Real world considerations for newly approved CGRP receptor antagonists in migraine care

References

• Stovner LJ, Nichols E, Steiner TJ. Global, regional, and national burden of migraine and tension-type headache, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2018 Nov;17(11):954–976.
   PubMed Web of Science ®Google Scholar
• Steiner TJ, Stovner LJ, Vos T, et al. Migraine is first cause of disability in under 50s: will health politicians now take notice? J Headache Pain. 2018 Feb 21;19(1):17.
   PubMed Web of Science ®Google Scholar
• Leonardi M, Grazzi L, D’Amico D, et al. Global burden of headache disorders in children and adolescents 2007–2017. Int J Environ Res Public Health. 2021;18(1):250.
   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.
   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. 2018/04/01.
   PubMed Web of Science ®Google Scholar
• Bigal ME, Liberman JN, Lipton RB. Age-dependent prevalence and clinical features of migraine. Neurology. 2006 Jul 25;67(2):246–251.
   PubMed Web of Science ®Google Scholar
• Bigal ME, Lipton RB. Clinical course in migraine: conceptualizing migraine transformation. Neurology. 2008 Sep 9;71(11):848–855.
   PubMed Web of Science ®Google Scholar
• Cameron C, Kelly S, Hsieh SC, et al. Triptans in the acute treatment of migraine: a systematic review and network meta-analysis. Headache. 2015 Jul-Aug;55(Suppl 4):221–235.
   PubMed Web of Science ®Google Scholar
• Ghanshani S, Chen C, Lin B, et al. Risk of acute myocardial infarction, heart failure, and death in migraine patients treated with triptans. Headache. 2020 Nov;60(10):2166–2175.
   PubMed Web of Science ®Google Scholar
• W M. A new generation of headache drugs. Nature. 2020;586(7829):S4–S6.
   Web of Science ®Google Scholar
• Capi M, De Angelis V, De Bernardini D, et al. CGRP receptor antagonists and 5-HT1F receptor agonist in the treatment of migraine. J Clin Med. 2021;10(7):1429.
   PubMed Web of Science ®Google Scholar
• Ubrelvy. Package insert. Allergan USA, Inc. 2019.
   Google Scholar
• Nurtec ODT. Package insert. Biohaven Pharmaceuticals Inc; 2020.
   Google Scholar
• Qulipta. Package insert. North Chicago (Ill): AbbVie Inc; 2021.
   Google Scholar
• Haut SR, Bigal ME, Lipton RB. Chronic disorders with episodic manifestations: focus on epilepsy and migraine. Lancet Neurol. 2006 Feb;5(2):148–157.
   PubMed Web of Science ®Google Scholar
• Ashina M, Hansen JM, Do TP, et al. Migraine and the trigeminovascular system—40 years and counting. Lancet Neurol. 2019;18(8):795–804. 2019/08/01.
   PubMed Web of Science ®Google Scholar
• Leao AA. Further observations on the spreading depression of activity in the cerebral cortex. J Neurophysiol. 1947 Nov;10(6):409–414.
   PubMed Web of Science ®Google Scholar
• Goadsby PJ, Lipton RB, Ferrari MD. Migraine–current understanding and treatment. N Engl J Med. 2002 Jan 24;346(4):257–270.
   PubMed Web of Science ®Google Scholar
• Hebestreit JM, May A. The enigma of site of action of migraine preventives: no effect of metoprolol on trigeminal pain processing in patients and healthy controls. J Headache Pain. 2017 Dec 19;18(1):116.
   PubMed Web of Science ®Google Scholar
• Denuelle M, Fabre N, Payoux P, et al. Hypothalamic activation in spontaneous migraine attacks. Headache. 2007 Nov-Dec;47(10):1418–1426.
   PubMed Web of Science ®Google Scholar
• Bartsch T, Levy MJ, Knight YE, et al. Differential modulation of nociceptive dural input to [hypocretin] orexin A and B receptor activation in the posterior hypothalamic area. Pain. 2004 Jun;109(3):367–378.
   PubMed Web of Science ®Google Scholar
• Stankewitz A, Keidel L, Rehm M, et al. Migraine attacks as a result of hypothalamic loss of control. NeuroImage Clin. 2021 Aug 16;32:102784.
   PubMed Web of Science ®Google Scholar
• Noseda R, Burstein R. Migraine pathophysiology: anatomy of the trigeminovascular pathway and associated neurological symptoms, CSD, sensitization and modulation of pain. Pain. 2013;154(Suppl 1):S44–S53.
   PubMed Web of Science ®Google Scholar
• Evans MS, Cheng X, Jeffry JA, et al. Sumatriptan inhibits TRPV1 channels in trigeminal neurons. Headache. 2012 May;52(5):773–784.
   PubMed Web of Science ®Google Scholar
• Porreca F, Ossipov MH, Gebhart GF. Chronic pain and medullary descending facilitation. Trends Neurosci. 2002 Jun;25(6):319–325.
   PubMed Web of Science ®Google Scholar
• Charbit AR, Akerman S, Goadsby PJ. Trigeminocervical complex responses after lesioning dopaminergic A11 nucleus are modified by dopamine and serotonin mechanisms. Pain. 2011 Oct;152(10):2365–2376.
   PubMed Web of Science ®Google Scholar
• Amara SG, Jonas V, Rosenfeld MG, et al. Alternative RNA processing in calcitonin gene expression generates mRNAs encoding different polypeptide products. Nature. 1982 Jul 15;298(5871):240–244.
   PubMed Web of Science ®Google Scholar
• Scuteri D, Adornetto A, Rombolà L, et al. Pattern of triptans use: a retrospective prescription study in Calabria, Italy. Neural Regen Res. 2020 Jul;15(7):1340–1343.
   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. 2020/06/10.
   PubMed Web of Science ®Google Scholar
• Berger AA, Winnick A, Popovsky D, et al. Lasmiditan for the treatment of migraines with or without aura in adults. Psychopharmacol Bull. 2020 Oct 15;50(4 Suppl 1):163–188.
   PubMedGoogle Scholar
• Goadsby PJ, Edvinsson L, Ekman R. Vasoactive peptide release in the extracerebral circulation of humans during migraine headache. Ann Neurol. 1990 Aug;28(2):183–187.
   PubMed Web of Science ®Google Scholar
• Poyner D. Pharmacology of receptors for calcitonin gene-related peptide and amylin. Trends Pharmacol Sci. 1995 Dec;16(12):424–428.
   PubMed Web of Science ®Google Scholar
• Poyner DR. Molecular pharmacology of receptors for calcitonin-gene-related peptide, amylin and adrenomedullin. Biochem Soc Trans. 1997 Aug;25(3):1032–1036.
   PubMed Web of Science ®Google Scholar
• Goadsby PJ, Holland PR, Martins-Oliveira M, et al. Pathophysiology of migraine: a disorder of sensory processing. Physiol Rev. 2017 Apr;97(2):553–622.
   PubMed Web of Science ®Google Scholar
• Walker CS, Conner AC, Poyner DR, et al. Regulation of signal transduction by calcitonin gene-related peptide receptors. Trends Pharmacol Sci. 2010 Oct;31(10):476–483.
   PubMed Web of Science ®Google Scholar
• Scuteri D, Adornetto A, Rombolà L, et al. New trends in migraine pharmacology: targeting Calcitonin Gene-Related Peptide (CGRP) with monoclonal antibodies. Front Pharmacol. 2019;10:363.
   PubMed Web of Science ®Google Scholar
• Martelletti P, Edvinsson L, Ashina M. Shaping the future of migraine targeting calcitonin-gene-related-peptide with the Disease-Modifying Migraine Drugs (DMMDs). J Headache Pain. 2019 May 23;20(1):60.
   PubMed Web of Science ®Google Scholar
• Chiba T, Yamaguchi A, Yamatani T, et al. Calcitonin gene-related peptide receptor antagonist human CGRP-(8-37). A J Physiol. 1989 Feb;256(2 Pt 1):E331–5.
   PubMed Web of Science ®Google Scholar
• Rist B, Lacroix JS, Entzeroth M, et al. CGRP 27-37 analogues with high affinity to the CGRP1 receptor show antagonistic properties in a rat blood flow assay. Regul Pept. 1999 Feb 5;79(2–3):153–158.
   PubMedGoogle Scholar
• Olesen J, Diener HC, Husstedt IW, et al. Calcitonin gene-related peptide receptor antagonist BIBN 4096 BS for the acute treatment of migraine. N Engl J Med. 2004 Mar 11;350(11):1104–1110.
   PubMed Web of Science ®Google Scholar
• Ho TW, Connor KM, Zhang Y, et al. Randomized controlled trial of the CGRP receptor antagonist telcagepant for migraine prevention. Neurology. 2014 Sep 9;83(11):958–966.
   PubMed Web of Science ®Google Scholar
• Ho TW, Ho AP, Chaitman BR, et al. Randomized, controlled study of telcagepant in patients with migraine and coronary artery disease. Headache. 2012 Feb;52(2):224–235.
   PubMed Web of Science ®Google Scholar
• Chaitman BR, Ho AP, Behm MO, et al. A randomized, placebo-controlled study of the effects of telcagepant on exercise time in patients with stable angina. Clin Pharmacol Ther. 2012 Mar;91(3):459–466.
   PubMed Web of Science ®Google Scholar
• Diener HC, 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 May;39(6):687–710.
   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 Aug 31;394(10200):737–745.
   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 Dec 5;381(23):2230–2241.
   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 Nov 19;322(19):1887–1898.
   PubMed Web of Science ®Google Scholar
• Temple R. Hy’s law: predicting serious hepatotoxicity. Pharmacoepidemiol Drug Saf. 2006 Apr;15(4):241–243.
   PubMed Web of Science ®Google Scholar
• Lionetto L, Capi M, Curto M, et al. Rimegepant. Calcitonin gene-related peptide (CGRP) receptor antagonist, treatment of migraine [Monograph]. Drugs Future. 2019;44(8):635–642.
   Web of Science ®Google Scholar
• Negro A, Martelletti P. Rimegepant for the treatment of migraine. Drugs Today. 2020 Dec;56(12):769–780.
   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 Jul 11;381(2):142–149.
   PubMed Web of Science ®Google Scholar
• Goadsby PJ, Dodick DW, Ailani J, et al. Safety, tolerability, and efficacy of orally administered atogepant for the prevention of episodic migraine in adults: a double-blind, randomised phase 2b/3 trial. Lancet Neurol. 2020 Sep;19(9):727–737.
   PubMed Web of Science ®Google Scholar
• Martelletti P, Cipolla F, Capi M, et al. Atogepant. Calcitonin gene-related peptide (CGRP) receptor antagonist, preventive treatment of migraine [Monograph]. Drugs Future. 2020;45(5):285–297.
   Web of Science ®Google Scholar
• Ailani J, Lipton RB, Goadsby PJ, et al. Atogepant for the preventive treatment of migraine. N Engl J Med. 2021 Aug 19;385(8):695–706.
   PubMed Web of Science ®Google Scholar
• Dubowchik GM, Conway CM, Xin AW. Blocking the CGRP pathway for acute and preventive treatment of migraine: the evolution of success. J Med Chem. 2020 Jul 9;63(13):6600–6623.
   PubMed Web of Science ®Google Scholar
• Moreno-Ajona D, Pérez-Rodríguez A, Goadsby PJ, Small-molecule CGRP receptor antagonists: a new approach to the acute and preventive treatment of migraine. Medicine in Drug Discovery. 2020 2020/09/01;7. 100053.
   Google Scholar
• Cipolla F, Capi M, Lionetto L, et al. Zavegepant. Calcitonin gene-related peptide (CGRP) receptor antagonist, Treatment of migraine [Monograph]. Drugs Future. 2021;46(4):1–8. (Advanced Publication).
   Web of Science ®Google Scholar
• Chaturvedula PV, Mercer SE, Pin SS, et al. Discovery of (R)-N-(3-(7-methyl-1H-indazol-5-yl)-1-(4-(1-methylpiperidin-4-yl)-1-oxopropan-2-yl)-4-(2-oxo-1,2-dihydroquinolin-3-yl)piperidine-1-carboxamide (BMS-742413): a potent human CGRP antagonist with superior safety profile for the treatment of migraine through intranasal delivery. Bioorg Med Chem Lett. 2013;23(11):3157–3161. 2013/06/01.
   PubMed Web of Science ®Google Scholar
• Mercer SE, Chaturvedula PV, Conway CM, et al. Azepino-indazoles as calcitonin gene-related peptide (CGRP) receptor antagonists. Bioorg Med Chem Lett. 2021 2021/01/01;31:127624.
   PubMed Web of Science ®Google Scholar
• www.prnewswire.com/news-releases/biohaven-reports-positive-topline-results-from-pivotal-migraine-trial-of-intranasal-zavegepant-demonstrating-ultra-rapid-pain-relief-by-15-minutes-prepares-for-submission-of-new-drug-application-301437767.html.
   Google Scholar
• Štekláč M, Zajaček D, Bučinský L. 3CL(pro) and PL(pro) affinity, a docking study to fight COVID19 based on 900 compounds from PubChem and literature. Are there new drugs to be found? J Mol Struct. 2021 Dec 5;1245:130968.
   PubMed Web of Science ®Google Scholar
• Martelletti P. An unexpected and suspended time. J Headache Pain. 2020 Apr 22;21(1):36.
   PubMed Web of Science ®Google Scholar
• (ICER) IfCaER. Final evidence report and report-at-a-glance assessing the comparative clinical effectiveness and economic value of three acute treatments for migraine: lasmiditan (Reyvow™, Eli Lilly), rimegepant (Biohaven), and ubrogepant (Ubrelvy™, Allergan). 2020.
   Google Scholar
• Moreno-Ajona D, Pérez-Rodríguez A, Goadsby PJ. Gepants, calcitonin-gene-related peptide receptor antagonists: what could be their role in migraine treatment? Curr Opin Neurol. 2020 Jun;33(3):309–315.
   PubMed Web of Science ®Google Scholar
• Scuteri D, Corasaniti MT, Tonin P, et al. Role of CGRP pathway polymorphisms in migraine: a systematic review and impact on CGRP mAbs migraine therapy. J Headache Pain. 2021 Jul 30;22(1):87.
   PubMed Web of Science ®Google Scholar
• Scuteri D, Vulnera M, Piro B, et al. Pattern of treatment of behavioural and psychological symptoms of dementia and pain: evidence on pharmacoutilization from a large real-world sample and from a centre for cognitive disturbances and dementia. Eur J Clin Pharmacol. 2021 Feb;77(2):241–249.
   PubMed Web of Science ®Google Scholar
• Scuteri D, Garreffa MR, Esposito S, et al. Evidence for accuracy of pain assessment and painkillers utilization in neuropsychiatric symptoms of dementia in Calabria region, Italy. Neural Regen Res. 2018 Sep;13(9):1619–1621.
   PubMed Web of Science ®Google Scholar
• Scuteri D, Piro B, Morrone LA, et al. The need for better access to pain treatment: learning from drug consumption trends in the USA. Funct Neurol. 2017 October/December;22(4):229–230.
   PubMed Web of Science ®Google Scholar
• Scuteri D, Matamala-Gomez M, Bottiroli S, et al. Pain assessment and treatment in dementia at the time of coronavirus disease COVID-19. Front Neurol. 2020;11:890.
   PubMed Web of Science ®Google Scholar
• McKinley EC, Lay CL, Rosenson RS, et al. Risk for ischemic stroke and coronary heart disease associated with migraine and migraine medication among older adults. J Headache Pain. 2021;22(1):124. 2021/10/13.
   PubMed Web of Science ®Google Scholar
• Scuteri D, Corasaniti MT, Tonin P, et al. Eptinezumab for the treatment of migraine. Drugs Today. 2019 Nov;55(11):695–703.
   PubMed Web of Science ®Google Scholar
• Winner PK, McAllister P, Chakhava G, et al. Effects of intravenous eptinezumab vs placebo on headache pain and most bothersome symptom when initiated during a migraine attack: a randomized clinical trial. Jama. 2021 Jun 15;325(23):2348–2356.
   PubMed Web of Science ®Google Scholar
• Scuteri D, Bagetta G. Progress in the treatment of migraine attacks: from traditional approaches to eptinezumab. Pharmaceuticals (Basel). 2021 Sep 13;14(9). https://doi.org/10.3390/ph14090924.
   Google Scholar
• Rapoport AM, Lipton RB. Potassium channel openers - novel triggers of aura and migraine. Nat Rev Neurol. 2021 Jul;17(7):397–398.
   PubMed Web of Science ®Google Scholar
• Parlar A, Arslan SO, Çam SA. Glabridin alleviates inflammation and nociception in rodents by activating BK(Ca) channels and reducing NO levels. Biol Pharm Bull. 2020 May 1;43(5):884–897.
   PubMed Web of Science ®Google Scholar
• Scuteri D, Crudo M, Rombolà L, et al. Antinociceptive effect of inhalation of the essential oil of bergamot in mice. Fitoterapia. 2018 Sep;129:20–24.
   PubMed Web of Science ®Google Scholar
• Scuteri D, Rombolá L, Tridico L, et al. Neuropharmacological properties of the essential oil of bergamot for the clinical management of pain-related BPSDs. Curr Med Chem. 2019;26(20):3764–3774.
   PubMed Web of Science ®Google Scholar
• Scuteri D, Rombolà L, Morrone LA, et al. Neuropharmacology of the neuropsychiatric symptoms of dementia and role of pain: essential oil of bergamot as a novel therapeutic approach. Int J Mol Sci. 2019 Jul 6;20(13):3327.
   Web of Science ®Google Scholar
• Scuteri D, Sandrini G, Tamburin S, et al. Bergamot rehabilitation AgaINst agitation in dementia (BRAINAID): study protocol for a randomized, double-blind, placebo-controlled trial to assess the efficacy of furocoumarin-free bergamot loaded in a nanotechnology-based delivery system of the essential oil in the treatment of agitation in elderly affected by severe dementia. Phytother Res. 2021 Oct;35(10):5333–5338.
   PubMed Web of Science ®Google Scholar
• Rombolà L, Scuteri D, Watanabe C, et al. Role of 5-HT1A receptor in the anxiolytic-relaxant effects of bergamot essential oil in rodent. Int J Mol Sci. 2020 Apr 9;21(7):2597.
   Web of Science ®Google Scholar
• Rombolà L, Scuteri D, Adornetto A, et al. Anxiolytic-like effects of bergamot essential oil are insensitive to flumazenil in rats. Evid Based Complement Alternat Med. 2019;2019:2156873.
   PubMed Web of Science ®Google Scholar
• Scuteri D, Cassano R, Trombino S, et al. Development and translation of NanoBEO, a nanotechnology-based delivery system of bergamot essential oil deprived of furocumarins, in the control of agitation in severe dementia. Pharmaceutics. 2021 Mar 12;13(3):379.
   PubMed Web of Science ®Google Scholar