Oral Rimegepant 75 mg is Safe and Well Tolerated in Adults With Migraine and Cardiovascular Risk Factors: Results of a Multicenter, Long-Term, Open-Label Safety Study
Susan Hutchinson1, Jack Schim2, Richard Lipton3, Robert Croop4, Christopher Jensen4, Alexandra Thiry4, Elyse Stock4, Charles Conway4, Meghan Lovegren4, Vlad Coric4, Michael Hanna4
1Orange County Migraine & Headache Center, 2The Headache Center of Southern California, 3Albert Einstein College of Medicine, 4Biohaven Pharmaceuticals
Objective:

To evaluate the safety and tolerability of rimegepant in adults with CV risk factors.

Background:

Triptans are contraindicated or must be used with caution in ~3.5 million people with migraine due to cardiovascular (CV) safety concerns. Rimegepant is an orally administered small molecule CGRP receptor antagonist FDA-approved for the acute treatment of migraine that does not produce active vasoconstriction associated with triptans.

Design/Methods:

This was a multicenter, long-term, open-label safety study (NCT03266588) in adults with a history of 2-14 monthly migraine attacks of moderate to severe pain intensity. Subjects used rimegepant 75 mg up to once daily for up to 52 weeks. For this analysis, subjects were organized into subgroups by number of baseline CV risk factors (0, 1, ≥2) and Framingham 10-year risk of developing a CV condition (low = <10%, moderate to high = ≥10%).

Results:

Of the 1800 rimegepant-treated subjects, 59.2%, 28.8%, and 12.1%, respectively, had 0, 1, or ≥2 CV risk factors; 7.0% had a moderate to high 10-year CV risk. The most common AE, upper respiratory tract infection, occurred in <10% of subjects regardless of number of CV risk factors or 10-year CV risk. Serious AEs were reported by a similar proportion of subjects with 0, 1, or ≥2 CV risk factors (2.3-2.7%) and among those with low and moderate to high 10-year CV risk (2.4-2.6%); no SAEs were considered by the investigator to be related to rimegepant. Only 1 subject out of 1800, a 53 year old male with a history of CV disease (angina pectoris), experienced an ischemic Cardiac Disorder SOC AE (angina pectoris) deemed by the investigator to be not related to rimegepant.

Conclusions:
Rimegepant dosed up to once daily for up to 1 year showed favorable safety and tolerability in adults with migraine with CV risk factors, including adults with moderate to high CV risk.