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

ABSTRACT

INTRODUCTION: Cardiovascular (CV) risk factors can limit treatment options for migraine. Rimegepant is an orally administered small-molecule calcitonin gene-related peptide receptor antagonist that does not induce vasoconstriction. The aim of these post hoc subgroup analyses was to assess the safety of rimegepant according to CV risk. METHODS: In a multicenter, long-term, open-label, phase II/III safety study, participants with a history of 2-14 migraine attacks per month of moderate or severe pain intensity self-administered rimegepant 75 mg, orally, to treat migraine up to once daily for up to 52 weeks. Uncontrolled, unstable, or recently diagnosed CV disease was part of the exclusion criteria. Safety was assessed across subgroups according to number of CV risk factors (0, 1, or ≥ 2) and Framingham Risk Score (< 10% or ≥ 10%). RESULTS: Of 1800 treated participants, 28.8% had one CV risk factor and 12.1% had ≥ 2 CV risk factors; 7.0% had Framingham Risk Score ≥ 10%. Across the subgroups with 0, 1, and ≥ 2 CV risk factors and Framingham Risk Score < 10% and ≥ 10%, respectively, proportions of participants reporting adverse events (AEs; 59.6%, 61.4%, 62.2%, 59.9%, 67.5%) and serious AEs (2.7%, 2.5%, 2.3%, 2.6%, 2.4%) were consistent, and AEs leading to study drug discontinuation were low (1.9%, 3.1%, 5.5%, 2.5%, 4.8%). CONCLUSIONS: Rimegepant showed favorable safety and tolerability in adults with migraine and CV risk factors, including those with moderate to high CV risk. TRIAL REGISTRATION ClinicalTrials.gov NCT03266588.

Older patients with migraine often have cardiovascular (CV) disease ­ such as a prior heart attack ­ or risk factors for CV disease. Examples of CV risk factors are high blood pressure, diabetes, smoking, high cholesterol, and a family history of heart disease. The choice of treatments for migraine is limited by safety concerns for patients who have CV risk factors. Newer treatments for migraine ­ including rimegepant ­ work differently than older drugs, by targeting calcitonin gene-related peptide. The safety of rimegepant for patients with migraine and CV risk factors can be studied in a clinical trial. In a long-term trial, patients with migraine took rimegepant tablets to treat migraine attacks, up to once a day, for up to 52 weeks. Some of the patients in the study had CV risk factors. We analyzed the results of the study by grouping the patients based on how many CV risk factors they had. We found that the side effects of rimegepant were similar across the groups. This showed that rimegepant was safe and well tolerated in adults with migraine and CV risk factors.