Evaluation of the Effectiveness of Risk Minimization Measures: Trimetazidine Drug Utilization Study in European Countries using databases – analysis for France, Hungary, Romania and Spain

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 use of data

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

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

  TRIMETAZIDINE DIHYDROCHLORIDE
• Medical condition to be studied:
  Angina pectoris

Population studied

• Short description of the study population:
  ENT specialists, ophthalmologists, cardiologist and GPs/other who has prescribed Trimetazidine.
• Age groups:
  • Paediatric Population (< 18 years)

    • Neonate

      • 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)
  • 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:
  1500

Study design details

• Main study objective:
  The primary objective is to Assess, per country, the proportion of prescriptions of TMZ for ophthalmological or ENT diagnoses (within the scope of its past indications) among the total prescriptions of TMZ after the restriction of its indications.
• Data analysis plan:
  The statistical analysis will be conducted using SAS® software Version 9.3 for Windows™ (SAS Institute, North Carolina, USA).The analysis will include descriptive statistics. Interrupted time series (ITS) analysis will be conducted if the conditions are met.The number of missing data will be indicated. Missing data will not be replaced by imputation methods. The statistical unit will be the prescription (for extractions from PI) or the dispensed prescription (for extractions from NDI and NPA database).Prescribers’ profile will be described per country: age, gender, speciality and region. Summaries will be reported at country level and by period (reference period and assessment period) categorized according to the speciality.