Drug utilization study with VYVANSE® (lisdexamfetamine dimesilate) in Australia for Binge Eating Disorder

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Combined primary data collection and secondary use of data

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N06BA12) lisdexamfetamine

  lisdexamfetamine
• Medical condition to be studied:
  Binge eating

Population studied

• Short description of the study population:
  Patients who are prescribed VYVANSE® and describe prescribing patterns of VYVANSE® among physicians in Australia.; ; Patients must meet the following inclusion criterion and not meet the follow exclusion criterion to be eligible for the analysis:; Inclusion criterion:; o Physician entered data for the patient until at least question 3 (Q03; main indication).; Exclusion criterion:; o Physician entered ADHD as main indication for prescription of VYVANSE® (Q03) for the patient.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Estimated number of subjects:
  150

Study design details

• Main study objective:
  The overall objective is to provide data on an annual basis for 3 years in Australia to evaluate drug utilization of VYVANSE® with a special interest in BED and to monitor off-label use
• Outcomes:
  1.Number of Participants Based on Indication of Use of Lisdexamfetamine Dimesylate, 1.Number of Participants Based on Patterns of Drug Use 2.Number of Participants Based on Average Daily Dose 3.Number of Participants Based on Maximum Daily Dose 4.Number of Participants Based on Co-prescription 5.Number of Participants Based on Co-diagnosis 6.Number of Prescriptions of Lisdexamfetamine Dimesylate 7.Treatment Duration
• Data analysis plan:
  Over the assessment period of three years, prescriptions recorded in the NostraData database from each 12-month reporting period as well as from the complete period at that time will be analysed using descriptive statistics.

Documents

Study results

SHP489-827-clinical-study-report-redact