Strattera patient exposures and adherence in the United Kingdom, Germany, the Netherlands, and Sweden: 2018 Bi-annual assessment report (B4Z-MC-B026)

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 with Strattera in the United Kingdom (UK), Germany, the Netherlands, and Sweden from the time period of 2012 through 2016.
• Age groups:
  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)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  37314

Study design details

• Main study objective:
  The main 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 5 calendar years. Counts and proportions will be tabulated by country, year, age group, gender, and formulation (capsule/oral solution). Patient exposures, including treatment duration, daily average dose, and frequent comorbid diagnoses will be presented (where available). Measures of utilization will be described for new users within the most recent 24 month follow-up for capsule users and 18 month follow-up for oral solution users. This includes: 1) percentage of patient discontinuation, reinitiation, and adherence, 2) mean and median length of therapy, as well as daily dose, and 3) distribution of the percentage of patients having undergone one or more recent treatment episodes over the follow-up period. Descriptive statistics will include patient count/frequencies by age, gender and formulation. Common comorbidities and concomitant medications will be summarized.

Documents

Study results

B026 PASS_Redacted (1)