DARWIN EU® - Sex-specific incidence of selected adverse events for major cardio-metabolic drug classes

Study type

• Study topic:
  Disease /health condition

  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:
  HMG CoA reductase inhibitors (statins) (ATC C10AA); GLP-1 receptor agonists (ATC A10BJ); SGLT2 inhibitors (ATC A10BK);
• Anatomical Therapeutic Chemical (ATC) code:
  (C10AA) HMG CoA reductase inhibitors

  HMG CoA reductase inhibitors

  (A10BJ) Glucagon-like peptide-1 (GLP-1) analogues

  Glucagon-like peptide-1 (GLP-1) analogues

  (A10BK) Sodium-glucose co-transporter 2 (SGLT2) inhibitors

  Sodium-glucose co-transporter 2 (SGLT2) inhibitors

Population studied

• Short description of the study population:
  Inclusion criteria; • Present in the period of 01/01/2014 to 31/12/2025 (or the latest available date); • Minimum 365 days of available history before the index date ; • Drug prescription or dispensing record of the three classes of medication during the study period; • Aged >18 years at the index date; Exclusion criteria; • Prescription or dispensing of the drug any time prior to the index date; • Having experienced the outcomes of interest (for the index class) before the index date; • Initiated more than one ingredient from the same drug class on the index date
• Age groups:
  • 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 data sources from 6 countries across Europe
• Main study objective:
  1. Identify first time treatment initiators of any drug in the class and describe the characteristics at the time (age, potential indication for index drug, comorbidities, co-medication), stratified by sex.; 2. Estimate the incidence of each adverse outcome post first initiation for any drug in the class, stratified by sex and age group.;