Association between Pioglitazone and Bladder Cancer in a Medicare population

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (A10BB) Sulfonylureas

  Sulfonylureas

  (A10BG03) pioglitazone

  pioglitazone

  (A10BH) Dipeptidyl peptidase 4 (DPP-4) inhibitors

  Dipeptidyl peptidase 4 (DPP-4) inhibitors
• Medical condition to be studied:
  Type 2 diabetes mellitus

Population studied

• Age groups:
  • Adult and elderly population (≥18 years)

    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  150000

Study design details

• Main study objective:
  Examine the effect of initiation of pioglitazone relative to dipeptidyl-peptidase 4 inhibitors and/or sulfonylureas on the incidence of bladder cancer based on a new-user active comparator design.
• Outcomes:
  Incidence of invasive and in situ bladder cancer
• Data analysis plan:
  New users of pioglitazone(PIO) will be compared with new users of dipeptidyl-peptidase 4 inhibitors(DPP) or sulfonylureas(SU) with respect to incidence of bladder cancer. Propensity score weighting will be used to create pseudo-populations in which all baseline risk factors are balanced between each of the comparison cohorts (PIO vs DPP and PIO vs. SU). The date of dispensing of a second prescription within each exposure group will serve as the cohort entry date and the start of follow-up. The primary ‘as-treated’ analysis, will follow patients until the outcome occurs or the date of first occurrence of death, end of study (31 Dec 2013 2014 data may be added if it becomes available), end of enrollment, or change in therapy (discontinuation, switch, or augment). An additional ‘intention to treat’ analysis will follow patients without regard for change in therapy. See full protocol for additional details and description of secondary and sensitivity analyses.