Risk of 4 obesity-related cancers after GLP-1 receptor agonist use

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (A10BJ) Glucagon-like peptide-1 (GLP-1) analogues

  Glucagon-like peptide-1 (GLP-1) analogues
• Medical condition to be studied:
  Endometrial cancer

  Thyroid cancer

  Pancreatic carcinoma

  Prostate cancer

Population studied

• Short description of the study population:
  People with Type 2 Diabetes at least 50 years of age with prior cardiovascular disease of other risk factors for CVD.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Study design details

• Study design:
  This non-interventional study is aiming to emulate the LEADER trial using causal inference methodology on healthcare claims data
• Main study objective:
  This emulation aims to replicate the exposures and eligibility criteria of the LEADER trial, which randomized patients with diabetes and high cardiovascular risk to liraglutide or placebo and evaluated the outcome of major adverse cardiovascular events (MACE). This study will benchmark results for the MACE outcome against the LEADER trial, expand to evaluate the cancer outcomes of interest, and expand the treatment group to include new users of any GLP-1RA.
• Comparators:
  The control group consists of new users of DPP4 inhibitors (DPP4i), as an active comparator to emulate placebo assignment from the LEADER trial.
• Outcomes:
  Primary: Incident diagnosis of ; 1) Endometrial cancer ; 2) Thyroid cancer ; 3) Pancreatic cancer ; 4) Prostate cancer