Oral Rimegepant in Adults With Migraine and Cardiovascular Risk Factors
In this podcast, Susan Hutchinson, MD, discusses the implications for her team's research presented in the session "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" at the American Academy of Neurology's 2021 Virtual Annual Meeting.
- 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." Presented at: American Academy of Neurology 2021 Virtual Annual Meeting; April 17-21, 2021; Virtual. https://index.mirasmart.com/AAN2021/PDFfiles/AAN2021-001995.html
Susan Hutchinson, MD, is the director and founder of the Orange County Migraine and Headache Center in Irvine, California.
Jessica Bard: Hello, everyone. Welcome to another installment of "Podcast 360," your go‑to resource for medical news and clinical updates. I'm your moderator Jessica Bard with "Consultant360 Specialty Network."
Rimegepant is FDA‑approved for the acute treatment of migraine, an important step for patients who have contraindications to triptans due to their cardiovascular risk factors. Dr Susan Hutchinson is here to speak with us about that today. Dr Hutchinson is the director and the founder of the Orange County Migraine and Headache Center in Irvine, California.
Thank you for joining us today, Dr Hutchinson. You're presenting your research, "Oral Rimegepant 75 mg is Safe and Well Tolerated in Adults with Migraine and Cardiovascular Risk Factors," results from a multicenter long‑term, open‑label safety study at AAN 2021. Can you please give us an overview of your research and its findings?
Dr Susan Hutchinson: Yes, this is actually very exciting. We know that the triptans, which have been around since 1992, they've been a very good category for the acute treatment of migraine in adults in the United States. However, there's some limitations because they cause vasoconstriction, which is the narrowing of the blood vessels. That is not good for over 3.5 million adults in the United States.
We really need something to treat migraine attacks in adults that have cardiovascular risk factors. I think some of the strengths of the study are that it was a 52‑week open‑label study. That's very important because sometimes you might find new safety concerns in a 52‑week trial that weren't identified in a shorter clinical trial.
Another strength is that there was 1,800 participants in this clinical trial. That's a lot of subjects. What we did is we took those 1,800 adults, and we broke it down by cardiovascular risk factors. Some in the study had no cardiac risk factors. Some had one, others had two or more.
We also sub‑analyzed by Framingham risk score. Some had less than a 10 percent. Some had a higher Framingham score. The nice thing too, is that patients with cardiovascular risk factors were allowed to be in this clinical trial, that's important.
Jessica: Triptans are contraindicated or must be used with caution in about 3.5 million people with migraine due to cardiovascular safety concerns. Why was it important to study oral rimegepant in this population for this indication?
Dr Hutchinson: That is a great question. The reason it was so important to look at rimegepant in this patient population is rimegepant does not cause vasoconstriction. It has a different mechanism of action.
The triptans are 5‑HT1B/1D receptor agonist. The 5‑HT1B is what's responsible for the vasoconstriction. On the other hand, rimegepant, which is what we call a gepant, it's an oral CGRP receptor antagonist and there is no vasoconstriction.
Jessica: Overall, your study found that rimegepant dosed up to once daily, for up to one year showed favorable safety and tolerability in adults with migraine with CV risk factors, including adults with moderate to high CV risk. How will this result impact clinical practice in how migraine is managed in adults with CV risk factors?
Dr Hutchinson: The take‑home of this study, [inaudible 3:27] is that we allow patients with cardiac risk factors and high Framingham score to begin the clinical trial. When we followed it out over a year, there was no difference in side effect profile or tolerability, whether someone had zero or two or more cardiac risk factors.
The take‑home, I feel, is that we now have a category, the gepants ‑‑ and, in particular, this is rimegepant 75 milligrams which can be dosed once daily. We now have a treatment that we can offer our patients who have contraindications to the triptans, or what I like to call relative contraindications due to their [inaudible 4:07] risk factors. This is so important because we can't cure migraine.
I like to say, as I'm getting older, my patients are getting older. As we get older, we tend to start developing cardiac risk factors such as hypertension, hyperlipidemia, diabetes. This has huge clinical implications.
Jessica: Absolutely. What's next, Dr Hutchinson, in research on this topic?
Dr Hutchinson: What's next is, as we start using rimegepant in this patient population, we're going to continue to need to do further ongoing safety trials. I can see extending this out to three, four, five years. We need to make sure that this category continues to be safe and well‑tolerated. We still need ongoing safety surveillance.
I also think it'll be interesting over time to see, "Could we take a drug like rimegepant and, at some point, use it more as a preventative rather than acute?" That's actually been looked at and there'll be some results talked about in that regards at AAN. A lot of excitement in looking at rimegepant not only for acute, but potentially prevention of migraine attacks.
Jessica: Is there anything else that you'd like to add today?
Dr Hutchinson: I'd just like to add to that in this clinical trial, there was no upper age limit. We did have adults who were over 65. That's important because if you look at a lot of the earlier clinical trials with triptans, those patients were often excluded, as were patients with cardiac risk factors. That's the take‑home point.
The bottom line is, I think that rimegepant ‑‑ from the data we know, the data we presented ‑‑ can safely and effectively be used in adults with cardiac risk factors for whom the triptans are contraindicated.
Jessica: Thank you so much for your time today, Dr Hutchinson.
Dr Hutchinson: Thank you.