Drug utilization study for Elvanse® / Tyvense® / Elvanse® Adult in Europe

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary data collection

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N06BA12) lisdexamfetamine
• Medical condition to be studied:
  Attention deficit hyperactivity disorder

Population studied

• Short description of the study population:
  Patients who have been prescribed Elvanse® / Tyvense ® at least once during the study period.
• Age groups:
  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)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with attention deficit hyperactivity disorder
• Estimated number of subjects:
  50000

Study design details

• Main study objective:
  Overall objective: The study’s objective is to provide data on an annual basis for the next 5 years in European countries to evaluate drug utilization. Study objectives:1. To characterize patients who are prescribed Elvanse®/Tyvense®2. To describe prescribing patterns of Elvanse®/Tyvense® among physicians3. To describe usage patterns of Elvanse®/Tyvense® among patients
• Data analysis plan:
  The analysis will be done descriptively as specified in the statistical analysis plan.

Documents

Study results

SHP489-813 Elvanse DUS Fifth R_FINAL_Watermarked

Study publications

Siffel C, Page M, Maxwell T, Thun B, Kolb N, Rosenlund M, von Bredow D, Keja J…