{
  "abstract": "Objective This real-world analysis assessed the incidence over time of cardiovascular and cerebrovascular events among individuals taking rimegepant, using post-marketing data obtained from periodic safety update reports (PSURs).Methods Reports of cardiovascular or cerebrovascular adverse drug reactions were extracted from four rimegepant 6-monthly PSUR covering the 2-year period 27 February 2022 through 26 February 2024. Events were coded using Medical Dictionary for Regulatory Activities (MedDRA) version 25.0 through 26.1 and categorized using Standardized MedDRA Queries (SMQs) for cardiovascular and cerebrovascular events.Results Exposure to rimegepant was estimated at 305,632 patients during the first 6-month interval and 35,999 patient-years in the fourth 6-month interval. Over the 2-year period, there were 78 patients with cardiovascular events and 27 patients with cerebrovascular events identified. Incidence of cardiovascular and cerebrovascular events remained stable and very low during the 2-year period.Conclusions There was no new safety signal for cardiovascular or cerebrovascular events associated with rimegepant. Routine pharmacovigilance is ongoing, including a Post Authorization Safety Study in patients with cardiovascular disease. The latest Pharmacovigilance Risk Assessment Committee assessment at EMA requested monitoring requirements for rimegepant be eased from bi-annual to annual PSURs, without need for cardiovascular and cerebrovascular safety data presentation at this time.grant.oneil@pfizer.com",
  "authors": [
    {
      "affiliations": [
        "Pfizer Healthcare Ireland, Dublin"
      ],
      "name": "Chan Anthony"
    },
    {
      "affiliations": [
        "Pfizer RandD, Groton"
      ],
      "name": "Founraine Robert J"
    },
    {
      "affiliations": [
        "Pfizer Ltd., Tadworth"
      ],
      "name": "Pawinski Robert"
    },
    {
      "affiliations": [
        "Pfizer RandD, Groton"
      ],
      "name": "Pixton Glenn"
    },
    {
      "affiliations": [
        "Pfizer Ltd., Tadworth"
      ],
      "name": "Straghan Esther"
    }
  ],
  "title": "155 Cardiovascular and cerebrovascular events during treatment of migraine with rimegepant: analysis of post-authorization safety data",
  "uid": "6844ef59-b54f-5fac-b6a5-a15a162236b3"
}