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Small molecule calcitonin gene-related peptide (CGRP) antagonists (gepants) were approved for the acute treatment of migraine in the U.S. and Europe in 2019 and 2022, respectively; however, no clinical trials were performed in China and South Korea. Due to differences in prescribing patterns and patient characteristics in China and South Korea, a clinical trial was needed to assess the efficacy and safety of rimegepant in these populations.
In this industry-funded, double-blind, randomized, placebo-controlled, phase 3 trial, 1340 adults with at least a 1-year history of moderate-to-severe episodic migraine were randomly assigned to either rimegepant or placebo. Patients were required to have 2 to 8 moderate or severe attacks per month. Patients with chronic migraine were excluded.
Rimegepant was significantly more effective than placebo for both primary endpoints: pain freedom at 2 hours (20% vs. 11%) and freedom from the most bothersome symptom, which could be photophobia, phonophobia, or nausea (50% vs. 36%). Treatment was also well tolerated with no serious adverse events.
Yu S et al. Safety and efficacy of rimegepant orally disintegrating tablet for the acute treatment of migraine in China and South Korea: A phase 3, double-blind, randomised, placebo-controlled trial. Lancet Neurol 2023 Jun; 22:476. (https://doi.org/10.1016/S1474-4422(23)00126-6)
Comment
This study demonstrates similar rates of efficacy and tolerability of rimegepant for acute migraine in patients in China and South Korea as compared with prior clinical trials conducted in the U.S. The findings are important because rimegepant may serve to fill an unmet need of patients with intolerance or contraindications to triptans, particularly since stroke and ischemic heart disease are common causes of mortality in China and South Korea. The study doesn't address the long-term effectiveness of this therapy, which remains to be seen. This study's results suggest that rimegepant should be considered for use in China and South Korea and that other gepants should be investigated in these populations.