DARWIN EU® - Association between aliskiren use and the incidence of cardiac arrhythmia and/or sudden death

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

• Medicinal product name, other:
  Aliskiren
• Medical condition to be studied:
  Sudden death
• Additional medical condition(s):
  Cardiac arrhythmia

Population studied

• Short description of the study population:
  Inclusion criteria; • Present in the period of 01/01/2007–31/10/2025 (or the end of available data); • At least one aliskiren prescription or dispensing record; • At least one record of any event included in the composite outcome consisting of cardiac arrhythmia (atrial fibrillation, atrial arrhythmias other than atrial fibrillation, or ventricular arrhythmias) or sudden death (sudden or unexplained death, sudden cardiac death, or unattended death); Exclusion criteria; • Missing information on age or sex ; • Less than 365 days of data availability prior to first aliskiren prescription or dispensing record;
• 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 SCCS will be conducted using routinely collected health data from 4 data sources from 2 European Union (EU) member states
• Main study objective:
  The objective of this study is to identify and characterise aliskiren users with cardiac arrhythmia and/or sudden death during the study period of 2007–2025, and to estimate the risk of cardiac arrhythmia and/or sudden death by calculating incidence rate ratio in different risk periods relative to the unexposed baseline period