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Safety findings from Phase 3 lasmiditan studies for acute treatment of migraine: Results from SAMURAI and SPARTAN
BACKGROUND: We assessed the safety profile of lasmiditan, a selective 5-HT(1F) receptor agonist without vasoconstrictive activity being developed as an acute therapy for migraine. METHODS: SAMURAI and SPARTAN were Phase 3 double-blind studies of patients with migraine, randomized to oral lasmiditan...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
SAGE Publications
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6787764/ https://www.ncbi.nlm.nih.gov/pubmed/31166697 http://dx.doi.org/10.1177/0333102419855080 |
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author | Krege, John H Rizzoli, Paul B Liffick, Emily Doty, Erin G Dowsett, Sherie A Wang, Jianing Buchanan, Andrew S |
author_facet | Krege, John H Rizzoli, Paul B Liffick, Emily Doty, Erin G Dowsett, Sherie A Wang, Jianing Buchanan, Andrew S |
author_sort | Krege, John H |
collection | PubMed |
description | BACKGROUND: We assessed the safety profile of lasmiditan, a selective 5-HT(1F) receptor agonist without vasoconstrictive activity being developed as an acute therapy for migraine. METHODS: SAMURAI and SPARTAN were Phase 3 double-blind studies of patients with migraine, randomized to oral lasmiditan 50 mg (SPARTAN only), 100 mg, 200 mg, or placebo to be taken within 4 hours of onset of migraine pain. Safety data from the studies were integrated. Treatment-emergent adverse events (occurring within 48 hours of first dose) were considered in the analyses. RESULTS: The safety population comprised 1262 patients assigned placebo, and 654, 1265, and 1258 assigned lasmiditan 50 mg, 100 mg, and 200 mg, respectively. There were no deaths; serious adverse events were reported for seven patients (placebo, n = 2 [0.2%]; lasmiditan 50 mg, n = 1 [0.2%]; lasmiditan 100 mg, n = 1 [0.2%]; lasmiditan 200 mg, n = 3 [0.2%]). Patients reporting ≥ 1 treatment-emergent adverse events were: Placebo, n = 174 (13.5%); lasmiditan 50 mg, n = 166 (25.4%); lasmiditan 100 mg, n = 458 (36.2%); and lasmiditan 200 mg, n = 510 (40.6%). Treatment-emergent adverse events were generally mild or moderate in severity. The most common treatment-emergent adverse events with lasmiditan were dizziness, paresthesia, somnolence, fatigue, nausea, muscular weakness and hypoesthesia. There were no ischemic events. CONCLUSIONS: As a centrally-penetrant drug, lasmiditan use was associated with neurologic treatment-emergent adverse events; most were mild or moderate in severity and self-limiting. TRIAL REGISTRATION AT CLINICALTRIALS.GOV: SAMURAI (NCT02439320) and SPARTAN (NCT02605174). |
format | Online Article Text |
id | pubmed-6787764 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | SAGE Publications |
record_format | MEDLINE/PubMed |
spelling | pubmed-67877642019-10-23 Safety findings from Phase 3 lasmiditan studies for acute treatment of migraine: Results from SAMURAI and SPARTAN Krege, John H Rizzoli, Paul B Liffick, Emily Doty, Erin G Dowsett, Sherie A Wang, Jianing Buchanan, Andrew S Cephalalgia Original Articles BACKGROUND: We assessed the safety profile of lasmiditan, a selective 5-HT(1F) receptor agonist without vasoconstrictive activity being developed as an acute therapy for migraine. METHODS: SAMURAI and SPARTAN were Phase 3 double-blind studies of patients with migraine, randomized to oral lasmiditan 50 mg (SPARTAN only), 100 mg, 200 mg, or placebo to be taken within 4 hours of onset of migraine pain. Safety data from the studies were integrated. Treatment-emergent adverse events (occurring within 48 hours of first dose) were considered in the analyses. RESULTS: The safety population comprised 1262 patients assigned placebo, and 654, 1265, and 1258 assigned lasmiditan 50 mg, 100 mg, and 200 mg, respectively. There were no deaths; serious adverse events were reported for seven patients (placebo, n = 2 [0.2%]; lasmiditan 50 mg, n = 1 [0.2%]; lasmiditan 100 mg, n = 1 [0.2%]; lasmiditan 200 mg, n = 3 [0.2%]). Patients reporting ≥ 1 treatment-emergent adverse events were: Placebo, n = 174 (13.5%); lasmiditan 50 mg, n = 166 (25.4%); lasmiditan 100 mg, n = 458 (36.2%); and lasmiditan 200 mg, n = 510 (40.6%). Treatment-emergent adverse events were generally mild or moderate in severity. The most common treatment-emergent adverse events with lasmiditan were dizziness, paresthesia, somnolence, fatigue, nausea, muscular weakness and hypoesthesia. There were no ischemic events. CONCLUSIONS: As a centrally-penetrant drug, lasmiditan use was associated with neurologic treatment-emergent adverse events; most were mild or moderate in severity and self-limiting. TRIAL REGISTRATION AT CLINICALTRIALS.GOV: SAMURAI (NCT02439320) and SPARTAN (NCT02605174). SAGE Publications 2019-06-05 2019-07 /pmc/articles/PMC6787764/ /pubmed/31166697 http://dx.doi.org/10.1177/0333102419855080 Text en © International Headache Society 2019 http://creativecommons.org/licenses/by-nc/4.0/ This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (http://www.creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage). |
spellingShingle | Original Articles Krege, John H Rizzoli, Paul B Liffick, Emily Doty, Erin G Dowsett, Sherie A Wang, Jianing Buchanan, Andrew S Safety findings from Phase 3 lasmiditan studies for acute treatment of migraine: Results from SAMURAI and SPARTAN |
title | Safety findings from Phase 3 lasmiditan studies for acute treatment
of migraine: Results from SAMURAI and SPARTAN |
title_full | Safety findings from Phase 3 lasmiditan studies for acute treatment
of migraine: Results from SAMURAI and SPARTAN |
title_fullStr | Safety findings from Phase 3 lasmiditan studies for acute treatment
of migraine: Results from SAMURAI and SPARTAN |
title_full_unstemmed | Safety findings from Phase 3 lasmiditan studies for acute treatment
of migraine: Results from SAMURAI and SPARTAN |
title_short | Safety findings from Phase 3 lasmiditan studies for acute treatment
of migraine: Results from SAMURAI and SPARTAN |
title_sort | safety findings from phase 3 lasmiditan studies for acute treatment
of migraine: results from samurai and spartan |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6787764/ https://www.ncbi.nlm.nih.gov/pubmed/31166697 http://dx.doi.org/10.1177/0333102419855080 |
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