Strattera patient exposures and adherence in the United Kingdom, Germany, the Netherlands, and Sweden: 2014 Bi-annual assessment report

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

• Anatomical Therapeutic Chemical (ATC) code:
  (N06BA09) atomoxetine

  atomoxetine

Population studied

• Short description of the study population:
  All patients with filled prescriptions of Strattera for the longest available duration in each selected database. In order to be eligible for inclusion patients will need at least two consecutive filled prescriptions.
• Age groups:
  • 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)
• Special population of interest:
  Hepatic impaired

  Immunocompromised

  Pregnant women

  Renal impaired
• Estimated number of subjects:
  0

Study design details

• Main study objective:
  The objective of this study is to describe atomoxetine (Strattera) utilization patterns for patients treated in Germany, United Kingdom (UK), Sweden, and the Netherlands
• Outcomes:
  Patient exposuresPatient discontinuation and adherenceDescriptive statistics
• Data analysis plan:
  For each country, patient counts will be provided for the most recent 5 full calendar years, and the moving annual total (MAT) will be provided for midyear of the most recent year of available data, when appropriate. Patient exposures including treatment duration, duration of exposure, daily average dose, and frequent comorbid diagnoses will be presented (where available). Patient discontinuation and adherence will be described, including the percentage of patients reinitiating therapy and the percentage of patients remaining on therapy at monthly time intervals. This will include data on mean and median length of therapy as well as mean daily dose.Descriptive statistics including frequencies and proportions of patient count and demographics such as age and gender will be provided as well as frequencies and proportions for population characteristics such as common comorbidities and concomitant medication.