Post-authorisation Safety Study of Rimegepant in Patients with Migraine and History of Cardiovascular Disease in European Countries

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  VYDURA
• Study drug International non-proprietary name (INN) or common name:
  RIMEGEPANT
• Anatomical Therapeutic Chemical (ATC) code:
  (N02CD06) rimegepant

  rimegepant
• Medical condition to be studied:
  Migraine

  Cardiovascular disorder

Population studied

• Short description of the study population:
  The study population will include adults with migraine (Protocol Section 9.3.3.1) and history of CVD; ( Protocol Section 9.3.3.2) registered in each electronic health care data source who are on treatment; with a qualifying acute or preventive migraine medication ( Protocol Table 3) during the study period.
• Age groups:
  • Adult and elderly population (≥18 years)
• Estimated number of subjects:
  2500

Study design details

• Study design:
  This is a non-interventional population-based prospective cohort study using a prevalent newuser design.
• Main study objective:
  The study has 2 primary objectives:; 1. To evaluate whether treatment initiation with rimegepant versus treatment with other preventive treatment for migraine (either continuing the current treatment or initiating a new one) increases the risk of MACE in patients with migraine, with history of CVD, and who are being treated with preventive migraine therapies.; ; 2. To evaluate whether treatment initiation with rimegepant versus treatment with other acute treatment for migraine (either continuing the current treatment or initiating a new one) increases the risk of MACE in patients with migraine, with history of CVD, and who are being treated with acute migraine therapies.;
• Outcomes:
  Major adverse cardiovascular event (MACE), Individual components of major adverse cardiovascular event (MACE) including acute myocardial infarction, stroke, coronary heart disease death, cerebrovascular death, coronary bypass surgery, and coronary revascularization.
• Data analysis plan:
  Each research partner will conduct analyses separately within each data source, and results will be pooled via meta-analytic methods, if appropriate. ; The analysis will comprise 4 different steps: select the study population, assign exposure and define follow-up, describe the study cohorts and patterns of rimegepant use, and estimate exposure propensity scores. Stabilised propensity score weights will be used in the comparative analyses. Crude and adjusted incidence rates of MACE with their 95% CIs will be estimated using a Poisson regression model with robust estimation of variance. Cumulative incidence of MACE will be estimated using the Kaplan-Meier estimator for each of the 4 exposure groups. Finally, for each comparison, crude and adjusted RRs and risk differences will be estimated using the Kaplan-Meier estimator, and 95% CIs will be derived using bootstrap methods. Adjusted HRs will be estimated with a Cox model.