Estimating Event Rates Using the Medication Cohort Module: Hypertension and Negative Control Outcomes in New Users of Onabotulinumtoxin A and Monoclonal Antibodies Targeting the Calcitonin-Gene-Related Pathway in the Marketscan EarlyView Claims Database (20200218)

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

Study drug and medical condition

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

Population studied

• Short description of the study population:
  All migraine patients who were 18 years of age on the index date, had one year of continuous enrollment (ie, complete medical and pharmacy coverage) prior to the index date, had a diagnosis of migraine in the year prior to index, and were new users of erenumab-aooe, fremanezumab-vfrm, galcanezumab-gnlm, or onabotulinumtoxin A were eligible to be in the study. Patients were then followed from first use of one of these treatments through 31 January 2020 for the occurrence of any hypertension, serious hypertension, hypertensive crisis, road traffic accidents, falls, and influenza vaccination.
• 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:
  30000

Study design details

• Main study objective:
  This study will estimate event rates in four medication cohorts in an administrative claims database: new users of erenumab-aooe, new users of fremanezumab-vfrm, new users of galcanezumab-gnlm, and new users of onabotulinumtoxin A. The outcomes of interest include any hypertension, serious hypertension, hypertensive crisis, road traffic accidents, falls, and influenza vaccination.
• Outcomes:
  The outcomes of interest include any hypertension, serious hypertension, hypertensive crisis, road traffic accidents, falls, and influenza vaccination
• Data analysis plan:
  Event rates based on grouped data will be calculated as the number of events during the follow-up period divided by the total person-time at risk. All event rates will be presented per 1,000 person-years, and CIs for the event rates will be based on the Poisson distribution or approximations of the Poisson distribution for small sample sizes. The outcomes of interest include any hypertension, serious hypertension, hypertensive crisis, road traffic accidents, falls, and influenza vaccination.

Documents

Study results

EUPAS34832-40206