A Study on the Utilization of Pioglitazone in Clinical Practice With Regard to Diabetic Treatment Regimen and Comorbidities

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

Study drug and medical condition

• Name of medicine:
  ACTOS
• Medical condition to be studied:
  Type 2 diabetes mellitus

Population studied

• Short description of the study population:
  Patients with pioglitazone use where most patients were between 50 and 79 years of age having type 2 diabetes mellitus along with comorbidities like hypertension and ischaemic heart disease.
• Age groups:
  • 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Diabetes mellitus patients
• Estimated number of subjects:
  32947

Study design details

• Main study objective:
  The goal of this study is to describe the prescription of pioglitazone in diabetic patients according to Summary of Product Characteristics, and to evaluate the implementation of the risk minimisation measures introduced in July 2011 regarding bladder cancer, heart failure, and the need for regular review of the benefits of therapy.
• Outcomes:
  To describe trends in pioglitazone prescription patterns over time, before and after the key risk minimization milestones, To estimate the prevalence and incidence of HF in diabetic patients using pioglitazone, overall and stratified by insulin co-medication.
• Data analysis plan:
  For all patients who ever received >= 1 prescription for pioglitazone, we will assess their age at first use, gender, body mass index, smoking status and the year in which the pioglitazone treatment was started, as well as concomitant drug use in the 12 months prior to starting pioglitazone, concomitant drug use after starting pioglitazone, and comorbidities at treatment initiation based on the entire available recorded patient history prior to starting pioglitazone.