DARWIN EU® - Drug utilisation study of intramuscular depot olanzapine

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:
  ZYPADHERA
• Study drug International non-proprietary name (INN) or common name:
  OLANZAPINE
• Anatomical Therapeutic Chemical (ATC) code:
  (N05AH03) olanzapine

  olanzapine

Population studied

• Short description of the study population:
  All Objectives; Inclusion criteria; • Present between 01/01/2018 to 6 months before study period ends within each data source ; • Minimum 365 days of available history before index date ; Exclusion criteria; • Missing information on age or sex; Objective 2 and 3: Initial dose and maintenance dose of intramuscular depot olanzapine use, and monthly prevalence of intramuscular depot olanzapine discontinuation; Inclusion criteria; • Start of intramuscular depot olanzapine treatment era between 01/01/2018 to 6 months before study period ends within each data source ; Exclusion criteria; • Presence of another intramuscular depot olanzapine treatment era within the prior 365 days; Objective 4: Report switching patterns for intramuscular depot olanzapine; Inclusion criteria; • End of intramuscular depot olanzapine new user treatment era between 01/01/2018 and 31/12/2025 (or the latest available date), of which the new user treatment era starts between 01/01/2018 to 6 months before study period ends within each data source; • With at least 42 [PV1.1][DM1.2][SL1.3]days individual’s future observation period after the end of treatment era ; Exclusion criteria; • Presence of another intramuscular depot olanzapine treatment era within the 365 days prior to the start of treatment era under assessment; ;
• 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

• Main study objective:
  1. To estimate monthly incidence of intramuscular depot olanzapine use since 2018; 2. To estimate the initial dose and maintenance dose of intramuscular depot olanzapine use; 3. To estimate monthly prevalence of intramuscular depot olanzapine discontinuation ; 4. To describe treatment switching pattern among those who discontinued intramuscular depot olanzapine;