Rimegepant shows favourable safety & tolerability in migraine patients with CV risk factors

In migraine patients with cardiovascular (CV) risk factors, including those with moderate to high CV risk, rimegepant for long-term acute treatment of migraine is associated with favourable safety and tolerability, post hoc subgroup analyses of a 52-week multicentre open-label safety study have shown.

The study evaluated the safety and tolerability of rimegepant (75 mg up to once daily pro re nata [PRN] for up to 52 weeks, or every other day as scheduled plus a PRN dose for migraine attacks of any severity on nonscheduled dosing days for 12 weeks) in 1,800 patients with ≥1 year’s history of migraine (mean age, 43.1 years; female, 89.4 percent; mean number of moderate-to-severe migraine attacks, 6.7 per month). Results showed that most on-treatment adverse events (AEs) were mild or moderate, with no signal of hepatotoxicity, potential drug abuse or medication overuse headache. [Cephalalgia 2024;44:1-11]

As treatment options for migraine can be limited in patients with CV risk factors, the investigators conducted post hoc subgroup analyses to evaluate rimegepant’s safety according to the number of CV risk factors (0, 1 or ≥2) and Framingham Risk Score (<10 or ≥10 percent) among the study’s population. [Pain Ther 2024;doi:10.1007/s40122-024-00626-1]

Among the 1,800 study participants, 1,065 (59.1 percent) had 0 CV risk factors, 518 (28.8 percent) had 1 CV risk factor, and 217 (12.1 percent) had ≥2 CV risk factors. The most common CV risk factor was family history of coronary artery disease (23.6 percent), followed by treatment for hypertension (11.7 percent), current smoking (10.4 percent), treatment with a statin (8.3 percent), and history of diabetes (3.0 percent).

Framingham Risk score was <10 percent in 1,673 patients (92.9 percent) and ≥10 percent in 126 patients (7.0 percent).

Mean rimegepant exposure was 7.8, 7.3 and 8.0 tablets per month among patients with 0, 1 and ≥2 CV risk factors, and 7.7 and 7.4 tablets per month for those with Framingham Risk Score <10 and ≥10 percent, respectively.

“Across the subgroups with 0, 1 and ≥2 CV risk factors and Framingham Risk Score <10 and ≥10 percent, consistent proportions of participants reported AEs [59.6, 61.4, 62.2, 59.9 and 67.5 percent, respectively] and serious AEs [2.7, 2.5, 2.3, 2.6 and 2.4 percent, respectively],” the investigators noted.

“The most common AE was upper respiratory tract infection, occurring in <10 percent of participants across all subgroups. The majority of AEs were mild or moderate in intensity,” they added.

The incidence of AEs leading to study drug discontinuation was low across subgroups, at 1.9, 3.1 and 5.5 percent among participants with 0, 1 and ≥2 CV risk factors, and 2.5 and 4.8 percent among those with Framingham Risk Score <10 and ≥10 percent, respectively.

“Rimegepant, administered up to once daily and for up to 1 year, showed favourable safety and tolerability in adults with migraine with CV risk factors, including those with a moderate or high 10-year risk of developing a CV condition,” the investigators concluded.