Risk of Hypertension, Acute Myocardial Infarction, and Stroke in Migraine Patients Treated With Migraine Preventive Medications (20200403)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Observational retrospective study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  ERENUMAB

  FREMANEZUMAB

  GALCANEZUMAB

  EPTINEZUMAB
• Medical condition to be studied:
  Migraine

  Hypertension

  Acute myocardial infarction

  Cerebrovascular accident

Population studied

• Short description of the study population:
  The study included four migraine-related cohorts using data from the MarketScan Commercial and Medicare Supplemental medical claims database. The cohorts included patients aged 18-64 with migraines, using erenumab-aooe, other mAbs targeting the CGRP pathway, standard of care migraine preventive medications, and onabotulinumtoxinA from 17 May 2018 to 31 May 2020.; Inclusion Criteria:; 1. 18-64 years of age on the index date.; 2. One year of continuous enrollment (ie, complete medical and pharmacy coverage) prior to and including the index date, which defines the baseline period.; 3. A diagnosis of migraine during the baseline period, based on one of the following criteria:; a) ≥1 inpatient claim with a diagnosis of migraine (ICD-10-CM) diagnosis code of G43.xxx).; b) ≥1 outpatient evaluation and management claim with a diagnosis of migraine and a specialty code of 260 (neurologist).; c) ≥1 claim for emergency room visit with a diagnosis of migraine.; d) ≥1 outpatient evaluation and management claim with a diagnosis of migraine PLUS ³1 pharmacy fill for a migraine-specific triptan or an ergotamine class medication within 365 days of each other; e) ≥2 outpatient evaluation and management claims with a diagnosis of migraine between 7 and 365 days apart.; f) ≥2 pharmacy fills for migraine-specific triptans or ergotamine class medications between 7 and 365 days apart.; ; Exclusion Criteria:; (1) For the new user cohorts of mAbs targeting the CGRP pathway, no use of any medication targeting the CGRP pathway (erenumab-aooe, galcanezumab-gnlm, fremanezumab-vfrm, eptinezumab-jjmr, ubrogepant, rimegepant) in the year prior to the index date.; (2) For the SOC migraine preventive medications (anti-epileptics) new user cohort, no use of any of the migraine preventive anti-epileptics: (topiramate, valproic acid, divalproex sodium), or any medication targeting the CGRP pathway in the year prior to the index date.; (3) For the onabotulinumtoxinA new user cohort, no use of any onabotulinumtoxinA or any medication targeting the CGRP pathway in the year prior to the index date.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with hypertension, myocardial infarction and stroke
• Estimated number of subjects:
  56000

Study design details

• Main study objective:
  To describe baseline characteristics of four cohorts of migraine patients initiating a migraine preventive treatment: erenumab-aooe, other mAbs targeting the CGRP pathway, selected SOC migraine preventive medications (anti-epileptics), and onabotulinumtoxinA.
• Outcomes:
  Incidence of Hypertension, Acute MI, and Stroke in migraine patients treated with erenumab-aooe, other mAbs targeting the CGRP pathway, selected SOC migraine preventive medications (anti-epileptics), and onabotulinumtoxinA. Also to separately compare the cumulative incidence of select negative control outcomes in those patient groups.
• Data analysis plan:
  For the primary analysis, we will describe baseline patient characteristics, and estimate the risk of three CV outcomes (hypertension, stroke, acute MI) in the following four new user cohorts: (1) erenumab-aooe, (2) other mAbs targeting the CGRP pathway, (3) select anti-epileptic medications, and (4) onabotulinumtoxinA. If appropriate based on comparability analyses, we will also separately compare the risk of acute MI and stroke in patients treated with erenumab-aooe to the risk in each of the other three medication cohorts.