期刊论文详细信息
BMC Medicine
New players in the preventive treatment of migraine
Alan M. Rapoport1  Dimos D. Mitsikostas2 
[1] 4255 Jefferson Avenue, Suite 27, Woodside, California 94062, CA, USA;Neurology Department, Athens Naval Hospital, 70 Dinokratous Street, Athens, 11521, Greece
关键词: Supraorbital and supratrochlear nerve stimulation;    Vagus nerve stimulation;    Neuromodulation;    Neurostimulation;    Monoclonal antibodies;    CGRP;    Prevention;    Cluster headache;    Migraine;   
Others  :  1233463
DOI  :  10.1186/s12916-015-0522-1
 received in 2015-07-07, accepted in 2015-11-02,  发布年份 2015
PDF
【 摘 要 】

Migraine is a common, chronic disorder of the brain causing much disability, as well as personal, familial and societal impact. Several oral preventive agents are available in different countries for the prevention of migraine, but none have performed better than 50 % improvement in 50 % of patients in a clinical trial. Additionally, each has various possible adverse events making their tolerability less than optimal. Recently, three monoclonal antibodies targeting the calcitonin gene-related peptide (CGRP) ligand (LY2951742, ALD403 and TEV-48125) and one targeting the CGRP receptor (AMG 334) have completed phase 2 trials, and the results have been reported. These early results show them all to be somewhat more effective than placebo, with no serious adverse events. Three have been studied for episodic migraine, and only TEV-48125 has been studied for both high frequency episodic and chronic migraine. Moreover, preliminary data suggests that neurostimulation is effective in migraine treatment, including stimulation of the sphenopalatine ganglion, transcutaneous supraorbital and supratrochlear nerve, and transcutaneous vagus nerve. In this article, these innovative therapies will be reviewed.

【 授权许可】

   
2015 Mitsikostas and Rapoport.

【 预 览 】
附件列表
Files Size Format View
20151121024240662.pdf 446KB PDF download
【 参考文献 】
  • [1]Lipton RB, Bigal ME, Diamond M, Freitag F, Reed ML, Stewart WF et al.. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2007; 68:343-9.
  • [2]Lantéri-Minet M, Duru G, Mudge M, Cottrell S. Quality of life impairment, disability and economic burden associated with chronic daily headache, focusing on chronic migraine with or without medication overuse: a systematic review. Cephalalgia. 2011; 31:837-50.
  • [3]Mitsikostas DD, Thomas AM. Comorbidity of headache and depressive disorders. Cephalalgia. 1999; 19:211-7.
  • [4]The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013; 33:629-808.
  • [5]Lipton RB, Silberstein SD. Episodic and chronic migraine headache: breaking down barriers to optimal treatment and prevention. Headache. 2015; 55 Suppl 2:103-22.
  • [6]Abu Bakar N, Tanprawate S, Lambru G, Torkamani M, Jahanshahi M, Matharu M. Quality of life in primary headache disorders: a review. Cephalalgia. 2015. [Epub ahead of print].
  • [7]Erdélyi-Bótor S, Aradi M, Kamson DO, Kovács N, Perlaki G, Orsi G et al.. Changes of migraine-related white matter hyperintensities after 3 years: a longitudinal MRI study. Headache. 2015; 55:55-70.
  • [8]Global, regional, and national incidence, prevalence, and years lived with disability for 301 acute and chronic diseases and injuries in 188 countries, 1990–2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015; 386(9995):743-800.
  • [9]Steiner TJ, Birbeck GL, Jensen RH, Katsarava Z, Stovner LJ, Martelletti P. Headache disorders are third cause of disability worldwide. J Headache Pain. 2015; 16:58. BioMed Central Full Text
  • [10]Silberstein SD, Holland S, Freitag F, Dodick DW, Argoff C, Ashman E et al.. Evidence-based guideline update: pharmacologic treatment for episodic migraine prevention in adults: report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Neurology. 2012; 78:1337-45.
  • [11]Evers S, Afra J, Frese A, Goadsby PJ, Linde M, May A et al.. EFNS guideline on the drug treatment of migraine-revised report of an EFNS task force. Eur J Neurol. 2009; 16:968-81.
  • [12]Evers S, Jensen R. Treatment of medication overuse headache-guideline of the EFNS headache panel. Eur J Neurol. 2011; 18:1115-21.
  • [13]Dodick DW, Turkel CC, DeGryse RE, Aurora SK, Silberstein SD, Lipton RB et al.. OnabotulinumtoxinA for treatment of chronic migraine: pooled results from the double-blind, randomized, placebo-controlled phases of the PREEMPT clinical program. Headache. 2010; 50:921-36.
  • [14]Lipton RB, Silberstein S, Dodick D, Cady R, Freitag F, Mathew N et al.. Topiramate intervention to prevent transformation of episodic migraine: the topiramate INTREPID study. Cephalalgia. 2011; 31:18-30.
  • [15]Diener HC, Bussone G, Van Oene JC, Lahaye M, Schwalen S, Goadsby PJ et al.. Topiramate reduces headache days in chronic migraine: a randomized, double-blind, placebo-controlled study. Cephalalgia. 2007; 27:814-23.
  • [16]Grazzi L, Andrasik F. Non-pharmacological approaches in migraine prophylaxis: behavioral medicine. Neurol Sci. 2010; 31 Suppl 1:S133-5.
  • [17]Linde M, Mulleners WM, Chronicle EP, McCrory DC. Valproate (valproic acid or sodium valproate or a combination of the two) for the prophylaxis of episodic migraine in adults. Cochrane Database Syst Rev. 2013; 6:CD010611.
  • [18]Linde M, Mulleners WM, Chronicle EP, McCrory DC. Topiramate for the prophylaxis of episodic migraine in adults. Cochrane Database Syst Rev. 2013; 6:CD010610.
  • [19]Luykx J, Mason M, Ferrari MD, Carpay J. Are migraineurs at increased risk of adverse drug responses? A meta-analytic comparison of topiramate-related adverse drug reactions in epilepsy and migraine. Clin Pharmacol Ther. 2009; 85:283-8.
  • [20]Gracia-Naya M, Santos-Lasaosa S, Ríos-Gómez C, Sánchez-Valiente S, García-Gomara MJ, Latorre-Jiménez AM et al.. Predisposing factors affecting drop-out rates in preventive treatment in a series of patients with migraine. Rev Neurol. 2011; 53:201-8.
  • [21]Mitsikostas DD, Mantonakis LI, Chalarakis NG. Nocebo is the enemy, not placebo. A meta-analysis of reported side effects after placebo treatment in headaches. Cephalalgia. 2011; 31:550-61.
  • [22]Mitsikostas DD. Nocebo in headaches: implications for clinical practice and trial design. Curr Neurol Neurosci Rep. 2012; 12:132-7.
  • [23]Hepp Z, Dodick DW, Varon SF, Gillard P, Hansen RN, Devine EB. Adherence to oral migraine-preventive medications among patients with chronic migraine. Cephalalgia. 2015; 35:478-88.
  • [24]Karsan N, Goadsby PJ. CGRP mechanism antagonists and migraine management. Curr Neurol Neurosci Rep. 2015; 15:25.
  • [25]Zeller J, Poulsen KT, Sutton JE, Abdiche YN, Collier S, Chopra R et al.. CGRP function-blocking antibodies inhibit neurogenic vasodilatation without affecting heart rate or arterial blood pressure in the rat. Br J Pharmacol. 2008; 155:1093-103.
  • [26]Juhl L, Edvinsson L, Olesen J, Jansen-Olesen I. Effect of two novel CGRP-binding compounds in a closed cranial window rat model. Eur J Pharmacol. 2007; 567:117-24.
  • [27]Walter S, Alibhoy A, Escandon R, Bigal ME. Evaluation of cardiovascular parameters in cynomolgus monkeys following IV administration of LBR-101, a monoclonal antibody against calcitonin gene-related peptide. MAbs. 2014; 6:871-8.
  • [28]Bigal ME, Walter S, Rapoport AM. Calcitonin gene-related peptide (CGRP) and migraine current understanding and state of development. Headache. 2013; 53:1230-44.
  • [29]Descotes J. Immunotoxicity of monoclonal antibodies. MAbs. 2009; 1:104-11.
  • [30]Bigal ME, Walter S, Bronson M, Alibhoy A, Escandon R. Cardiovascular and hemodynamic parameters in women following prolonged CGRP inhibition using LBR-101, a monoclonal antibody against CGRP. Cephalalgia. 2014; 34:968-76.
  • [31]Bigal ME, Escandon R, Bronson M, Walter S, Sudworth M, Huggins JP et al.. Safety and tolerability of LBR-101, a humanized monoclonal antibody that blocks the binding of CGRP to its receptor: results of the Phase 1 program. Cephalalgia. 2013; 34:483-492.
  • [32]Dodick DW, Goadsby PJ, Silberstein SD, Lipton RB, Olesen J, Ashina M et al.. Safety and efficacy of ALD403, an antibody to calcitonin gene-related peptide, for the prevention of frequent episodic migraine: a randomized, double-blind, placebo-controlled, exploratory phase 2 trial. Lancet Neurol. 2014; 13:1100-7.
  • [33]Dodick DW, Goadsby PJ, Spierings EL, Scherer JC, Sweeney SP, Grayzel DS. Safety and efficacy of LY2951742, a monoclonal antibody to calcitonin gene-related peptide, for the prevention of migraine: a phase 2, randomized, double-blind, placebo-controlled study. Lancet Neurol. 2014; 13:885-92.
  • [34]Lenz R, Silberstein S, Dodick D, Reuter U, Ashina M, Saper J et al.. Results of a randomized, double-blind, placebo-controlled, phase 2 study to evaluate the efficacy and safety of AMG 334 for the prevention of episodic migraine. 17th Congress of the International Headache Society, Valencia; 2015.
  • [35]Bigal ME, Dodick DW, Rapoport AM, Silberstein SD, Ma Y, Yang R et al.. Safety, tolerability, and efficacy of TEV-48125 for preventive treatment of high-frequency episodic migraine: a multicentre, randomised, double-blind, placebo-controlled, phase 2b study. Lancet Neurol. 2015; 14(11):1081-90.
  • [36]Bigal ME, Edvinsson L, Rapoport AM, Lipton RB, Spierings EL, Diener HC et al.. Safety, tolerability, and efficacy of TEV-48125 for preventive treatment of chronic migraine: a multicentre, randomised, double-blind, placebo-controlled, phase 2b study. Lancet Neurol. 2015; 14(11):1091-100.
  • [37]Shamliyan TA, Choi JY, Ramakrishnan R, Miller JB, Wang SY, Taylor FR et al.. Preventive pharmacologic treatments for episodic migraine in adults. J Gen Intern Med. 2013; 28:1225-37.
  • [38]Bertolotto A. Evaluation of the impact of neutralizing antibodies on IFNβ response. Clin Chim Acta. 2015; 449:31-6.
  • [39]Seng EK, Rains JA, Nicholson RA, Lipton RB. Improving medication adherence in migraine treatment. Curr Pain Headache Rep. 2015; 19(6):498.
  • [40]Berger A, Bloudek LM, Varon SF, Oster G. Adherence with migraine prophylaxis in clinical practice. Pain Pract. 2012; 12:541-9.
  • [41]Ho TW, Ho AP, Ge YJ, Assaid C, Gottwald R, MacGregor EA, et al. Randomized controlled trial of the CGRP receptor antagonist telcagepant for prevention of headache in women with perimenstrual migraine. Cephalalgia. 2015. [Epub ahead of print].
  • [42]Ho TW, Connor KM, Zhang Y, Pearlman E, Koppenhaver J, Fan X et al.. Randomized controlled trial of the CGRP receptor antagonist telcagepant for migraine prevention. Neurology. 2014; 83:958-66.
  • [43]Deer TR, Mekhail N, Petersen E, Krames E, Staats P, Pope J et al.. The appropriate use of neurostimulation: stimulation of the intracranial and extracranial space and head for chronic pain. Neuromodulation Appropriateness Consensus Committee. Neuromodulation. 2014; 17:551-70.
  • [44]Ambrosini A, D'Alessio C2, Magis D, Schoenen J. Targeting pericranial nerve branches to treat migraine: Current approaches and perspectives. Cephalalgia. 2015. [Epub ahead of print].
  • [45]Schoenen J, Vandersmissen B, Jeangette S, Herroelen L, Vandenheede M, Gérard P et al.. Migraine prevention with a supraorbital transcutaneous stimulator: A randomized controlled trial. Neurology. 2013; 80:697-704.
  • [46]Magis D, Sava S, d’Elia TS, Baschi R, Schoenen J. Safety and patients’ satisfaction of transcutaneous supraorbital neurostimulation (tSNS) with the Cefaly device in headache treatment: A survey of 2,313 headache sufferers in the general population. J Headache Pain. 2013; 14:95. BioMed Central Full Text
  • [47]Russo A, Tessitore A, Conte F, Marcuccio L, Giordano A, Tedeschi G. Transcutaneous supraorbital neurostimulation in “de novo” patients with migraine without aura: the first Italian experience. J Headache Pain. 2015; 16:69. BioMed Central Full Text
  • [48]Silberstein SD, Neves da Silva A, Calhoun AH, Grosberg BM, Lipton RB, Cady RK et al.. Non-invasive vagus nerve stimulation for chronic migraine prevention in a prospective, randomized, sham-controlled pilot study (the EVENT study): report from the double-blind phase. Late breaking poster 19. 56th Annual Scientific Meeting of the American Headache Society, Los Angeles, CA; 2014.
  • [49]Silberstein SD, Neves da Silva A, Calhoun AH, Grosberg BM, Lipton RB, Cady RK et al.. Chronic migraine prevention with non-invasive vagus nerve stimulation in a prospective pilot study (the EVENT study): report from the open-label phase. Late breaking poster 21. 56th Annual Scientific Meeting of the American Headache Society, Los Angeles, CA; 2014.
  • [50]Nesbitt AD, Marin JC, Tompkins E, Ruttledge MH, Goadsby PJ. Initial use of a novel noninvasive vagus nerve stimulator for cluster headache treatment. Neurology. 2015; 84:1249-53.
  • [51]Gaul C, Diener HC, Silver N, Magis D, Reuter U, Andersson A, et al. Non-invasive vagus nerve stimulation for PREVention and Acute treatment of chronic cluster headache (PREVA): a randomised controlled study. Cephalalgia. 2015. [Epub ahead of print].
  • [52]Schoenen J, Jensen RH, Lantéri-Minet M, Láinez MJ, Gaul C, Goodman AM et al.. Stimulation of the sphenopalatine ganglion (SPG) for cluster headache treatment. Pathway CH-1: a randomized, sham-controlled study. Cephalalgia. 2013; 33:816-30.
  • [53]Misra UK, Kalita J, Bhoi SK. High-rate repetitive transcranial magnetic stimulation in migraine prophylaxis: a randomized, placebo-controlled study. J Neurol. 2013; 260:2793-801.
  文献评价指标  
  下载次数:17次 浏览次数:18次