Systematic review and meta-analysis on the efficacy and safety of rimegepant for migraine

Background Migraine is a prevalent neurological condition, affecting approximately 14% of the population, and is a leading cause of disability. Conventional treatments may have limited efficacy and tolerability limitations in clinical practice. Rimegepant is approved for the dual indications of managing acute migraine episodes and preventing migraine attacks. Therefore, we sought to evaluate the efficacy and safety of rimegepant in migraine treatment. Method A systematic search of public databases from their inception until February 2025 was conducted to identify randomized controlled trials for evaluating the efficacy of rimegepant in migraine treatment. The overall estimate was derived using the 95% confidence interval (CI) and risk ratio (RR) in a random-effects model. GRADEprofiler was employed to assess the quality of evidence. The Cochrane Collaboration was utilized to evaluate the risk of bias. Results Our investigation reviewed 5 studies, which included 2,715 individuals treated with rimegepant and 2,850 control participants. Patients treated with rimegepant had statistically significant pain relief (RR = 1.34; 95% CI 1.27–1.41; p < 0.05; I 2 = 0%) and freedom from Most Bothersome Symptom (MBS) 2 h after treatment (RR = 1.38; 95% CI 1.28–1.49; p < 0.05; I 2 = 0%). However, the initial therapeutic success with rimegepant does not correlate with a sustained lack of pain relapse from 2 h to 48 h (RR = 1.16; 95% CI 0.99–1.37; p > 0.05; I 2 = 0%). There was no statistically significant difference in adverse events observed between the treatment group and the control group (RR = 1.12; 95% CI 0.97–1.28; p > 0.05; I 2 = 0%). Conclusion Our findings suggest that rimegepant may be effective and generally well tolerated for acute migraine treatment. However, the drug did not demonstrate statistical significance for preventing pain relapse within 2–48 h following administration. Given the limitations in the quality and quantity of the included trials, the findings should be confirmed by multicenter, large-sample, randomized controlled trials. Systematic review registration https://www.crd.york.ac.uk/PROSPERO/view/CRD420251180156 , identifier: CRD420251180156.