Efficacy and safety of rimegepant for acute and preventive treatment of migraine: a systematic review and meta-analysis of randomized controlled trials

Abstract

BACKGROUND: Migraine is a disabling neurological disorder with limited tolerability and cardiovascular limitations associated with traditional acute therapies such as triptans. Rimegepant, an oral calcitonin gene-related peptide (CGRP) receptor antagonist, has emerged as a promising treatment option. This meta-analysis evaluated the efficacy and safety of a single 75 mg oral dose of rimegepant for acute preventive treatment of migraine. METHODS: A systematic search of PubMed, Scopus, and Web of Science was conducted from inception to October 2025. Only randomized controlled trials (RCTs) evaluating oral rimegepant 75 mg for acute migraine in adults were included. Primary outcomes included pain freedom and pain relief at 2, 24, and 48 h. Secondary outcomes included freedom from associated migraine symptoms, return to normal function, rescue medication use, and adverse events. A random-effects model was applied for pooled analysis. RESULTS: Nine RCTs involving 7,198 participants were included. Participants received a single 75 mg oral dose of rimegepant per migraine attack. Rimegepant demonstrated significantly greater 2-hour pain freedom compared with placebo (RR = 1.77; 95% CI: 1.5-2.1). Two-hour pain relief was similarly improved (RR = 1.35; 95% CI: 1.28-1.42). Safety outcomes were comparable to placebo, with no significant differences in total adverse events (RR = 1.10) or serious adverse events. CONCLUSION: A single 75 mg oral dose of rimegepant is an effective and well-tolerated therapeutic option for both acute and preventive migraine treatment, offering meaningful clinical improvement and a favorable safety profile. Its non-vasoconstrictive mechanism provides a valuable alternative for patients unable to use triptans or those who respond inadequately to existing therapies.