Neurology and therapy · 2026
Efficacy and Safety of Rimegepant for the Acute Treatment of Migraine in Adults of Hispanic or Latino Ethnicity: Post Hoc Analysis of Three Randomized, Placebo-Controlled Trials.
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Vieira Julio R, Fajardo Meghan, Abbott Chandra, Li Jessica, Sellix Michael T
Аннотация
INTRODUCTION: This post hoc exploratory analysis evaluated the efficacy and safety of rimegepant 75 mg for the acute treatment of migraine in patients that are Hispanic or Latino (HL), non-HL White (nHLW), and non-HL Black/African American (nHLB/AA).
METHODS: Data were pooled from three multicenter, double-blind, randomized, placebo-controlled, phase 3 trials of rimegepant. Each study comprised a 28-day screening period, treatment phase (up to 45 days), and end of treatment visit within 7 days. Patients treated a single migraine attack of moderate to severe pain intensity during the treatment phase. Co-primary endpoints in the phase 3 trials were pain freedom and freedom from most bothersome symptom (MBS) both at 2 h post dose.
RESULTS: A total of 546 patients that are HL and 2872 patients that are non-HL (nHLW, n = 2215; nHLB/AA, n = 657) were enrolled. Patients that are HL exhibited a trend, but did not achieve statistical significance, with nominal p < 0.05 for pain freedom (PF) (19.9% rimegepant vs. 13.6% placebo, p = 0.051) or freedom from MBS (31.8% rimegepant vs. 31.8% placebo, p = 0.999), both at 2 h post dose. Exploratory analyses showed that patients that are nHLW and patients that are nHLB/AA achieved responses at 0.75-1.5 h and 1-2 h post dose, respectively, for pain relief, PF, and freedom from MBS, and these were maintained through 48 h. Responses for each were delayed in patients that are HL, starting at 3-4 h post dose and maintained through 48 h. Safety outcomes were similar across subgroups.
CONCLUSION: Rimegepant was effective and safe for the acute treatment of migraine. Co-primary endpoints at 2 h post dose were not met in patients that are HL; exploratory analyses suggest that patients that are HL may experience a 1-2 h delayed response to rimegepant, with a greater proportion of patients that are HL having responded at 24-48 h post treatment.
TRIAL REGISTRATION: ClinicalTrials.gov identifiers: NCT03235479; NCT03237845; NCT03461757.
METHODS: Data were pooled from three multicenter, double-blind, randomized, placebo-controlled, phase 3 trials of rimegepant. Each study comprised a 28-day screening period, treatment phase (up to 45 days), and end of treatment visit within 7 days. Patients treated a single migraine attack of moderate to severe pain intensity during the treatment phase. Co-primary endpoints in the phase 3 trials were pain freedom and freedom from most bothersome symptom (MBS) both at 2 h post dose.
RESULTS: A total of 546 patients that are HL and 2872 patients that are non-HL (nHLW, n = 2215; nHLB/AA, n = 657) were enrolled. Patients that are HL exhibited a trend, but did not achieve statistical significance, with nominal p < 0.05 for pain freedom (PF) (19.9% rimegepant vs. 13.6% placebo, p = 0.051) or freedom from MBS (31.8% rimegepant vs. 31.8% placebo, p = 0.999), both at 2 h post dose. Exploratory analyses showed that patients that are nHLW and patients that are nHLB/AA achieved responses at 0.75-1.5 h and 1-2 h post dose, respectively, for pain relief, PF, and freedom from MBS, and these were maintained through 48 h. Responses for each were delayed in patients that are HL, starting at 3-4 h post dose and maintained through 48 h. Safety outcomes were similar across subgroups.
CONCLUSION: Rimegepant was effective and safe for the acute treatment of migraine. Co-primary endpoints at 2 h post dose were not met in patients that are HL; exploratory analyses suggest that patients that are HL may experience a 1-2 h delayed response to rimegepant, with a greater proportion of patients that are HL having responded at 24-48 h post treatment.
TRIAL REGISTRATION: ClinicalTrials.gov identifiers: NCT03235479; NCT03237845; NCT03461757.