Efficacy of rimegepant for the acute treatment of migraine based on triptan treatment experience: Pooled results from three phase 3 randomized clinical trials

• Published in: Cephalalgia Vol. 43; no. 2; p. 3331024221141686
• Main Authors: Lipton, Richard B, Blumenfeld, Andrew, Jensen, Christopher M, Croop, Robert, Thiry, Alexandra, L'Italien, Gilbert, Morris, Beth A, Coric, Vladimir, Goadsby, Peter J
• Format: Journal Article
• Language: English
• Published: England 01-02-2023
• Subjects: Adult; Clinical Trials, Phase III as Topic; Humans; Migraine Disorders - drug therapy; Piperidines - therapeutic use; Randomized Controlled Trials as Topic; Serotonin 5-HT1 Receptor Agonists - therapeutic use; Tryptamines - therapeutic use; acute; triptan; Migraine; rimegepant; efficacy
• ISSN: 1468-2982
• DOI: 10.1177/03331024221141686

This post-hoc analysis from three phase 3 treatment trials of rimegepant 75 mg - an oral small molecule calcitonin gene-related peptide receptor antagonist for acute and preventive treatment of migraine - assessed efficacy in adults with migraine based on triptan treatment experience.
Participants were assigned to one of four groups based on triptan treatment experience: insufficient response (e.g. lack of efficacy and/or poor tolerability) to 1 triptan, insufficient response to ≥2 triptans, current triptan users, and triptan-naïve participants. The co-primary efficacy endpoints were pain freedom and most bothersome symptom freedom at two hours postdose.
In the three trials (N = 3507; rimegepant n = 1749, placebo n = 1758), 1235 (35.2%) participants had a history of insufficient response to 1 triptan (n = 910 [25.9%]) or ≥2 triptans (n = 325 [9.3%]), and 2272 (64.8%) had no history of insufficient response to triptans (current use = 595 [17.0%], naïve = 1677 [47.8%]). Rimegepant was effective on the co-primary endpoints in all subgroups (
 ≤ 0.013), except for freedom from the most bothersome symptom in the triptan-naïve group (
 = 0.06). No differences on co-primary endpoints were found in pairwise comparisons of rimegepant-treated participants.
Rimegepant was effective for the acute treatment of migraine in adults with a history of insufficient response to 1 or ≥2 triptans and in current triptan users. Efficacy on co-primary endpoints did not differ based on the number of insufficient triptan responses.Trial registration: Clinicaltrials.gov: NCT03235479, NCT03237845, NCT03461757.