers (ARBs) and diuretics

  (C09DB) Angiotensin II receptor blockers (ARBs) and calcium channel blockers

  Angiotensin II receptor blockers (ARBs) and calcium channel blockers

  (C09DX) Angiotensin II receptor blockers (ARBs), other combinations

  Angiotensin II receptor blockers (ARBs), other combinations

  (C03) DIURETICS

  DIURETICS

  (C07) BETA BLOCKING AGENTS

  BETA BLOCKING AGENTS

  (C08) CALCIUM CHANNEL BLOCKERS

  CALCIUM CHANNEL BLOCKERS

  (C09) AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

  AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
• Medical condition to be studied:
  Hypertension

Population studied

• Short description of the study population:
  For prevalence calculations of CHT (objective 1), the study population will include all individuals who are 18 years or younger and registered in the data source between the 1st of January 2015 and 31st of December 2024 (or the latest data available of the respective data source).; For prevalence calculations of prescribing of sartans and other antihypertensive medications in patients with CHT (objective 2), the study population will include all individuals registered in the data source with a condition occurrence of CHT, defined as a SNOMED diagnostic code for hypertension, in individuals who are 18 years and younger, between the 1st of January 2015 and 31st of December 2024 (or the latest data available of the respective data source).
• Age groups:
  • Paediatric Population (< 18 years)

    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)

Study design details

• Study design:
  A cohort study will be conducted using routinely collected health data.
• Main study objective:
  The aim of this study is to assess the prevalence of childhood hypertension and of sartans and other antihypertensive medication prescribing among patients with childhood hypertension in European countries.; The specific objectives of this study are:; 1. To estimate the annual prevalence of childhood hypertension (CHT) in the paediatric population. Results will be stratified by age group (children vs. adolescents), sex, and type of hypertension (primary vs. secondary).; 2. To estimate the annual prevalence of sartans and other antihypertensive medication prescribing in patients with childhood hypertension (CHT). Results will be stratified by drug class, age group (children vs. adolescents), sex, and type of hypertension (primary vs. secondary).;
• Outcomes:
  Objective 1: ; The outcome for this objective is as follows: ; • Occurrence of CHT, defined as a recorded SNOMED diagnostic code for hypertension in individuals ; aged 18 years or younger.; Objective 2: ; The outcome for this objective is as follows: ; • Prescribing of pre-specified antihypertensive medication among individuals with CHT, defined as a ; recorded RxNorm prescription of pre-specified antihypertensive medication in individuals ; diagnosed with hypertension and aged 18 years or younger.; • Sartans (WHO ATC codes C09CA, C09DA, C09DB, C09DX) will be assessed per drug class at ; WHO ATC level 4. ; • Other pre-specified antihypertensive medication (WHO ATC codes C03, C07, C08, C09) will ; be assessed per drug class at WHO ATC level 2.