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Published on: May 16, 2022
Safety of Rimegepant in Adults with Migraine and Cardiovascular Risk Factors: Analysis of a Multicenter, Long-Term,
David True1, Kathleen Mullin2, Robert Croop3
1Clinvest Research, 909 E Republic Rd Building D 200, Springfield, MO, 65807, USA. david.true@clinvest.com.
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%).
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.
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