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  11. Safety Of Rimegepant In Adults With Migraine And Cardiovascular Risk Factors: Analysis Of A Multicenter, Long-term, Open-label Study

Safety of Rimegepant in Adults with Migraine and Cardiovascular Risk Factors: Analysis of a Multicenter, Long-Term, Open-Label Study

David True1, Kathleen Mullin2, Robert Croop3

  • 1Clinvest Research, 909 E Republic Rd Building D 200, Springfield, MO, 65807, USA. david.true@clinvest.com.

Pain and Therapy
|July 10, 2024

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View abstract on PubMed

Summary
This summary is machine-generated.

Rimegepant is a safe oral migraine treatment for patients with cardiovascular risk factors. This study found favorable safety and tolerability across various cardiovascular risk levels.

Area of Science:

  • Neurology
  • Cardiology

Background:

  • Cardiovascular (CV) risk factors can restrict migraine treatment choices.
  • Rimegepant, an oral calcitonin gene-related peptide receptor antagonist, does not cause vasoconstriction.
  • Assessing rimegepant's safety in patients with varying CV risk is crucial.

Purpose of the Study:

  • To evaluate the safety and tolerability of rimegepant in adult migraine patients with pre-existing cardiovascular risk factors.
  • To analyze safety data based on the number of CV risk factors and Framingham Risk Score.

Main Methods:

  • A phase II/III open-label safety study involved 1800 participants treating migraine with rimegepant 75 mg orally for up to 52 weeks.
  • Participants with uncontrolled, unstable, or recent CV disease were excluded.
  • Safety was assessed in subgroups based on CV risk factors (0, 1, ≥2) and Framingham Risk Score (<10%, ≥10%).
Keywords:
Calcitonin gene-related peptide receptor antagonistsCardiovascularMigraineRimegepant

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Main Results:

  • Adverse event (AE) and serious AE proportions were consistent across CV risk subgroups.
  • AEs leading to discontinuation were low across all risk categories.
  • The safety profile of rimegepant remained favorable regardless of cardiovascular risk level.

Conclusions:

  • Rimegepant demonstrates favorable safety and tolerability in adults with migraine and cardiovascular risk factors.
  • The drug is suitable for patients with moderate to high cardiovascular risk.
  • This supports rimegepant as a viable migraine treatment option for a broader patient population.
Risk factors
Safety