Effectiveness and safety of lasmiditan and rimegepant in the acute migraine treatment: an indirect real-world comparison
Year: 2026
Type: article
Abstract: AIM: Rimegepant and lasmiditan are effective acute migraine treatments, but real-world head-to-head comparative data are lacking. We aimed to compare their effectiveness and tolerability in clinical practice. METHODS: This post-hoc study indirectly compared two prospective, multicenter, real-world studies (GAINER and DART). Participants treated up to four migraine attacks with rimegepant 75 mg orally disintegrating tablets or lasmiditan 50 or 100 mg. Data were collected using an electronic diary every 30 min up to 2 hours after dosing. The co-primary outcomes were 2-hour pain freedom and incidence of adverse events (AEs) comparing rimegepant with lasmiditan in the first treated attack. RESULTS: The overall cohort included 249 individuals, 58 treated with lasmiditan and 191 with rimegepant (81.1% females, age 45.8 [43.4-48.1] years, 9.6 [8.3 - 10.8] monthly migraine days, 26.9% with chronic migraine). Pain freedom 2-hour post dose in the first treated attack was comparable between rimegepant and lasmiditan (43.5%, n = 83 vs. 32.8%, n = 19, p = 0.171). The relative risk (RR) of achieving 2-hour pain freedom with lasmiditan versus rimegepant was 0.75 [0.50 - 1.28] (p = 0.169). The percentage of participants who reported at least one AE in the first treated attack was higher with lasmiditan than with rimegepant (53.4% vs. 11.5%; RR 4.64 [2.93-7.35], p < 0.001). CONCLUSION: Lasmiditan and rimegepant demonstrated comparable effectiveness, although more participants reported AEs after lasmiditan intake. Nonetheless, this indirect comparison warrants further confirmation. TRIAL REGISTRATION: GAINER registration at www. CLINICALTRIAL: gov : NCT05903027; DART registration at www. CLINICALTRIAL: gov : NCT05903040.
Source: Neurological Sciences
Authors: Gloria Vaghi, Luigi Francesco Iannone, Gabriele Sebastianelli, Elisa Maria Piella, Michele Corrado, Marina Romozzi, Federico De Santis, Raffaele Ornello, Francesca Pistoia, Francesco De Cesaris, Andrea Burgalassi, Gianluca Coppola, Marcello Silvestro, Innocenzo Rainero, Giorgio Dalla Volta, Danilo Antonio Montisano, Simona Guerzoni, Maria Pia Prudenzano, Davide Mascarella, Gianluca Avino, Edoardo Mampreso, Mariarosaria Valente, Stefania Battistini, Antonio Granato, Maria Albanese, Michele Trimboli, Alberto Doretti, Roberto De Icco, the Italian Headache Registry (RICe) Study Group, Cristina Tassorelli, Martina Giraudo, Francesco Casillo, Flavia Lo Castro, Rossana Allamprese, Alessia Agostinelli, Gennaro Saporito, Simona Sacco, Antonio Munafò, Alberto Chiarugi, Giovanna Carlucci, Antonio Russo, Marco Bolchini, Matteo Cortinovis, Licia Grazzi, Martino Gentile, Adriana Fallacara, Sabina Cevoli, Enrico Grassi, Catello Vollono, Sara Pez, Luca Bartole, Antonio Meo, Vittoria Carla D’Agostino, Nicola Mercuri Biagio, Eleonora Colombo, Alessandro Cocuzza
Institutions: University of Pavia, Fondazione Istituto Neurologico Nazionale Casimiro Mondino, Azienda Ospedaliero-Universitaria di Modena, Sapienza University of Rome, University of Turin, Università Cattolica del Sacro Cuore, Agostino Gemelli University Polyclinic, University of L'Aquila, University of Florence, University of Campania "Luigi Vanvitelli", Fondazione IRCCS Istituto Neurologico Carlo Besta, University of Bari Aldo Moro, Istituto delle Scienze Neurologiche di Bologna, Ospedale di Prato Santo Stefano, Azienda Usl Toscana Centro, University of Udine, Azienda sanitaria universitaria Friuli Centrale, University of Siena, University of Trieste, University of Rome Tor Vergata, Azienda Ospedaliero-Universitaria "Renato Dulbecco", IRCCS Istituto Auxologico Italiano
Language: English
Subfield: Clinical Neurology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,090
Funder: Ministero della Salute
Award: G5830467628
OpenAlex ID: W7225248312