Incretin-based therapies and Pancreatic Cancer risk in Medicare enrollees – new user protocol

Study type

• Study topic:
  Disease /health condition

  Human medicinal product

  Other
• Study topic, other:
  Diagnostic procedures
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  BYDUREON

  BYETTA

  JANUVIA

  ONGLYZA

  VICTOZA
• Medical condition to be studied:
  Diabetes mellitus

Population studied

• Short description of the study population:
  Medicare enrollees > 65 years of age initiating Incretin-based drugs (IBRx) or other antidiabetic drugs (CompRx)
• Age groups:
  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:
  75000

Study design details

• Main study objective:
  The primary objective of this study is to examine the effect of initiation of incretin-based therapies (IBRx) relative to other anti-diabetic therapies (CompRx) on the incidence of pancreatic cancer based on a new-user active comparator design. A secondary aim is to evaluate the use of diagnostic procedures that may lead to a preclinical diagnosis of pancreatic cancer prior to and after initiation
• Outcomes:
  Incident pancreatic cancer, pancreatic cancer mortality, incidence of diagnostic work-up
• Data analysis plan:
  IBRx new-users will be compared with new users of CompRx with respect to incidence of pancreatic cancer diagnosis, pancreatic cancer mortality and incidence of diagnostic work-up. We will use propensity scores to balance measured risk factors for cancer/diagnostic work-up between these cohorts. Hazard rates for each of the outcomes will be estimated using a Cox proportional hazards model controlling for age and sex as well as any covariates remaining imbalanced after implementation of the propensity score. In addition, cumulative incidence of diagnostic work-up in the IBRx and CompRx groups across time before and after drug initiation will be examined. Please see full protocol for additional details and description of secondary and sensitivity analyses.

Documents

Study results

Summary of results_incretin manuscript