Drug utilisation study (DUS) on flupirtine-containing medicinal products

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

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N02BG07) flupirtine

  flupirtine

Population studied

• Short description of the study population:
  All outpatients in Germany with a record of either single or recurrent use of Flupirtine prescription during the defined 12-month periods (patient selection window) identified from IMS® Disease Analyzer.
• 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:
  10000

Study design details

• Main study objective:
  Assessment of prescribing and Treatment Patterns of flupirtine-containing medical products during Routine use in the out Patient Settings before and after the Revision of SmPC.
• Outcomes:
  - Main reason for prescription- Amount of patients contraindicated for the use of NSAIDs/weak Opioids- Treatment Duration- Share of single/repeated prescriptions- Lenght of Treatment episodes- Amount of Liver Function Test- Concomitant Treatment and diseases
• Data analysis plan:
  Descriptive Analysis showing Treatment Patterns and main reason for prescription.No statistical testing.Data source is represetative IMS Disease Analyzer database Panel General practicioner and orhtopaedists.