DARWIN EU® - CGRP antagonists - Treatment patterns and users characteristics

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

Study drug and medical condition

• Name of medicine, other:
  CGRP antagonists
• Medical condition to be studied:
  Migraine

Population studied

• Short description of the study population:
  • Population of individuals newly initiating first treatment with any of the CGRP antagonists of interest (objectives 1 and 2).; • Population of individuals with newly diagnosed migraine (objectives 3 and 4). ; • General population, consisting of all individuals in the database with at least 365 days of database history (objective 5).

Study design details

• Study design:
  Patient-level drug utilisation study.
• Main study objective:
  The aim of this study is to characterise individuals treated with CGRP antagonists for migraine. ; ; The specific study objectives are: ; 1. Characterisation of patients newly treated with CGRP antagonists (i.e. new user cohort) in terms of demographics, risk factors for erectile dysfunction, insomnia, hypertension, and concomitant medications taken at index date. The characterisation will be stratified by sex. ; 2. Characterisation of treatment with CGRP antagonists in a cohort of new users in terms of duration of treatment.; 3. Incidence rate of erectile dysfunction, insomnia, and hypertension in a newly diagnosed migraine population (irrespective of treatment) stratified by age groups and sex.; 4. Incidence rate of erectile dysfunction, insomnia, and hypertension in a newly diagnosed migraine population initiating treatment with CGRP antagonists or other prophylactic treatments (anti-epileptics, TCA antidepressants, Beta-blockers, tricyclic antidepressants, calcium channel blockers), stratified by age groups and sex. ; 5. Incidence rate of erectile dysfunction, insomnia, and hypertension in the general population (as reference) stratified by age groups and sex
• Setting:
  This study will use routinely collected health data from 4 databases in the DARWIN EU® network of data partners from 4 European countries. All databases were previously mapped to the OMOP CDM.