Drug utilisation study, in five European countries, using cross sectional analysis, to assess the extent of prescriptions of trimetazidine for its withdrawn ophthalmological and ENT indications among general practitioners, ophthalmologists and ENT specialists

Study type

• Study topic:
  Disease /health condition

  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:
  Prescription event monitoring

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (C01EB15) trimetazidine

  trimetazidine
• Medical condition to be studied:
  Angina pectoris

Population studied

• Short description of the study population:
  Trimetazidine prescribed patients who consulted general practitioners, ophthalmologists and ENT specialists during the study periods in the five targeted countries.
• Age groups:
  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)
• Estimated number of subjects:
  1920

Study design details

• Main study objective:
  ­Assess, per country, the proportion of prescriptions of TMZ for ophthalmological and/or ENT diagnoses (within the scope of its past indications) among the total prescriptions of TMZ after the restriction of its indications.
• Outcomes:
  The primary end point was the proportion of TMZ prescriptions for ophthalmological and/or ENT diagnoses (within the scope of its past indications) among all TMZ prescriptions in the targeted prescribers of each country. Assess the extent of TMZ prescriptions: for ophthalmo or ENT diagnoses before and after the restriction of its indications by specialty (GPs, ophthalmo, ENT specialists), with regards to specialists’ characteristics, after the restriction of its indications by GPs in the cardiovascular indication and by GPs (FR, ES) for angina pectoris without other concomitant prescriptions for angina pectoris.
• Data analysis plan:
  The statistical analysis was conducted using SAS® software Version 9.2 for Windows ™ (SAS Institute, North Carolina, USA).Continuous variables were described by the number of valid cases, the number of missing values, mean, standard deviation, median, Q1, Q3 and range.Categorical variables were described as the total number and relative percentage per category. The number of missing data was indicated and missing data was not taken into account for the calculation of the percentages. Confidence intervals of 95% were calculated for each item, when relevant. The statistical unit was the prescription (for extractions from PI database) or the dispensed prescription (for extractions from NDI database). Calculations were performed on raw data. Prescribers’ profile was described per country: age, gender and region. Summaries were reported at country level and by period (Reference period and assessment period) categorized according to the speciality.