Rimegepant, an oral calcitonin gene-related peptide receptor (CGRP) inhibitor for migraine, had similar safety profiles across all cardiovascular risk groups, according to data presented at the 2021 virtual AAN Annual Meeting.
The findings further solidify the therapy as a good option for patients who have a high cardiovascular risk, the study authors said. Rimegepant is not vasoconstrictive, unlike triptans, which exert vasoconstriction and are contraindicated for people with coronary artery disease, unstable angina, and other cardiovascular conditions.
“It's not going to replace triptans for people that are doing well on triptans that have no cardiovascular risk factors," said Susan Hutchinson, MD, a headache specialist at the Orange County Migraine & Headache Center in Irvine, CA, who presented the findings. “The triptans are here to stay, but this is particularly welcome for patients that have contraindications to the triptans because of cardiovascular risk factors."
In the multicenter, open-label safety study, researchers tracked data for about 1,800 participants, 518 of whom had one cardiovascular risk factor, and 217 of whom had two or more. Risk factors included a family history of coronary artery disease, treatment for high blood pressure, being a current smoker, treatment with a statin, or a history of diabetes.
They found that 59.6 percent of patients with no risk factors had at least one adverse event, compared with 61.4 percent of those with one risk factor, and 59.5 percent of those with two or more. Serious adverse events occurred in similarly even amounts—in 2.7 percent of those with no risk factors, 2.5 percent with one risk factor and 2.3 percent of those with two or more. There was also no difference in those with adverse events related to rimegepant, as assessed by investigators—20.4 percent of those with no risk factors, 29.8 percent of those with one, and 16.1 percent of those with two or more.
Only one of the 1,800 patients had an ischemic cardiac disorder system organ class adverse event—a case of angina pectoris—but investigators deemed it not to be rimegepant-related. Dr. Hutchinson said the man had a history of angina before entering the trial.
Although there are no head-to-head trials comparing rimegepant and triptans—and rimegepant was evaluated by regulators under more strict criteria—the two drug classes seem to produce similar percentages of headache relief, Dr. Hutchinson said.
“In this open label trial, they allowed adults with cardiac risk factors and folks over 65 years old —who normally would not be allowed in a clinical trial," particularly one involving triptans, she said. “That makes me very comfortable as a practicing clinician that I could very safely and comfortably give rimegepant to just about anyone in my practice."
Nina Y. Riggins, MD, PhD, FAAN, a headache specialist and associate professor of neurology at the University of California, San Francisco, said it was nice to see that no serious adverse events were considered rimegepant-related.
“The data are promising and make me hopeful that in the future, at least some groups of the patients with addressed cerebrovascular risk factors, will have more choices for treatment of migraine," she said. “Based on the mechanism of action, there is a possibility that 'gepants' will not cause rebound headache," or medication overuse headache. “It is very important point in the discussion of the treatment plan for persons with frequent migraine attacks."
Dr. Hutchinson has received compensation as a consultant for Alder Pharmaceutical and Allergan Pharmaceuticals. Dr. Riggins had no disclosures.
AAN Abstract S5.002: Hutchinson S, Schim J, Lipton R, et al. 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.