Treatment of Migraine Using Rimegepant Reduces Use of Analgesics and Antiemetics

 

April 17, 2021—Using rimegepant as needed or at least every other day reduced the need for medications that relieve the pain and nausea/vomiting associated with migraines among patients with a history of moderate-to-severe migraines. The findings were presented at the virtual meeting of the American Academy of Neurology, which took place from April 17 to 22.

“Nonsteroidal anti-inflammatory drugs, acetaminophen, caffeinated analgesics, and antiemetics are widely used therapies for the acute treatment of migraine,” wrote the authors in their study poster. “The clinical benefits these nonspecific drugs provide can be inadequate for severe migraine pain and associated symptoms. They also have safety issues and the potential to cause medication overuse headache.” The study was led by David Kudrow, MD, from the California Medical Clinic for Headache in Santa Monica.

The idea behind the present study was that reducing the use of such nonspecific medications, with administration of rimegepant, could cut down overall medication use and thus lessen the risks of adverse events and medication overuse.

The multicenter, open-label, long-term safety study included 1800 patients who orally self-administered rimegepant 75 mg as need, up to once daily, for 52 weeks (n = 1514) or every other day for up to 12 weeks (n = 286). Patients were 18 years of age or older with at least a 1-year history of migraine with or without aura. They also experienced 2 to 14 moderate/severe monthly migraine attacks in the 3 months prior to the screening visit. Patients using migraine preventive medication had to have been on a stable dose for at least 3 months. All participants were permitted to use standard-of-care analgesics and antiemetics. Triptan use was permitted during the 30-day observation period preceding the 52-week rimegepant treatment period.

The as-needed group comprised 1033 patients with a history of 2 to 8 moderate/severe migraines each month and 481 with a history of 9 to 14 moderate/severe migraines per month. The every-other-day group was established to provide patients with a more flexible option of pain relief. These patients could still take rimegepant in the intervening day, if needed.

Overall, most participants (89.4%) were female, with a mean age of 43 years. The groups were comparable at baseline in terms of mean age, sex, race (about 82% white), and mean duration of untreated migraines (about 34 hours). The primary migraine type was without aura in about 65% of patients taking rimegepant as needed and about 75% in those taking it every other day. Those taking rimegepant every other day also tended to have a lower body weight and body mass index.

In total, 112,014 dose s of rimegepant were administered across the 1800 patients. The median number of doses taken over 4 weeks was 4.9 in the as-needed group with 2 to 8 migraines per month, 7.8 in the as-needed group with 4 to 15 migraines per month, and 14.2 in the every-other-day group.

During the observation period prior to starting rimegepant, analgesics or antiemetics were used by 80% of patients. Overall, the most commonly used analgesics were ibuprofen (41.1%), fixed combination acetaminophen/aspirin/caffeine (36.4%), acetaminophen (17.2%), and naproxen (13.3%). Antiemetics were used by 5.9% of the subjects and most commonly included ondansetron, promethazine, dimenhydrinate, meclizine, and prochlorperazine.

Freedom from using select analgesics and antiemetics increased over the first 12 weeks of rimegepant treatment. Overall, the percentage of patients who eliminated their use of select analgesics or antiemetics increased from 19.9% at baseline to 44.6% during weeks 1 to 4 of rimegepant treatment, 58.3% during weeks 5 to 8, and to 61.6% during weeks 9 to 12. During weeks 49 to 52, 67.6% of patients reported no use of select analgesics and antiemetics.

In patients taking rimegepant as needed, a 100% reduction in analgesic and antiemetic use by those with a history of 2 to 8 migraines per month was achieved in 39.0% after 1 to 4 weeks, 54.0% after 5 to 8 weeks, and 58.5% after 9 to 12 weeks. The respective values in patients with a history of 9 to 14 migraines monthly was 33.4%, 46.9%, and 48.8%. In the every-other-day group, the respective values were 40.4%, 55.9%, and 61.3%. The combined results for all three groups were 38.9%, 52.6%, and 56.5%, respectively.

In the as-needed treatment group, a 100% reduction in analgesic and antiemetic use continued to increase during weeks 49 to 52. It was achieved in 62.7% with a history of 2 to 8 migraines per month and in 57.8% with a history of 9 to 14 migraines per month. Overall, a 100% reduction was found in 61.3% of patients.

“The majority of participants eliminated the use of common analgesic and antiemetic medications during long-term treatment with rimegepant. Reductions in [their] use were noted within the first month of rimegepant treatment and increased over time,” concluded Dr. Kudrow and colleagues in their poster.

This study was conducted in collaboration with Biohaven Pharmaceuticals.