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Original Research

Safety profile of lasmiditan: a retrospective post-marketing pharmacovigilance study based on the real-world data of FAERS database

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Received 23 Feb 2024, Accepted 03 May 2024, Published online: 10 Jul 2024

References

  • Peters GL. Migraine overview and summary of current and emerging treatment options. Am J Manag Care. 2019;25(2 Suppl):S23–S34.
  • Silberstein SD. Migraine. Lancet. 2004;363(9406):381–391. doi: 10.1016/S0140-6736(04)15440-8
  • Berger AA, Winnick A, Popovsky D, et al. Lasmiditan for the treatment of migraines with or without aura in adults. Psychopharmacol Bull. 2020;50(4 Suppl 1):163–188. doi: 10.1080/17425255.2019.1578749
  • Montagna P. The physiopathology of migraine: the contribution of genetics. Neurol Sci. 2004;25(Suppl 3):S93–S96. doi: 10.1007/s10072-004-0261-0
  • Villalon CM, VanDenbrink AM. The role of 5-hydroxytryptamine in the pathophysiology of migraine and its relevance to the design of novel treatments. Mini-Rev Med Chem. 2017;17(11):928–938. doi: 10.2174/1389557516666160728121050
  • Tepper SJ. Acute treatment of migraine. Neurol Clin. 2019;37(4):727–742. doi: 10.1016/j.ncl.2019.07.006
  • Zobdeh F, Ben KA, Attwood MM, et al. Pharmacological treatment of migraine: drug classes, mechanisms of action, clinical trials and new treatments. Brit J Pharmacol. 2021;178(23):4588–4607. doi: 10.1111/bph.15657
  • Anderson CC, VanderPluym JH. Profile of lasmiditan in the acute treatment of migraine in adults: design, development, and place in therapy. Drug Des Devel Ther. 2023;17:1979–1993. doi: 10.2147/DDDT.S380440
  • Hirata K, Matsumori Y, Tanji Y, et al. Safety profile of lasmiditan in patients with migraine in an Asian population. Expert Opin Drug Saf. 2023;22(1):91–101. doi: 10.1080/14740338.2022.2087630
  • Merino D, Gerard AO, Van Obberghen EK, et al. The neuropsychiatric safety profile of lasmiditan: a comparative disproportionality analysis with triptans. Neurotherapeutics. 2023;20(5):1305–1315. doi: 10.1007/s13311-023-01404-1
  • Curto M, Cipolla F, Cisale GY, et al. Profiling lasmiditan as a treatment option for migraine. Expert Opin Pharmaco. 2020;21(2):147–153. doi: 10.1080/14656566.2019.1694004
  • Labastida-Ramirez A, Rubio-Beltran E, Haanes KA, et al. Lasmiditan inhibits calcitonin gene-related peptide release in the rodent trigeminovascular system. Pain. 2020;161(5):1092–1099. doi: 10.1097/j.pain.0000000000001801
  • Amrutkar DV, Ploug KB, Hay-Schmidt A, et al. mRNA expression of 5-hydroxytryptamine 1B, 1D, and 1F receptors and their role in controlling the release of calcitonin gene-related peptide in the rat trigeminovascular system. Pain. 2012;153(4):830–838. doi: 10.1016/j.pain.2012.01.005
  • Gonzalez-Hernandez A, Manrique-Maldonado G, Lozano-Cuenca J, et al. The 5-HT(1) receptors inhibiting the rat vasodepressor sensory CGRPergic outflow: further involvement of 5-HT(1F), but not 5-HT(1A) or 5-HT(1D), subtypes. Eur J Pharmacol. 2011;659(2–3):233–243. doi: 10.1016/j.ejphar.2011.03.035
  • Ma QP. Co-localization of 5-HT(1B/1D/1F) receptors and glutamate in trigeminal ganglia in rats. Neuroreport. 2001;12(8):1589–1591. doi: 10.1097/00001756-200106130-00015
  • Lamb YN. Lasmiditan: first approval. Drugs. 2019;79(18):1989–1996. doi: 10.1007/s40265-019-01225-7
  • Hashimoto Y, Komori M, Tanji Y, et al. Lasmiditan for single migraine attack in Japanese patients with cardiovascular risk factors: subgroup analysis of a phase 2 randomized placebo-controlled trial. Expert Opin Drug Saf. 2022;21(12):1495–1503. doi: 10.1080/14740338.2022.2078302
  • Moreno-Ajona D, Chan C, Villar-Martinez MD, et al. Targeting CGRP and 5-HT(1F) receptors for the acute therapy of migraine: a literature review. Headache. 2019;59(Suppl 2):3–19. doi: 10.1111/head.13582
  • MacGregor EA, Komori M, Krege JH, et al. Efficacy of lasmiditan for the acute treatment of perimenstrual migraine. Cephalalgia. 2022;42(14):1467–1475. doi: 10.1177/03331024221118929
  • Puledda F, Younis S, Huessler EM, et al. Efficacy, safety and indirect comparisons of lasmiditan, rimegepant, and ubrogepant for the acute treatment of migraine: a systematic review and network meta-analysis of the literature. Cephalalgia. 2023;43(3):2079770821. doi: 10.1177/03331024231151419
  • Johnston K, Popoff E, Deighton A, et al. Comparative efficacy and safety of rimegepant, ubrogepant, and lasmiditan for acute treatment of migraine: a network meta-analysis. Expert Rev Pharm Out. 2022;22(1):155–166. doi: 10.1080/14737167.2021.1945444
  • Sadamoto Y. A case of reversible posterior leukoencephalopathy syndrome (PRES) with a history of migraine and onset with initial visual aura and migraine-like headache, with a significant response to lasmiditan: a case report. Cureus J Med Sci. 2023;15(11):e49311. doi: 10.7759/cureus.49311
  • Krege JH, Lipton RB, Baygani SK, et al. Lasmiditan for patients with migraine and contraindications to triptans: a post hoc analysis. Pain Ther. 2022;11(2):701–712. doi: 10.1007/s40122-022-00388-8
  • Ashina M, Roos C, Li LQ, et al. Long-term treatment with lasmiditan in patients with migraine: results from the open-label extension of the CENTURION randomized trial. Cephalalgia. 2023;43(4):2079760495. doi: 10.1177/03331024231161745
  • Zhou J, Luo G, Xu Y, et al. Safety findings in lasmiditan as a novel acute treatment of migraine in Chinese patients: a post hoc analysis of the randomized controlled phase 3 CENTURION trial. Adv Ther. 2022;39(11):5229–5243. doi: 10.1007/s12325-022-02291-2
  • Ahsan M, Mallick AK. Lasmiditan abortive therapy for episodic migraine in phase II/III randomized clinical trials: a meta-analysis. Indian J Pharmacol. 2022;54(6):397–406. doi: 10.4103/ijp.ijp_901_21
  • Chen Z, Li M, Li S, et al. A pharmacovigilance analysis of FDA adverse event reporting system events for romosozumab. Expert Opin Drug Saf. 2023;22(4):339–342. doi: 10.1080/14740338.2023.2130891
  • Tang L, Ding C, Li H, et al. A pharmacovigilance study of adverse event profiles and hemorrhagic safety of bevacizumab based on the FAERS database. Expert Opin Drug Saf. 2023;23(2):213–220. doi: 10.1080/14740338.2023.2248876
  • Wu XP, Lu XK, Wang ZT, et al. Post-marketing safety concerns with upadacitinib: a disproportionality analysis of the FDA adverse event reporting system. Expert Opin Drug Saf. 2023:1–11. doi: 10.1080/14740338.2023.2296966
  • Jiang C, Qian J, Jiang X, et al. Is pitolisant safe for clinical use? A retrospective pharmacovigilance study focus on the post-marketing safety. Pharmacol Res Perspe. 2024;12(1):e1161. doi: 10.1002/prp2.1161
  • Yin Y, Shu Y, Zhu J, et al. A real-world pharmacovigilance study of FDA adverse event reporting system (FAERS) events for osimertinib. Sci Rep-UK. 2022;12(1):19555. doi: 10.1038/s41598-022-23834-1
  • Shu Y, Ding Y, Liu Y, et al. Post-marketing safety concerns with secukinumab: a disproportionality analysis of the FDA adverse event reporting system. Front Pharmacol. 2022;13:862508. doi: 10.3389/fphar.2022.862508
  • Altebainawi AF, Alfaraj LA, Alharbi AA, et al. Association between proton pump inhibitors and rhabdomyolysis risk: a post-marketing surveillance using FDA adverse event reporting system (FAERS) database. Ther Adv Drug Saf. 2023;14:1581606299. doi: 10.1177/20420986231154075
  • Song Y, Xu YL, Lin Y, et al. Fractures due to aromatase inhibitor therapy for breast cancer: a real-world analysis of FAERS data in the past 15 years. Oncol Res Treat. 2020;43(3):96–102. doi: 10.1159/000505376
  • Guo M, Shu Y, Chen G, et al. A real-world pharmacovigilance study of FDA adverse event reporting system (FAERS) events for niraparib. Sci Rep-UK. 2022;12(1):20601. doi: 10.1038/s41598-022-23726-4
  • Liu Y, Dong C, He X, et al. Post-marketing safety of vemurafenib: a real-world pharmacovigilance study of the FDA adverse event reporting system. J Pharm Pharm Sci. 2022;25:377–390. doi: 10.18433/jpps33020
  • Charleston LT, Savage-Edwards B, Bragg SM, et al. Migraine history and response to lasmiditan across racial and ethnic groups. Curr Med Res Opin. 2022;38(5):721–730. doi: 10.1080/03007995.2022.2057152
  • U.S. Food and Drug Administration. EYVOW(lasmiditan) tablets, for oral use[EB/OL]. [cited 2019 Oct 11]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211280s000lbl.pdf
  • Farkkila M, Diener HC, Geraud G, et al. Efficacy and tolerability of lasmiditan, an oral 5-HT(1F) receptor agonist, for the acute treatment of migraine: a phase 2 randomised, placebo-controlled, parallel-group, dose-ranging study. Lancet Neurol. 2012;11(5):405–413. doi: 10.1016/S1474-4422(12)70047-9
  • Zhong C, Zhang X, Qin G, et al. Comparison of lasmiditan 200 mg versus 100 mg for migraine patients: a meta-analysis of randomized controlled studies. Clin Neuropharmacol. 2023;47(1):1–6. doi: 10.1097/WNF.0000000000000567
  • Brandes JL, Klise S, Krege JH, et al. Interim results of a prospective, randomized, open-label, Phase 3 study of the long-term safety and efficacy of lasmiditan for acute treatment of migraine (the GLADIATOR study). Cephalalgia. 2019;39(11):1343–1357. doi: 10.1177/0333102419864132
  • Mecklenburg J, Raffaelli B, Neeb L, et al. The potential of lasmiditan in migraine. Ther Adv Neurol Diso. 2020;13:1279189415. doi: 10.1177/1756286420967847
  • Lamb YN. Galcanezumab: First global approval. Drugs. 2018;78(16):1769–1775. doi: 10.1007/s40265-018-1002-7
  • Talai A, Heilbrunn B. Ondansetron for acute migraine in the pediatric emergency department. Pediatr Neurol. 2020;103:52–56. doi: 10.1016/j.pediatrneurol.2019.06.011
  • Jackson JL, Shimeall W, Sessums L, et al. Tricyclic antidepressants and headaches: systematic review and meta-analysis. Brit Med J. 2010;341(oct20 1):c5222. doi: 10.1136/bmj.c5222
  • Kitamura S, Imai N, Tanji Y, et al. Lasmiditan in Japanese patients with common migraine comorbidities or concomitant medications: a post hoc safety and efficacy analysis from the MONONOFU study. J Pain Res. 2023;16:1725–1738. doi: 10.2147/JPR.S399567
  • Blumenfeld A, Tepper SJ, Khanna R, et al. Serotonin syndrome in the acute treatment landscape of migraine: the lasmiditan experience. Front Neurol. 2023;14:1291102. doi: 10.3389/fneur.2023.1291102
  • Connor JR, Ponnuru P, Wang XS, et al. Profile of altered brain iron acquisition in restless legs syndrome. Brain. 2011;134(Pt 4):959–968. doi: 10.1093/brain/awr012
  • Thoppil MG, Kumar CS, Kumar A, et al. Speech signal analysis and pattern recognition in diagnosis of dysarthria. Ann Indian Acad Neur. 2017;20(4):352–357. doi: 10.4103/aian.AIAN_130_17
  • Reuter U, Israel H, Neeb L. The pharmacological profile and clinical prospects of the oral 5-HT1F receptor agonist lasmiditan in the acute treatment of migraine. Ther Adv Neurol Diso. 2015;8(1):46–54. doi: 10.1177/1756285614562419
  • Wang Y, Zhao Y, Liu X, et al. Chemical constituents and pharmacological activities of medicinal plants from Rosa genus. Chin Herb Med. 2022;14(2):187–209. doi: 10.1016/j.chmed.2022.01.005
  • Zhang W, Cui N, Ye J, et al. Curcumin’s prevention of inflammation-driven early gastric cancer and its molecular mechanism. Chin Herb Med. 2022;14(2):244–253. doi: 10.1016/j.chmed.2021.11.003
  • Liu X, Wang S, Li J, et al. Regulatory effect of traditional Chinese medicines on signaling pathways of process from chronic atrophic gastritis to gastric cancer. Chin Herb Med. 2022;14(1):5–19. doi: 10.1016/j.chmed.2021.10.008

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