DARWIN EU® - Characterisation of aliskiren users

Study type

• Study topic:
  Human medicinal product
• 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:
  Aliskiren
• Study drug International non-proprietary name (INN) or common name:
  ALISKIREN

Population studied

• Short description of the study population:
  Inclusion criteria; • All individuals with an aliskiren prescription or dispensing record within the study period: 01/01/2007 to 31/12/2014, and from 01/01/2015 to 31/12/2024 (or the latest available date) ; Exclusion criteria; • Individuals starting first ever aliskiren with less than 365 days prior database history ;
• Age groups:
  • In utero
  • 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)
  • 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:
  A cohort study will be conducted using routinely collected health data from 4 databases from 4 countries across Europe and in 3 EU member states.
• Main study objective:
  1. To characterise new aliskiren users in terms of demographics, comorbidities, duration of use, and potential indications for aliskiren use, overall and stratified by age and by sex, during the study period of 2007–2014 and 2015–2024.; 2. To assess the use of co-medication, both prior to and after new aliskiren treatment initiation, overall and stratified by age and by sex, during the study period of 2007–2014 and 2015–2024.; 3. To estimate the number of people with both at least one aliskiren prescription/dispensation record(s) and a record of pre-specified cardiac events anytime during the study period of 2007–2014 and 2015–2024 (cross-cohort counts), overall and stratified by age and sex.;