A study on the utilization of pioglitazone in clinical practice in the UK after the label change in July 2011

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

Study drug and medical condition

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

Population studied

• Short description of the study population:
  Prescription pattern of pioglitazone was evaluated in diabetic patients within the UK after the label change in July 2011.
• 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:
  14794

Study design details

• Main study objective:
  The overall aim of this DUS was to assess the effectiveness of the July 2011 labeling update for pioglitazone in clinical practice within the UK.
• Outcomes:
  To quantify the number of incident and prevalent users of pioglitazone in the UK after the label change on 21 July 2011. Duration of T2DM before treatment start with pioglitazone, Prevalent comorbidities and contraindications, Exposure duration to Pioglitazone
• Data analysis plan:
  We will establish 3 different models to assess the prescription pattern of pioglitazone,to learn more about drug utilization of incident and prevalent pioglitazone users after 21 July 2011. We will assess T2DM disease duration prior to treatment initiation with pioglitazone in incident users. Among incident pioglitazone users after 21 July 2011, we will quantify the proportion of patients with a history (i.e. a prevalent diagnosis) of hypertension, ischemic heart disease, myocardial infarction, chronic kidney disease (CKD, incl. dialysis), and chronic obstructive pulmonary disease (COPD) at the time of the first pioglitazone prescription, based on the entire available recorded patient history prior to starting pioglitazone.