Exposure to pioglitazone and the risk of prostate cancer: a nested case-control study

Study type

• Study topic:
  Disease /health condition

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

  Disease epidemiology
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Case-control

  Other
• Non-interventional study design, other:
  Nested, matched case-control study

Study drug and medical condition

• Medical condition to be studied:
  Type 2 diabetes mellitus

  Prostate cancer

Population studied

• Short description of the study population:
  Patients aged 40 years or older with type II diabetes mellitus and matched controls with prostate cancer identified from the Clinical Practice Research Datalink (CPRD) between 01 January 2001 and 05 January 2015.
• 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:
  Type 2 diabetes mellitus patients
• Estimated number of subjects:
  55000

Study design details

• Main study objective:
  The primary objective of the study is to investigate if there is an association between pioglitazone use and the risk of prostate cancer.
• Outcomes:
  Number of Participants Reporting Prostate Cancer Related to Pioglitazone. 1) Duration of Pioglitazone Exposure. 2) Cumulative Dose of Pioglitazone Exposure.
• Data analysis plan:
  Conditional logistic regression will be used to calculate the adjusted Odds Ratios (OR) of prostate cancer associated with use of pioglitazone.