Strattera patient exposures and adherence in the United Kingdom, Germany, the Netherlands, and Sweden: 2016 Bi-annual assessment report. (B4Z-MC-B025)

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:
  Patients treated in the United Kingdom, Germany, the Netherlands, and Sweden from the time period of 2008 through 2014.
• 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:
  38152

Study design details

• Main study objective:
  The objective is to describe atomoxetine (Strattera) utilization patterns for patients treated in Germany, United Kingdom, Sweden, and the Netherlands.
• Outcomes:
  Patient exposures, patient discontinuation and adherence, and descriptive statistics
• Data analysis plan:
  For each country, patient counts will be provided for the most recent 7 full calendar years. Counts and proportions will be tabulated by country, year, age group, and gender.Patient exposures, including treatment duration, duration of exposure, daily average dose, and frequent comorbid diagnoses will be presented (where available).Measures of drug utilisation will be described for new users within the most recent 24 month follow-up period. This includes: 1) percentage of patient discontinuation, reinitiation, and adherence, 2) mean and median length of therapy, as well as daily dose, and 3) the distribution of the percentage of patients having undergone one or more treatment episodes over the 24 month observation period.Descriptive statistics including frequencies and proportions of patient count and demographics such as age and gender will be provided, as well as for population characteristics such as common comorbidities and concomitant medications.