Monitoring the effectiveness of risk minimisation in patients treated with pioglitazone-containing products

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (A10BD05) metformin and pioglitazone

  metformin and pioglitazone

  (A10BD09) pioglitazone and alogliptin

  pioglitazone and alogliptin

  (A10BG03) pioglitazone

  pioglitazone

Population studied

• Short description of the study population:
  Patients treated with pioglitazone-containing products from Denmark, Netherlands and UK.
• 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:
  10000

Study design details

• Main study objective:
   Objective 1: To provide observational data on drug utilisation patterns of pioglitazone-containing products in the European Union (EU) and to study associations between changes in drug utilisation patterns and the regulatory decisions in the form of DHPC. Objective 2a: To analyse events in patients discontinuing pioglitazone after the DHPC, including adverse drug events
• Outcomes:
  changes in drug utilizatonchanges in objective parameters of disease in response to labeling change
• Data analysis plan:
  Changes of drug utilization patterns overall and in patient groupsChanges of objective disease parameters in patients continuing and stopping containing products

Documents

Study results

D5.a Interim report on the study results

D5b D1 D2 Final report on study results_final version

Study report

D5.a Interim report on the study results (Appendix 2)