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European countries, using cross sectional analysis, to assess the extent of prescriptions of trimetazidine for its withdrawn ophthalmological and ENT indications among general practitioners, ophthalmologists and ENT specialists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

• EU PAS number:
  EUPAS18049
• Study ID:
  18050
• Official title and acronym:
  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five European countries, using cross sectional analysis, to assess the extent of prescriptions of trimetazidine for its withdrawn ophthalmological and ENT indications among general practitioners, ophthalmologists and ENT specialists
• DARWIN EU® study:
  No
• Study countries:
  France

  Greece

  Poland

  Romania

  Spain
• Study description:
  The aim of the study was to verify the compliance of prescribers regarding the restricted indication of trimetazidine after marketing authorisation changes in 2012. The primary objective was to assess, per country, the proportion of prescriptions of trimetazidine for ophthalmological or ENT diagnoses (within the scope of its past indications) among the total prescriptions of trimetazidine after the restriction of its indications.
• Study status:
  Finalised

Research institutions and networks

Institutions

Real World Evidence Solutions, IMS Health

France

Study timelines

Date when funding contract was signed

Actual: 27/09/2012

Study start date

Planned: 01/12/2012

Actual: 01/12/2012

Data analysis start date

Planned: 01/07/2014

Actual: 01/07/2014

Date of final study report

Planned: 30/09/2014

Actual: 10/12/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Les Laboratoires Servier

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)