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

Terbinafine

Study drug International non-proprietary name (INN) or common name

TERBINAFINE

Anatomical Therapeutic Chemical (ATC) code

(D01AE15) terbinafine
terbinafine
(D01BA02) terbinafine
terbinafine
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.