A PHARMO Study on the Utilization of Pioglitazone in Clinical Practice in The Netherlands with Regard to Diabetic Treatment Regimen and Co-morbidities

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:
  Cohort

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:
  All diabetic patients in the PHARMO database who ever received ≥1 prescription for pioglitazone, alone or in a combination therapy with metformin, a sulfonylurea drug, other oral antidiabetic drugs, or insulin, between June 1999 and May 2012 for the analysis relating to objectives 1 and 2 (heart failure and comedication with insulin).
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Diabetes mellitus patients
• Estimated number of subjects:
  2238

Study design details

• Main study objective:
  To describe the utilization patterns of pioglitazone for the period up to and including August 31st, 2007, between September 1st, 2007 and September 30th, 2010, between October 1st, 2010 and July 31st, 2011, and after July 31st, 2011.
• Outcomes:
  To estimate the incidence and prevalence of heart failure in diabetic patients prescribed pioglitazone, both overall and stratified by insulin co-medication status. To describe the patients who were given pioglitazone despite the contraindications given on its label.
• Data analysis plan:
  The key demographics will be presented before and after each major change to theproduct information or other factors potentially affecting pioglitazone use (31 August 2007, September 2010, July 2011). The overall analysis will be performed using data from the entire study period, the stratified analysis will use data up to a change in concomitant insulin treatment: patients will be stratified based on index use of concomitant insulin use and will no longer be followed after a change in insulin treatment.

Documents

Study results

AD-4833-409B-RDS-2012-10-17