Rapid Data Analysis (RDA) – Amfepramone drug utilisation

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:
  Other
• Non-interventional study design, other:
  Descriptive study of patients in general practices (GP)

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  AMFEPRAMONE

Population studied

• Short description of the study population:
  Patients in general practices (GP) receiving at least one prescription with amfepramone over the studied period.; Between January 1998 and June 2020 a total of 7204 patients in GP practices had 24,275 prescriptions (prescription dates) for amfepramone. Of these patients, 4825 had an incident prescription.
• Age groups:
  • Paediatric Population (< 18 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)
• Estimated number of subjects:
  4000

Study design details

• Main study objective:
  To evaluate drug utilisation trends and duration of treatment of amfepramone between 1 January 1998 to 30 June 2020, To evaluate the total long-term usage over the entire period of the cohort, To provide incidence rates for selected CV events in patients with no history of such events: Valvular disorders, Pulmonary heart disease, Cardiomyopathy, Heart failure, Essential (primary) hypertension.
• Data analysis plan:
  Descriptive analyses were performed to derive further insight regarding drug utilization trends and prescription duration of amfepramone use + Calculation of incidence rates and incidence proportions, see section 6.8.1 of the report