Incidence of Pancreatic Malignancy and Thyroid Neoplasm in Type 2 Diabetes Mellitus Patients who Initiate Exenatide Compared to Other Antihyperglycemic Drugs. (B015)

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 use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  EXENATIDE
• Medical condition to be studied:
  Type 2 diabetes mellitus

Population studied

• Short description of the study population:
  Patients included in the Life Sciences Research Database (LSRD) or the Impact database with at least 9 months of continuous enrollment in the underlying health insurance plan between 01 September 2004 and 31July 2010. Patients were eligible for cohort entry starting on 01 June 2005 (the date of exenatide launch).; Patients who had complete medical and pharmacy benefits and 9 months of continuous enrollment in the health plan prior to cohort entry date, and had a diagnosis of T2D (ICD-9-CM 250.x0, 250.x2) during the 9-month baseline period, inclusive of the cohort entry date, and had a dispensing of at least one antidiabetes drug other than the initiating drug during the 9-month baseline period, inclusive of the cohort entry date were included.
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Diabetes mellitus patients
• Estimated number of subjects:
  46623

Study design details

• Main study objective:
  The primary objective of this study was to estimate the absolute and relative incidence of newly diagnosed pancreatic and thyroid cancers among initiators of exenatide compared to matched initiators of other antihyperglycemic agents, overall and by duration of follow-up and drug exposure, assessing events one-year after drug initiation.
• Outcomes:
  The primary outcomes were newly diagnosed pancreatic cancer and thyroid neoplasm occuring at least one year following cohort entry. The secondary outcomes were newly diagnosed benign thyroid neoplasm, medullary thyroid carcinoma, and non-medullary thyroid carcinoma occuring at least one year following cohort entry.
• Data analysis plan:
  The outcomes of interest were identified on the basis of algorithms consisting of specific patterns of health insurance claims data. The algorithms were validated against a set of cases that were initially identified from the claims data and confirmed through medical chart review. Patients were followed for a new occurrence of pancreatic cancer or thyroid neoplasm from one-year after drug initiation to the end of follow-up period (31/12/2010) or disenrollment from the health plan. Two approaches were used to estimate the absolute and relative incidence of pancreatic cancer and thyroid neoplasm between the study cohorts. The first, a time-fixed analysis, categorized all follow-up time according to the initial exposure status (i.e. the patient's first dispensing). The second approach involved measuring cumulative dose and duration of exenatide exposure.