Database Linkage Study to Evaluate the Risk of Medullary Thyroid Carcinoma

Study type

• Study topic:
  Disease /health condition

  Other
• Study topic, other:
  Pharmacoepidemiology / Drug Safety and Risk Assessment
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Secondary use of data

Study drug and medical condition

• Medicinal product name:
  BYDUREON

  VICTOZA

  SAXENDA

  TRULICITY

  OZEMPIC

  WEGOVY

  RYBELSUS

  MOUNJARO
• Medicinal product name, other:
  Bydureon Bcise, Tanzeum, Zepbound
• Study drug International non-proprietary name (INN) or common name:
  EXENATIDE

  LIRAGLUTIDE

  ALBIGLUTIDE

  DULAGLUTIDE

  SEMAGLUTIDE

  TIRZEPATIDE
• Anatomical Therapeutic Chemical (ATC) code:
  (A10BJ01) exenatide

  exenatide

  (A10BJ02) liraglutide

  liraglutide

  (A10BJ04) albiglutide

  albiglutide

  (A10BJ05) dulaglutide

  dulaglutide

  (A10BJ06) semaglutide

  semaglutide

  (A10BX16) tirzepatide

  tirzepatide
• Medical condition to be studied:
  Medullary thyroid cancer

Study design details

• Study design:
  This is a database linkage study with an active comparator new user study design
• Main study objective:
  The primary objectives are to:;  estimate the incidence of MTC among adults (18 years of age and older) in the US (hereafter referred to as adult patients) who are exposed to LA GLP-1 RA therapies, as compared to adult patients initiating an active comparator medication using IRRs and 95% CIs, and;  characterize adult patients exposed to LA GLP-1 RA therapies, and active comparator cohorts using demographic and other clinical characteristics, including selected prescription medications dispensed during the baseline period, and duration of LA GLP-1 RA therapy use.; ; The secondary objective is to:;  evaluate trends in the annual incidence of MTC in adult patients in the US for identification of any possible increase related to the introduction of LA GLP-1 RA therapies, into the US market.;
• Comparators:
  T2D Active Comparator 1 Cohort:;  ≥1 dispensed prescription for any sodium-glucose transport protein 2 (SGLT2) or; dipeptidyl peptidase IV (DPP-4) inhibitors during the study patient selection period.; T2D Active Comparator 2 Cohort:;  ≥1 dispensed prescription for any ADM, other than LA GLP-1 RA therapies, during the ; study patient selection period.; Overweight/obesity Active Comparator Cohort: ;  ≥1 dispensed prescription for any AOM, other than LA GLP-1 RA therapies, during the ; study patient selection period.