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

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• 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, other:
  CGRP antagonists
• Anatomical Therapeutic Chemical (ATC) code:
  (N02CD) Calcitonin gene-related peptide (CGRP) antagonists

  Calcitonin gene-related peptide (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.
• Outcomes:
  Outcomes of interest: ; • Erectile dysfunction: Incident events during the study period ; • Insomnia: Incident events during the study period ; • Hypertension: incident events during the study period (only clinical diagnosis will be considered and no measurements)
• Summary results:
  This study describes the use of CGRP antagonists in a real-world setting across 4 European countries. Most individuals newly initiating CGRP antagonists were females with a median age of 42-48. The most frequently prescribed drug was erenumab and median treatment duration (first drug era) ranged between one to seven; months. ; While no formal comparisons were made, the (unadjusted) incidence rates of the outcomes of interest over the entire period were generally higher in individuals with incident migraine than in the general population. This difference was particularly high for insomnia, with incidence rates at least 2.5 times higher among those ; with incident migraine than in the general population. ; Incidence rates of the outcomes of interest across the different prophylactic treatment classes within one year following treatment initiation were consistently low for erectile dysfunction for all treatment classes. Hypertension rates showed the widest variability across classes, and rates were notoriously wide and highest among Beta-blocker initiators. Insomnia rates also varied across treatment classes, being highest among TCA.