Pioglitazone Use and Risk of Bladder Cancer: a Systematic Review and Meta-Analysis of Observational Studies

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
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Systematic review and meta-analysis

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  PIOGLITAZONE HYDROCHLORIDE
• Medical condition to be studied:
  Bladder cancer

Population studied

• Short description of the study population:
  Type 2 diabetes mellitus patients with or without exposure to pioglitazone with the risk of developing bladder cancer.
• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  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:
  99999999

Study design details

• Main study objective:
  The primary research question is whether type 2 diabetes mellitus patients treated with pioglitazone are at a higher risk of bladder cancer compared to type 2 diabetes mellitus patients who are not treated with pioglitazone.
• Outcomes:
  Bladder cancer
• Data analysis plan:
  Hazard ratio will be the common measure of association that will be extracted from each study, or derived based on available data. Combined estimates will be derived using primarily a random-effects model and repeated secondarily using a fixed-effects model (sensitivity analysis).

Documents

Study results

Pioglitazone meta-analysis report abstract 2017-04-21