DARWIN EU® – Drug Utilisation Study of terbinafine-containing products

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:
  Terbinafine
• Study drug International non-proprietary name (INN) or common name:
  TERBINAFINE
• Anatomical Therapeutic Chemical (ATC) code:
  (D01AE15) terbinafine

  terbinafine

  (D01BA02) terbinafine

  terbinafine
• Medical condition to be studied:
  Dermatophytosis

  Fungal infection

Population studied

• Short description of the study population:
  For calculation of incidence rates of terbinafine-containing product use, the study population will include the general population (objective 1).; Inclusion criteria: ; • All individuals present in the data source between 1 January 2015 and 31 December 2024 (or latest available date).; • At least 1 year of data visibility prior to the index date.; Exclusion criteria:; • Children aged <1 year at any time during the study period.; For characterisation of terbinafine treatment initiators (objectives 2), estimation of treatment utilisation (objective 3), and description of treatment patterns (objective 4), the study population will include individuals with a first recorded prescription of a terbinafine-containing product prescription during the study period.; Inclusion criteria: ; • First record of a terbinafine-containing product between 1 January 2015 and 31 December 2024 (or latest available date).; • At least 1 year of data visibility prior to the index date.; • No use of terbinafine products in previous 180 days.; Exclusion criteria:; • Children aged <1 year at the index date.; • Individuals initiating terbinafine treatment <1 year before the end of data availability in the respective data source (to ensure sufficient follow-up).; Additionally, for estimation of treatment utilisation (objective 3), multiple treatment episodes will be considered.; Inclusion criteria: ; • New record of a terbinafine-containing product between 1 January 2015 and 31 December 2024 (or latest available date).; • At least 1 year of data visibility prior to the index date.; • No use of terbinafine products 180 days before each treatment episode.; Exclusion criteria:; • Children aged <1 year at the index date.; • Individuals initiating terbinafine treatment <1 year before the end of data availability in the respective data source (to ensure sufficient follow-up).;
• 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 retrospective cohort study will be conducted using routinely collected health data from 7 data sources from 6 countries across Europe and in 5 EU member states.
• Main study objective:
  1. To calculate the monthly and annual incidence of terbinafine use, overall and stratified by age and sex.; 2. To characterise patients at the time of terbinafine treatment initiation in terms of i) demographics, ii) indication for use, iii) comorbidities, iv) antifungal and antibiotic treatments (6, 3, and 1 month prior to treatment initiation and 6 months following initiation for antifungal treatment), and v) disease code for resistance (6 months before and 6 months after treatment initiation). ; 3. To report the number of treatment initiations, dose (initial, cumulative), and duration of terbinafine use, overall and stratified by type of dermatophytosis. ; 4. To explore the treatment pattern following each terbinafine treatment initiation, overall and by type of dermatophytosis, including transitions between topical to systemic and combination therapies.