Risk factors and incidence of inpatient constipation and inpatient constipation with serious complications among migraine patients treated with erenumab: A retrospective cohort study in a US Electronic Health Record Database (20200087)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Retrospective, Electronic Health Record database

Study drug and medical condition

• Name of medicine:
  AIMOVIG
• Medical condition to be studied:
  Migraine

Population studied

• Short description of the study population:
  The study population will include patients with a migraine diagnosis on or prior to receiving a prescription order for erenumab identified from 17 May 2018 through 30 June 2019 (or latest available data). Patients receiving erenumab will be identified using National Drug Codes (NDC) as recorded in the prescription order table within the EHR database. Migraine patients will be identified using a combination of ICD-10-CM migraine diagnosis codes (G43.-) and acute migraine-specific medication (triptans or ergots). To be included, patients must be at least 18 years or older at the time of the erenumab prescription order and have at least one outpatient clinical visit at least one year prior to the index date to establish baseline medications, risk factors, and patient characteristics. The minimum time requirement for establishing baseline factors may change due to sample size considerations. We will examine the number of patients who have a visit at least 6, 9, and 12 months prior to their index date. The index date will be defined as the date of the earliest prescription order for erenumab that meets all these criteria.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 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:
  Migrane patients
• Estimated number of subjects:
  18941

Study design details

• Main study objective:
  1. To describe risk factors of inpatient constipation and inpatient constipation with serious complications among migraine patients treated with erenumab. 2. To estimate the cumulative incidence proportion of inpatient constipation and inpatient constipation with serious complications among migraine patients treated with erenumab.
• Outcomes:
  The cumulative incidence proportion of inpatient constipation and inpatient constipation with serious complications
• Data analysis plan:
  Risk of inpatient constipation (IC) (and the subset with serious complications) among the erenumab cohort will be described overall and stratified by the presence/absence of gastrointestinal conditions or other comorbidities in the baseline period. The erenumab cohort will be described by frequencies and percentages according to demographics and other baseline risk factors. Counts of IC events (and the subset with serious complications) observed starting from the day after index date through the end of study period (or switching to another anti-CGRP) will be tabulated. Only the first observed IC event will be counted. The cumulative incidence proportion of IC (and the subset with serious complications) will be calculated as the number of events identified during follow-up divided by the number of patients at risk for the event (along with 95% confidence intervals). Study results will be applicable to migraine patients initiating erenumab in the United States.

Documents

Study results

01.47.01.01 Observational Research Study Report Published Report_Abstract (2020087)_Redacted