Lasmiditan efficacy in the acute treatment of migraine was independent of prior response to triptans: Findings from the CENTURION study

Reuter, Uwe; Krege, John H.; Lombard, Louise; Valderas, Elisa Gomez; Krikke-Workel, Judith; Dell’Agnello, Grazia; Dowsett, Sherie A.; Buse, Dawn C.

doi:10.1177/03331024211048507

Cited by 16 publications

(8 citation statements)

References 34 publications

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“…Rimegepant has also consistently demonstrated favorable safety and tolerability, which may benefit patients whose insufficient response is due to AEs. The efficacy findings from this analysis are comparable to those seen in the individual rimegepant trials and consistent with the results of post-hoc analyses of the effects of prior triptan exposure on the efficacy of ubrogepant, lasimiditan, and triptans (30,32,35,36). This analysis differs from previous work by distinguishing between participants who had a history of insufficient response to 1 triptan and participants who had a history of insufficient response to 2 triptans.…”

Section: Discussionsupporting

confidence: 81%

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

et al. 2023

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Background 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. Methods 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. Results 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 ( p ≤ 0.013), except for freedom from the most bothersome symptom in the triptan-naïve group ( p = 0.06). No differences on co-primary endpoints were found in pairwise comparisons of rimegepant-treated participants. Conclusions 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

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Section: Discussionsupporting

confidence: 81%

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

et al. 2023

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“…Nonetheless, it remains to be seen whether central inhibition of the trigeminovascular system is required for its efficacy. As the mechanism of action is at least partly different from triptans, lasmiditan may be effective in patients with inadequate triptan response (32,33). In a post-hoc subgroup analysis of a phase 3 study of lasmiditan, 43% of included patients were defined as insufficient responders to triptans based on self-reports (overall response to treatment was rated as good, poor, or none).…”

Section: Response To Lasmiditan Rimegepant and Ubrogepant In Triptan ...mentioning

confidence: 99%

Place of next generation acute migraine specific treatments among triptans, non-responders and contraindications to triptans and possible combination therapies

et al. 2023

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Background: For many years triptans have been the cornerstone of acute migraine treatment. Nevertheless, treatment with triptans may not always be initiated due to contraindications (seen in approximately one fifth of patients) or inadequate response (seen in approximately one third of patients). New acute therapies, including 5-hydroxytryptamine (5-HT)1F receptor agonists, also known as ditans (lasmiditan) and small molecule antagonists of the calcitonin gene-related peptide receptor, also known as gepants (rimegepant and ubrogepant), may be an effective alternative. Methods: We searched Pubmed for keywords, summarized the literature and provided a comprehensive review on the place of next generation acute migraine specific treatments among triptans. Results and conclusion: Post-hoc analyses reported no differences in efficacy of gepants/ditans between responders and non-responders to triptans, but research is hampered by lack of consensus on the definition of non-responder. Due to (partially) overlapping mechanisms of action, it remains unknown whether combination therapy with lasmiditan, gepants and triptans will have added value over monotherapy. Preclinical studies and post-hoc analyses cautiously indicate that these new drugs are safe for patients with cardiovascular risk factors. However, long-term studies are needed to prove cardiovascular safety. The risk of developing medication overuse headache may differ between triptans, ditans and gepants, but further studies are needed to confirm this difference. Head-to-head randomized controlled trials of acute therapies and combinations of therapies are needed to determine their place in migraine treatment among established therapies.

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“…These variabilities could be derived from the small number of patients in the 50 mg groups. Previously reported results with a higher sample size demonstrated that efficacy of lasmiditan was independent of history of migraine with aura and prior response to triptans [ 11 , 12 , 31 ]. In summary, although treatment-by-subgroup interactions (by each arm) were observed with respect to the 50 mg dose as a result of the small sample size, our findings suggested that the efficacy of lasmiditan in Japanese patients with migraine is not influenced by migraine disease characteristics.…”

Section: Discussionmentioning

confidence: 99%

Efficacy of Lasmiditan Across Patient and Migraine Characteristics in Japanese Patients with Migraine: A Secondary Analysis of the MONONOFU Trial

et al. 2022

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Introduction This MONONOFU trial subgroup analysis evaluates the efficacy of lasmiditan across patient and migraine characteristics in Japanese patients with migraine. Methods MONONOFU trial was a multicenter, randomized, double-blind, placebo-controlled study. The patients were randomly assigned in a 3:7:6:7 ratio to receive lasmiditan 50 mg, 100 mg, 200 mg, or placebo for a single migraine attack within 4 h of pain onset. Efficacy of lasmiditan vs placebo was evaluated at 2 h post dose for proportion of patients with headache pain freedom. Efficacy was assessed across patient characteristics (age, sex, body weight, cardiovascular risk factors (CVRF), and comorbidity of tension-type headache), migraine disease characteristics (history of migraine with aura, migraine prevention therapy, triptan response, and triptan use or nonuse), and migraine attack characteristics (headache severity, aggressive headache, attack during perimenstrual period, time to dosing, time of dosing, experienced treatment-emergent adverse event (TEAE) of dizziness, and experienced TEAE of somnolence). Logistic regression was used; all subgroup analyses were not analyzed with multiplicity-adjusted statistical tests. Results Treatment-by-subgroup interactions (by each arm) were not significant ( p ≥ 0.05) for pain freedom at 2 h post dose across all patient subgroups and lasmiditan doses, except for CVRF (100 mg and 200 mg), migraine with aura (50 mg), triptan response (50 mg), and time to dosing (200 mg). Treatment-by-subgroup interactions (by overall) were not significant ( p ≥ 0.05) for pain freedom at 2 h post dose across all patient subgroups, except for CVRFs. Higher proportions of patients were pain free at 2 h post dose when treated with lasmiditan (50 mg, 100 mg, and 200 mg) versus placebo, irrespective of most patient characteristics, migraine disease characteristics, and migraine attack characteristics. Conclusion Although few interactions were observed, lasmiditan could be a promising acute treatment option in a wide range of Japanese patients with migraine, as efficacy is not generally influenced by patient and migraine characteristics. Supplementary Information The online version contains supplementary material available at 10.1007/s12325-022-02304-0.

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Lasmiditan efficacy in the acute treatment of migraine was independent of prior response to triptans: Findings from the CENTURION study

Cited by 16 publications

References 34 publications

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

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

Place of next generation acute migraine specific treatments among triptans, non-responders and contraindications to triptans and possible combination therapies

Efficacy of Lasmiditan Across Patient and Migraine Characteristics in Japanese Patients with Migraine: A Secondary Analysis of the MONONOFU Trial

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