Lasmiditan for single migraine attack in Japanese patients with cardiovascular risk factors: subgroup analysis of a phase 2 randomized placebo-controlled trial

References

• Sakai F, Igarashi H. Prevalence of migraine in Japan: a nationwide survey. Cephalalgia. 1997;17(1):15–22.
   PubMed Web of Science ®Google Scholar
• Hirata K, Ueda K, Komori M, et al. Comprehensive population-based survey of migraine in Japan: results of the ObserVational Survey of the Epidemiology, tReatment, and Care of MigrainE (OVERCOME [Japan]) study. Curr Med Res Opin. 2021;37(11):1945–1955.
   PubMed Web of Science ®Google Scholar
• Igarashi H, Ueda K, Jung S, et al. Social burden of people with the migraine diagnosis in Japan: evidence from a population-based cross-sectional survey. BMJ Open. 2020;10(11):e038987.
   PubMed Web of Science ®Google Scholar
• Hirata K, Ueda K, Ye W, et al., Factors associated with insufficient response to acute treatment of migraine in Japan: analysis of real-world data from the Adelphi Migraine Disease Specific Programme. BMC Neurol. 20(1): 274. 2020.
   PubMed Web of Science ®Google Scholar
• Japanese Society of Neurology and the Japanese Headache Society. Clinical practice guideline for chronic headache. 2013 [cited 2021 Mar 30]. Available from: https://www.neurology-jp.org/guidelinem/ch/documents/preface.pdf
   Google Scholar
• González-Hernández A, Marichal-Cancino BA, MaassenVanDenBrink A, et al. Side effects associated with current and prospective antimigraine pharmacotherapies. Expert Opin Drug Metab Toxicol. 2018;14(1):25–41.
   PubMed Web of Science ®Google Scholar
• Dodick D, Lipton RB, Martin V, et al. Consensus statement: cardiovascular safety profile of triptans (5-HT agonists) in the acute treatment of migraine. Headache. 2004;44(5):414–425.
   PubMed Web of Science ®Google Scholar
• Shapiro RE, Hochstetler HM, Dennehy EB, et al., Lasmiditan for acute treatment of migraine in patients with cardiovascular risk factors: post-hoc analysis of pooled results from 2 randomized, double-blind, placebo-controlled, phase 3 trials. J Headache Pain. 20(1): 90. 2019.
   PubMed Web of Science ®Google Scholar
• Lipton RB, Reed ML, Kurth T, et al., Framingham-based cardiovascular risk estimates among people with episodic migraine in the US population: results from the American Migraine Prevalence and Prevention (AMPP) study. Headache. 57(10): 1507–1521. 2017.
   PubMed Web of Science ®Google Scholar
• Clemow DB, Johnson KW, Hochstetler HM, et al. Lasmiditan mechanism of action - review of a selective 5-HT1F agonist. J Headache Pain. 2020;21(1):71.
   PubMed Web of Science ®Google Scholar
• Nelson DL, Phebus LA, Johnson KW, et al. Preclinical pharmacological profile of the selective 5-HT1F receptor agonist lasmiditan. Cephalalgia. 2010;30(10):1159–1169.
   PubMed Web of Science ®Google Scholar
• Tfelt-Hansen PC, Olesen J. The 5-HT1F receptor agonist lasmiditan as a potential treatment of migraine attacks: a review of two placebo-controlled phase II trials. J Headache Pain. 2012;13(4):271–275.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Goadsby PJ, Wietecha LA, Dennehy EB, et al. Phase 3 randomized, placebo-controlled, double-blind study of lasmiditan for acute treatment of migraine. Brain. 2019;142(7):1894–1904.
   PubMed Web of Science ®Google Scholar
• Kuca B, Silberstein SD, Wietecha L, et al. Lasmiditan is an effective acute treatment for migraine: a phase 3 randomized study. Neurology. 2018;91(24):e2222–e2232.
   PubMed Web of Science ®Google Scholar
• Lipton RB, Lombard L, Ruff DD, et al. Trajectory of migraine-related disability following long-term treatment with lasmiditan: results of the GLADIATOR study. J Headache Pain. 2020;21(1):20.
   PubMed Web of Science ®Google Scholar
• Sakai F, Takeshima T, Homma G, et al., Phase 2 randomized placebo-controlled study of lasmiditan for the acute treatment of migraine in Japanese patients. Headache. 61(5): 755–765. 2021.
   PubMed Web of Science ®Google Scholar
• Joint Committee for Comprehensive Risk Management Chart for the Prevention of Cerebro-Cardiovascular Diseases. Comprehensive risk management for the prevention of cerebro-cardiovascular diseases in Japan. J Atheroscler Thromb. 2017;24(7):749–764.
   PubMed Web of Science ®Google Scholar
• Diener H-C, Tassorelli C, Dodick DW, et al. Guidelines of the International Headache Society for controlled trials of acute treatment of migraine attacks in adults: fourth edition. Cephalalgia. 2019;39(6):687–710.
   PubMed Web of Science ®Google Scholar
• Buse DC, Reed ML, Fanning KM, et al. Cardiovascular events, conditions, and procedures among people with episodic migraine in the US population: results from the American Migraine Prevalence and Prevention (AMPP) study. Headache. 2017;57(1):31–44.
   PubMed Web of Science ®Google Scholar
• Iso H. Lifestyle and cardiovascular disease in Japan. J Atheroscler Thromb. 2011;18(2):83–88.
   PubMed Web of Science ®Google Scholar
• Hirata K, Matsumori Y, Tanji Y, et al. Safety profile of lasmiditan: phase 2 study for a single migraine attack in Japanese patients. Expert Opin Drug Saf. 2021;20:721–733. in review
   PubMedGoogle Scholar
• Ashina M, Reuter U, Smith T, et al. Randomized, controlled trial of lasmiditan over four migraine attacks: findings from the CENTURION study. Cephalalgia. 2021;41(3):294–304.
   PubMed Web of Science ®Google Scholar
• Hou M, Xing H, Li C, et al. Short-term efficacy and safety of lasmiditan, a novel 5-HT1F receptor agonist, for the acute treatment of migraine: a systematic review and meta-analysis. J Headache Pain. 2020;21(1):66.
   PubMed Web of Science ®Google Scholar
• Food and Drug Administration. Evaluating drug effects on the ability to operate a motor vehicle: guidance for industry 2017. 2017. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/evaluating-drug-effects-ability-operate-motor-vehicle
   Google Scholar
• Pearlman EM, Wilbraham D, Dennehy EB, et al. Effects of lasmiditan on simulated driving performance: results of two randomized, blinded, crossover studies with placebo and active controls. Hum Psychopharmacol. 2020;35(5):e2732–e2732.
   PubMed Web of Science ®Google Scholar