Safety and Risk of Medication Overuse Headache in Lasmiditan and Second-Generation Gepants: A Rapid Review

References

• Burch RC, Buse DC, Lipton RB. Migraine: epidemiology, burden, and comorbidity. Neurol Clin. 2019;37(4):631–649. doi:10.1016/j.ncl.2019.06.001
   PubMed Web of Science ®Google Scholar
• Gilmore B, Michael M. Treatment of acute migraine headache. Am Fam Physician. 2011;83(3):271–280.
   PubMed Web of Science ®Google Scholar
• González-Hernández A, Marichal-Cancino BA, MaassenVanDenBrink A, Villalón CM. Side effects associated with current and prospective antimigraine pharmacotherapies. Expert Opin Drug Metab Toxicol. 2018;14(1):25–41. doi:10.1080/17425255.2018.1416097
   PubMed Web of Science ®Google Scholar
• Rapoport AM, Tepper SJ, Bigal ME, Sheftell FD. The triptan formulations: how to match patients and products. CNS Drugs. 2003;17(6):431–447. doi:10.2165/00023210-200317060-00005
   PubMed Web of Science ®Google Scholar
• Ong JJY, De Felice M. Migraine treatment: current acute medications and their potential mechanisms of action. Neurotherapeutics. 2018;15(2):274–290. doi:10.1007/s13311-017-0592-1
   PubMed Web of Science ®Google Scholar
• Headache classification committee of the International Headache Society (IHS) the international classification of headache disorders, 3rd edition. Cephalalgia. 2018;38(1):1–211. doi:10.1177/0333102417738202
   PubMed Web of Science ®Google Scholar
• Diener HC, Holle D, Solbach K, Gaul C. Medication-overuse headache: risk factors, pathophysiology and management. Nat Rev Neurol. 2016;12(10):575–583. doi:10.1038/nrneurol.2016.124
   PubMed Web of Science ®Google Scholar
• Ashina M, Ropper AH. Migraine. N Engl J Med. 2020;383(19):1866–1876. doi:10.1056/NEJMra1915327
   PubMed Web of Science ®Google Scholar
• Labastida-Ramírez A, Rubio-Beltrán 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
   PubMed Web of Science ®Google Scholar
• Watt A, Cameron A, Sturm L, et al. Rapid reviews versus full systematic reviews: an inventory of current methods and practice in health technology assessment. Int J Technol Assess Health Care. 2008;24(2):133–139. doi:10.1017/S0266462308080185
   PubMed Web of Science ®Google Scholar
• Ganann R, Ciliska D, Thomas H. Expediting systematic reviews: methods and implications of rapid reviews. Implement Sci. 2010;5(1):56. doi:10.1186/1748-5908-5-56
   PubMed Web of Science ®Google Scholar
• Khangura S, Konnyu K, Cushman R, et al. Evidence summaries: the evolution of a rapid review approach. Syst Rev. 2012;1(1):10. doi:10.1186/2046-4053-1-10
   PubMedGoogle Scholar
• Lal S, Adair CE. E-mental health: a rapid review of the literature. Psychiatr Serv. 2014;65(1):24–32. doi:10.1176/appi.ps.201300009
   PubMed Web of Science ®Google Scholar
• MaassenVanDenBrink A, van den Broek RW, de Vries R, Bogers AJ, Avezaat CJ, Saxena PR. Craniovascular selectivity of eletriptan and sumatriptan in human isolated blood vessels. Neurology. 2000;55(10):1524–1530. doi:10.1212/WNL.55.10.1524
   PubMed Web of Science ®Google Scholar
• MacIntyre PD, Bhargava B, Hogg KJ, Gemmill JD, Hillis WS. Effect of subcutaneous sumatriptan, a selective 5HT1 agonist, on the systemic, pulmonary, and coronary circulation. Circulation. 1993;87(2):401–405. doi:10.1161/01.CIR.87.2.401
   PubMed Web of Science ®Google Scholar
• Lucaites VL, Krushinski JH, Schaus JM, Audia JE, Nelson DL. [3H]LY334370, a novel radioligand for the 5-HT1F receptor. II. Autoradiographic localization in rat, Guinea pig, monkey and human brain. Naunyn Schmiedebergs Arch Pharmacol. 2005;371(3):178–184. doi:10.1007/s00210-005-1036-8
   PubMed Web of Science ®Google Scholar
• Ferrari A, Rustichelli C. Rational use of lasmiditan for acute migraine treatment in adults: a narrative review. Clin Ther. 2021;43(4):654–670. doi:10.1016/j.clinthera.2021.01.020
   Web of Science ®Google Scholar
• Färkkilä M, Diener HC, Gèraud G, et al. Efficacy and tolerability of lasmiditan, an oral 5-HT1F 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
   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. doi:10.1212/WNL.0000000000006641
   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. doi:10.1093/brain/awz134
   PubMed Web of Science ®Google Scholar
• Krege JH, Rizzoli PB, Liffick E, et al. Safety findings from Phase 3 lasmiditan studies for acute treatment of migraine: results from SAMURAI and SPARTAN. Cephalalgia. 2019;39(8):957–966. doi:10.1177/0333102419855080
   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. doi:10.1177/0333102419864132
   PubMed Web of Science ®Google 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. doi:10.1177/0333102421989232
   PubMed Web of Science ®Google Scholar
• Loo SL, Ailani J, Schim J, et al. Efficacy and safety of lasmiditan in patients using concomitant migraine preventive medications: findings from SAMURAI and SPARTAN, two randomized phase 3 trials. J Headache Pain. 2019;20(1):84. doi:10.1186/s10194-019-1032-x
   PubMed Web of Science ®Google Scholar
• Clemow DB, Baygani SK, Hauck PM, Hultman CB. Lasmiditan in patients with common migraine comorbidities: a post hoc efficacy and safety analysis of two phase 3 randomized clinical trials. Curr Med Res Opin. 2020;36(11):1791–1806. doi:10.1080/03007995.2020.1808780
   PubMed Web of Science ®Google Scholar
• Szkutnik-Fiedler D. Pharmacokinetics, pharmacodynamics and drug-drug interactions of new anti-migraine drugs-lasmiditan, gepants, and Calcitonin-Gene-Related Peptide (CGRP) receptor monoclonal antibodies. Pharmaceutics. 2020;12(12):1180. doi:10.3390/pharmaceutics12121180
   Web of Science ®Google Scholar
• Tsai M, Case M, Ardayfio P, Hochstetler H, Wilbraham D. Effects of lasmiditan on cardiovascular parameters and pharmacokinetics in healthy subjects receiving oral doses of propranolol. Clin Pharmacol Drug Dev. 2020;9(5):629–638. doi:10.1002/cpdd.768
   Web of Science ®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. doi:10.1002/hup.2732
   PubMed Web of Science ®Google Scholar
• Tsai M, Nery ESM, Kerr L, et al. Pharmacokinetics, safety, and tolerability of lasmiditan in pediatric patients with migraine. Clin Pharmacokinet. 2021;60(6):819–828. doi:10.1007/s40262-020-00966-z
   Web of Science ®Google Scholar
• Scott LJ. Ubrogepant: first approval. Drugs. 2020;80(3):323–328. doi:10.1007/s40265-020-01264-5
   PubMed Web of Science ®Google Scholar
• Chiang CC, VanderPluym JH. Ubrogepant in the acute management of migraine: a narrative review. J Pain Res. 2021;14:1185–1192. doi:10.2147/JPR.S244249
   Web of Science ®Google Scholar
• Voss T, Lipton RB, Dodick DW, et al. A phase IIb randomized, double-blind, placebo-controlled trial of ubrogepant for the acute treatment of migraine. Cephalalgia. 2016;36(9):887–898. doi:10.1177/0333102416653233
   PubMed Web of Science ®Google Scholar
• Lipton RB, Dodick DW, Ailani J, et al. Effect of ubrogepant vs placebo on pain and the most bothersome associated symptom in the acute treatment of migraine: the ACHIEVE II randomized clinical trial. JAMA. 2019;322(19):1887–1898. doi:10.1001/jama.2019.16711
   PubMed Web of Science ®Google Scholar
• Dodick DW, Lipton RB, Ailani J, et al. Ubrogepant for the treatment of migraine. N Engl J Med. 2019;381(23):2230–2241. doi:10.1056/NEJMoa1813049
   PubMed Web of Science ®Google Scholar
• Yang Y, Chen M, Sun Y, Gao B, Chen Z, Wang Z. Safety and efficacy of ubrogepant for the acute treatment of episodic migraine: a meta-analysis of randomized clinical trials. CNS Drugs. 2020;34(5):463–471. doi:10.1007/s40263-020-00715-7
   PubMed Web of Science ®Google Scholar
• Ailani J, Lipton RB, Hutchinson S, et al. Long-term safety evaluation of ubrogepant for the acute treatment of migraine: phase 3, randomized, 52-week extension trial. Headache. 2020;60(1):141–152. doi:10.1111/head.13682
   PubMed Web of Science ®Google Scholar
• Hutchinson S, Silberstein SD, Blumenfeld AM, et al. Safety and efficacy of ubrogepant in participants with major cardiovascular risk factors in two single-attack phase 3 randomized trials: ACHIEVE I and II. Cephalalgia. 2021;3331024211000311. doi:10.1177/03331024211000311
   Web of Science ®Google Scholar
• Goadsby PJ, Tepper SJ, Watkins PB, et al. Safety and tolerability of ubrogepant following intermittent, high-frequency dosing: randomized, placebo-controlled trial in healthy adults. Cephalalgia. 2019;39(14):1753–1761. doi:10.1177/0333102419869918
   PubMed Web of Science ®Google Scholar
• Jakate A, Blumenfeld AM, Boinpally R, et al. Pharmacokinetics and safety of ubrogepant when coadministered with calcitonin gene-related peptide-targeted monoclonal antibody migraine preventives in participants with migraine: a randomized Phase 1b drug-drug interaction study. Headache. 2021;61(4):642–652. doi:10.1111/head.14095
   PubMed Web of Science ®Google Scholar
• Jakate A, Boinpally R, Butler M, et al. Evaluation of the pharmacokinetic interaction and safety of ubrogepant coadministered with acetaminophen or nonsteroidal anti-inflammatory drugs: a randomized trial. Cephalalgia Rep. 2020;3:251581632092118. doi:10.1177/2515816320921186
   Google Scholar
• Jakate A, Boinpally R, Butler M, Lu K, McGeeney D, Periclou A. Evaluation of the pharmacokinetic interaction of ubrogepant coadministered with sumatriptan and of the safety of ubrogepant with triptans. Headache. 2020;60(7):1340–1350. doi:10.1111/head.13862
   PubMed Web of Science ®Google Scholar
• Li -C-C, Palcza J, Xu J, et al. The effect of multiple doses of ubrogepant on the pharmacokinetics of an oral contraceptive in healthy women: results of an open-label, single-center, two-period, fixed-sequence study. Cephalalgia Rep. 2020;3:251581632090508. doi:10.1177/2515816320905082
   Google Scholar
• Scott LJ. Rimegepant: first approval. Drugs. 2020;80(7):741–746. doi:10.1007/s40265-020-01301-3
   PubMed Web of Science ®Google Scholar
• DeFalco AP, Lazim R, Cope NE. Rimegepant orally disintegrating tablet for acute migraine treatment: a review. Ann Pharmacother. 2021;55(5):650–657. doi:10.1177/1060028020954800
   PubMed Web of Science ®Google Scholar
• Marcus R, Goadsby PJ, Dodick D, Stock D, Manos G, Fischer TZ. BMS-927711 for the acute treatment of migraine: a double-blind, randomized, placebo controlled, dose-ranging trial. Cephalalgia. 2014;34(2):114–125. doi:10.1177/0333102413500727
   PubMed Web of Science ®Google Scholar
• Croop R, Goadsby PJ, Stock DA, et al. Efficacy, safety, and tolerability of rimegepant orally disintegrating tablet for the acute treatment of migraine: a randomised, phase 3, double-blind, placebo-controlled trial. Lancet. 2019;394(10200):737–745. doi:10.1016/S0140-6736(19)31606-X
   PubMed Web of Science ®Google Scholar
• Lipton RB, Croop R, Stock EG, et al. Rimegepant, an oral calcitonin gene-related peptide receptor antagonist, for migraine. N Engl J Med. 2019;381(2):142–149. doi:10.1056/NEJMoa1811090
   PubMed Web of Science ®Google Scholar
• Gao B, Yang Y, Wang Z, et al. Efficacy and safety of rimegepant for the acute treatment of migraine: evidence from randomized controlled trials. Front Pharmacol. 2020;10:1577. doi:10.3389/fphar.2019.01577
   PubMed Web of Science ®Google Scholar
• Negro A, Martelletti P. Gepants for the treatment of migraine. Expert Opin Investig Drugs. 2019;28(6):555–567. doi:10.1080/13543784.2019.1618830
   PubMed Web of Science ®Google Scholar
• Croop R, Lipton RB, Kudrow D, et al. Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial. Lancet. 2021;397(10268):51–60. doi:10.1016/S0140-6736(20)32544-7
   PubMed Web of Science ®Google Scholar
• de Vries T, Al-Hassany L, MaassenVanDenBrink A. Evaluating rimegepant for the treatment of migraine. Expert Opin Pharmacother. 2021;22(8):973–979. doi:10.1080/14656566.2021.1895749
   PubMed Web of Science ®Google Scholar
• Croop R, Ivans A, Anderson MS, et al. A phase 1 randomized study of hemodynamic effects and pharmacokinetic interactions during concomitant use of rimegepant and sumatriptan in healthy adults. Cephalalgia Rep. 2021;4:251581632110079. doi:10.1177/25158163211007922
   Google Scholar
• Berman G, Croop R, Kudrow D, et al. Safety of rimegepant, an oral CGRP receptor antagonist, plus CGRP monoclonal antibodies for migraine. Headache. 2020;60(8):1734–1742. doi:10.1111/head.13930
   PubMed Web of Science ®Google Scholar
• van Hoogstraten WS, MaassenVanDenBrink A. The need for new acutely acting antimigraine drugs: moving safely outside acute medication overuse. J Headache Pain. 2019;20(1):54. doi:10.1186/s10194-019-1007-y
   Web of Science ®Google Scholar
• De Felice M, Ossipov MH, Wang R, et al. Triptan-induced latent sensitization: a possible basis for medication overuse headache. Ann Neurol. 2010;67(3):325–337. doi:10.1002/ana.21897
   Web of Science ®Google Scholar
• Belanger S, Ma W, Chabot JG, Quirion R. Expression of calcitonin gene-related peptide, substance P and protein kinase C in cultured dorsal root ganglion neurons following chronic exposure to mu, delta and kappa opiates. Neuroscience. 2002;115(2):441–453. doi:10.1016/S0306-4522(02)00452-9
   Web of Science ®Google Scholar
• Yisarakun W, Chantong C, Supornsilpchai W, et al. Up-regulation of calcitonin gene-related peptide in trigeminal ganglion following chronic exposure to paracetamol in a CSD migraine animal model. Neuropeptides. 2015;51:9–16. doi:10.1016/j.npep.2015.03.008
   Web of Science ®Google Scholar
• Yan H, Yu LC. Expression of calcitonin gene-related peptide receptor subunits in cultured neurons following morphine treatment. Neurosci Lett. 2013;544:52–55. doi:10.1016/j.neulet.2013.03.040
   Web of Science ®Google Scholar
• Kopruszinski CM, Xie JY, Eyde NM, et al. Prevention of stress- or nitric oxide donor-induced medication overuse headache by a calcitonin gene-related peptide antibody in rodents. Cephalalgia. 2017;37(6):560–570. doi:10.1177/0333102416650702
   PubMed Web of Science ®Google Scholar
• Tepper S, Ashina M, Reuter U, et al. Safety and efficacy of erenumab for preventive treatment of chronic migraine: a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol. 2017;16(6):425–434. doi:10.1016/S1474-4422(17)30083-2
   PubMed Web of Science ®Google Scholar
• Silberstein SD, Cohen JM, Seminerio MJ, Yang R, Ashina S, Katsarava Z. The impact of fremanezumab on medication overuse in patients with chronic migraine: subgroup analysis of the HALO CM study. J Headache Pain. 2020;21(1):114. doi:10.1186/s10194-020-01173-8
   PubMed Web of Science ®Google Scholar
• Dodick DW, Doty EG, Aurora SK, et al. Medication overuse in a subgroup analysis of phase 3 placebo-controlled studies of galcanezumab in the prevention of episodic and chronic migraine. Cephalalgia. 2021;41(3):340–352. doi:10.1177/0333102420966658
   PubMed Web of Science ®Google Scholar
• Scheffler A, Messel O, Wurthmann S, et al. Erenumab in highly therapy-refractory migraine patients: first German real-world evidence. J Headache Pain. 2020;21(1):84. doi:10.1186/s10194-020-01151-0
   PubMed Web of Science ®Google Scholar
• Lambru G, Hill B, Murphy M, Tylova I, Andreou AP. A prospective real-world analysis of erenumab in refractory chronic migraine. J Headache Pain. 2020;21(1):61. doi:10.1186/s10194-020-01127-0
   PubMed Web of Science ®Google Scholar
• Cainazzo MM, Baraldi C, Ferrari A, Lo Castro F, Pani L, Guerzoni S. Erenumab for the preventive treatment of chronic migraine complicated with medication overuse headache: an observational, retrospective, 12-month real-life study. Neurol Sci. 2021;42(10):4193–4202. doi:10.1007/s10072-021-05105-5
   PubMed Web of Science ®Google Scholar
• Saengjaroentham C, Strother LC, Dripps I, et al. Differential medication overuse risk of novel anti-migraine therapeutics. Brain. 2020;143(9):2681–2688. doi:10.1093/brain/awaa211
   PubMed Web of Science ®Google Scholar
• Navratilova E, Behravesh S, Oyarzo J, Dodick DW, Banerjee P, Porreca F. Ubrogepant does not induce latent sensitization in a preclinical model of medication overuse headache. Cephalalgia. 2020;40(9):892–902. doi:10.1177/0333102420938652
   PubMed Web of Science ®Google Scholar
• Rau JC, Navratilova E, Oyarzo J, et al. Evaluation of LY573144 (lasmiditan) in a preclinical model of medication overuse headache. Cephalalgia. 2020;40(9):903–912. doi:10.1177/0333102420920006
   PubMed Web of Science ®Google Scholar
• Lee MJ, Lee SY, Cho S, Kang ES, Chung CS. Feasibility of serum CGRP measurement as a biomarker of chronic migraine: a critical reappraisal. J Headache Pain. 2018;19(1):53. doi:10.1186/s10194-018-0883-x
   PubMed Web of Science ®Google Scholar
• Munksgaard SB, Ertsey C, Frandsen E, Bendtsen L, Tekes K, Jensen RH. Circulating nociceptin and CGRP in medication-overuse headache. Acta Neurol Scand. 2019;139(3):269–275. doi:10.1111/ane.13053
   PubMed Web of Science ®Google Scholar