NN2211-8841 Database Linkage Study to Evaluate the Risk of Medullary Thyroid Carcinoma

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  BYDUREON

  VICTOZA

  SAXENDA

  TRULICITY

  OZEMPIC

  WEGOVY

  RYBELSUS

  MOUNJARO
• 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

Population studied

• Short description of the study population:
  All eligible patients must fulfill the following requirements:;  ≥18 years or older during the year of index (date of qualifying medication);  In addition to index medication, ≥1 dispensed medication (any class) within 24 months prior to the; index date1;  ≥1 dispensed medication (any class) after the index date and within 12 months of index date (12-month; post-index period);  No evidence of cohort qualifying medication during 12-month before the index date;  Reside in the US, including the District of Columbia (DC) during the study period;  No missing values for year of birth; Patient eligibility for inclusion by study cohorts, in addition to the above criteria are captured below.; LA GLP-1 RA therapies exposed cohort:;  ≥ 1 dispensed prescription for a LA GLP-1 RA therapy during the study patient selection period; T2D Active Comparator 1 Cohort:;  ≥1 dispensed prescription for 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 antidiabetic medication, other than LA GLP-1 RA therapies, during; the study patient selection period; Overweight/Obesity Active Comparator Cohort:;  ≥1 dispensed prescription for any anti-obesity medication, other than LA GLP-1 RA therapies, during; the study patient selection period; Patients with a diagnosis of MTC in the linked SCR data before their index date will not be included in the; study.

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.;  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.