Tom 17, Nr 1 (2021)
Artykuł przeglądowy
Opublikowany online: 2021-03-30
Wyświetlenia strony
1954
Wyświetlenia/pobrania artykułu
640
Migrena — współczesne metody leczenia, przyszłe terapie
DOI: 10.5603/PPN.2021.0003
Pol. Przegl. Neurol 2021;17(1):19-35.
Streszczenie
Migrena jest uwar unkowanym genetycznie pier wotnym bólem głowy, który przebiega z epizodycznymi napadami, między którymi u chorych występuje stała gotowość do ich rozwinięcia. Wieloczynnikowa i złożona etiopatogeneza tej choroby znacznie utrudnia skuteczne leczenie. Autorzy na podstawie najnowszych doniesień i pr zeglądu badań klinicznych pr zedstawili aktualny stan wiedzy dotyczący leczenia doraźnego i profilaktycznego migreny. W ar tykule omówiono także pr zyszłe terapie, z któr ymi są wiązane duże nadzieje i które być może w niedalekiej przyszłości poszerzą możliwości skutecznego leczenia migreny.
Słowa kluczowe: migrenaprzeciwciała monoklonalneCGRPtoksyna botulinowagepantyditany
Referencje
- Dodick DW. Migraine. The Lancet. 2018; 391(10127): 1315–1330.
- Brola W, Sobolewski P. Nowe strategie leczenia i profilaktyki migreny. Aktual Neurol. 2019; 19(3): 132–140.
- Społeczne znaczenie migreny z perspektywy zdrowia publicznego i ochrony zdrowia. Narodowy Instytut Zdrowia Publicznego — Państwowy Zakład Higieny, Warszawa 2019. https://www.pzh.gov.pl/wp-content/uploads/2019/06/RAPORT-MIGRENA-ca%C5%82y.pdf (March 1, 2021).
- Lipton RB, Munjal S, Alam A, et al. Migraine in America Symptoms and Treatment (MAST) Study: Baseline Study Methods, Treatment Patterns, and Gender Differences. Headache. 2018; 58(9): 1408–1426.
- Stępień A. Modern migraine treatment. Ból. 2019; 20(1): 39–44.
- Ashina M. Migraine. N Engl J Med. 2020; 383(19): 1866–1876.
- Digre KB. What's new in the treatment of migraine? J Neuroophthalmol. 2019; 39(3): 352–359.
- Dodick DW. CGRP ligand and receptor monoclonal antibodies for migraine prevention: evidence review and clinical implications. Cephalalgia. 2019; 39(3): 445–458.
- Wrobel Goldberg S, Silberstein SD, Wrobel Goldberg S, et al. Targeting CGRP: a new era for migraine treatment. CNS Drugs. 2015; 29(6): 443–452.
- Domitrz I, Kozubski W. Rekomendacje diagnostyczno-terapeutyczne postępowania w migrenie. Pol Przegl Neurol. 2019; 15(B): 1–18.
- Thorlund K, Toor K, Wu P, et al. Comparative tolerability of treatments for acute migraine: a network meta-analysis. Cephalalgia. 2017; 37(10): 965–978.
- Hutchinson S, Lipton R, Ailani J, et al. Characterization of acute prescription migraine medication use. Mayo Clinic Proc. 2020; 95(4): 709–718.
- Loder EW, Rayhill M, Burch RC. Safety problems with a transdermal patch for migraine: lessons from the development, approval, and marketing process. Headache. 2018; 58(10): 1639–1657.
- Tepper SJ, Dodick DW, Schmidt PC, et al. Efficacy of ADAM zolmitriptan for the acute treatment of difficult-to-treat migraine headaches. Headache. 2019; 59(4): 509–517.
- Tepper SJ, Johnstone MR. Breath-powered sumatriptan dry nasal powder: an intranasal medication delivery system for acute treatment of migraine. Med Devices (Auckl). 2018; 11: 147–156.
- Shrewsbury SB, Jeleva M, Satterly KH, et al. STOP 101: a phase 1, randomized, open-label, comparative bioavailability study of INP104, dihydroergotamine mesylate (DHE) administered intranasally by a I123 precision olfactory delivery (POD®) device, in healthy adult subjects. Headache. 2019; 59(3): 394–409.
- Roberto G, Raschi E, Piccinni C, et al. Adverse cardiovascular events associated with triptans and ergotamines for treatment of migraine: systematic review of observational studies. Cephalalgia. 2015; 35(2): 118–131.
- Orlova Y, Rizzoli P, Loder E. Association of coprescription of triptan antimigraine drugs and selective serotonin reuptake inhibitor or selective norepinephrine reuptake inhibitor antidepressants with serotonin syndrome. JAMA Neurol. 2018; 75(5): 566–572.
- Spielmann K, Kayser A, Beck E, et al. Pregnancy outcome after anti-migraine triptan use: a prospective observational cohort study. Cephalalgia. 2018; 38(6): 1081–1092.
- Lipton RB, Buse DC, Fanning KM, et al. Cardiovascular contraindications to triptans in the migraine population: results from the American Migraine Prevalence and Prevention (AMPP) Study. Cephalalgia. 2013; 33(Suppl 8): 17–18.
- 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.
- Rubio-Beltrán E, Labastida-Ramírez A, Haanes KA, et al. Characterization of binding, functional activity, and contractile responses of the selective 5-HT receptor agonist lasmiditan. Br J Pharmacol. 2019; 176(24): 4681–4695.
- Vila-Pueyo M, Strother IC, Page K, et al. Lasmiditan inhibits trigeminovascular nociceptive transmission. Cephalalgia. 2016; 36(Suppl 1): 152–153.
- Kuca B, Silberstein SD, Wietecha L, et al. COL MIG-301 Study Group. Lasmiditan is an effective acute treatment for migraine: a phase 3 randomized study. Neurology. 2018; 91(24): e2222–e2232.
- 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.
- Kopka M. Lasmiditan w leczeniu napadów migreny. Aktual Neurol. 2019; 19(4): 179–182.
- 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.
- Tepper SJ, Krege JH, Lombard L, et al. Characterization of dizziness after lasmiditan usage: findings from the SAMURAI and SPARTAN acute migraine treatment randomized trials. Headache. 2019; 59(7): 1052–1062.
- 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.
- 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.
- Knievel K, Buchanan AS, Lombard L, et al. Lasmiditan for the acute treatment of migraine: subgroup analyses by prior response to triptans. Cephalalgia. 2020; 40(1): 19–27.
- 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. 2019; 20(1): 90.
- Negro A, Martelletti P, Negro A, et al. CGRP receptor antagonists: an expanding drug class for acute migraine? Expert Opin Investig Drugs. 2012; 21(6): 807–818.
- Croop R, Lipton RB, Kudrow D, et al. Rimegepant, an oral calcitonin gene-related peptide receptor antagonist, for migraine. N Engl J Med. 2019; 381(2): 142–149.
- 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.
- Dodick DW, Lipton RB, Ailani J, et al. Ubrogepant for the treatment of migraine. N Engl J Med. 2019; 381: 2230–41.
- 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.
- 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; 19(9): 727–737.
- 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.
- Stubberud A, Flaaen NM, McCrory DC, et al. Flunarizine as prophylaxis for episodic migraine: a systematic review with meta-analysis. Pain. 2019; 160(4): 762–772.
- Kopka M. Przeciwciała monoklonalne przeciw CGRP w leczeniu prewencyjnym migreny. Farmakoter Psychiatr Neurol. 2018; 34(3): 221–229.
- Goadsby PJ, Reuter U, Hallström Y, et al. controlled trial of erenumab for episodic migraine. N Engl J Med. 2017; 377(22): 2123–2132.
- Tepper SJ, Diener HC, Ashina M, et al. Erenumab in chronic migraine with medication overuse: subgroup analysis of a randomized trial. Neurology. 2019; 92(20): e2309–e2320.
- Do TP, Guo S, Ashina M. Therapeutic novelties in migraine: new drugs, new hope? J Headache Pain. 2019; 20(1): 37.
- Fiedler-Kelly J, Passarell J, Ludwig E, et al. Effect of fremanezumab monthly and quarterly doses on efficacy responses. Headache. 2020; 60(7): 1376–1391.
- Dodick DW, Ashina M, Brandes JL, et al. ARISE: a phase 3 randomized trial of erenumab for episodic migraine. Cephalalgia. 2018; 38(6): 1026–1037.
- Dodick DW, Silberstein SD, Bigal ME, et al. Effect of fremanezumab compared with placebo for prevention of episodic migraine: a randomized clinical trial. JAMA. 2018; 319(19): 1999–2008.
- Silberstein SD, Dodick DW, Bigal ME, et al. Fremanezumab for the preventive treatment of chronic migraine. N Engl J Med. 2017; 377(22): 2113–2122.
- Stauffer VL, Dodick DW, Zhang Qi, et al. Evaluation of galcanezumab for the prevention of episodic migraine: the EVOLVE-1 randomized clinical trial. JAMA Neurol. 2018; 75(9): 1080–1088.
- Skljarevski V, Matharu M, Millen BA, et al. Efficacy and safety of galcanezumab for the prevention of episodic migraine: results of the EVOLVE-2 Phase 3 randomized controlled clinical trial. Cephalalgia. 2018; 38(8): 1442–1454.
- Detke HC, Wang S, Skljarevski V et al. A phase 3 placebo-controlled study of galcanezumab in patients with chronic migraine: results from the 3-month double-blind treatment phase of the REGAIN study. 59th Annual Scientific Meeting American Headache Society. Boston, June 8–11, 2017.
- Saper J, Lipton R, Kudrow D, et al. Primary results of PROMISE-1 (Prevention Of Migraine via Intravenous eptinezumab Safety and Efficacy-1) trial: a phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of eptinezumab for prevention of frequent episodic migraines. American Academy of Neurology (AAN) Annual Meeting. Philadelphia, 21–27 April 2018.
- Lipton R, Saper J, Ashina M, et al. Randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of eptinezumab for the preventive treatment of chronic migraine: results of the PROMISE-2 (PRevention Of Migraine via Intravenous eptinezumab Safety and Efficacy-2) trial. American Academy of Neurology (AAN) Annual Meeting. Philadelphia, 21–27 April 2018.
- Ashina M, Dodick D, Goadsby PJ, et al. Erenumab (AMG 334) in episodic migraine: Interim analysis of an ongoing open-label study. Neurology. 2017; 89(12): 1237–1243.
- Dodick D, Goadsby P, Silberstein S, et al. Safety and efficacy of ALD403, an antibody to calcitonin gene-related peptide, for the prevention of frequent episodic migraine: a randomised, double-blind, placebo-controlled, exploratory phase 2 trial. Lancet Neurol. 2014; 13(11): 1100–1107.
- Dodick DW, Goadsby PJ, Spierings ELH, et al. Safety and efficacy of LY2951742, a monoclonal antibody to calcitonin gene-related peptide, for the prevention of migraine: a phase 2, randomised, double-blind, placebo-controlled study. Lancet Neurol. 2014; 13(9): 885–892.
- Walter S, Bigal ME. TEV-48125: a review of a monoclonal CGRP antibody in development for the preventive treatment of migraine. Curr Pain Headache Rep. 2015; 19(3): 6.
- Sacco S, Bendtsen L, Ashina M, et al. European headache federation guideline on the use of monoclonal antibodies acting on the calcitonin gene related peptide or its receptor for migraine prevention. J Headache Pain. 2019; 20(1): 6.
- American Headache Society. The American Headache Society position statement on integrating new migraine treatments into clinical practice. Headache. 2019; 59(1): 1–18.
- Ferrari MD, Diener HC, Ning X, et al. Fremanezumab versus placebo for migraine prevention in patients with documented failure to up to four migraine preventive medication classes (FOCUS): a randomised, double-blind, placebo-controlled, phase 3b trial. Lancet. 2019; 394(10203): 1030–1040.
- Brandes J, et al. Early efficacy of fremanezumab in episodic and chronic migraine in oatients who had "failed" preventive medication: lack of previous efficacy based on therapeutic class prior to the international, multicenter phase 3b FOCUS study postersession 1 P21. 14th European Headache Federation Congress. Berlin, 29.06-02.07.2020.
- Reuter U, Goadsby PJ, Lanteri-Minet M, et al. Efficacy and tolerability of erenumab in patients with episodic migraine in whom two-to-four previous preventive treatments were unsuccessful: a randomised, double-blind, placebo-controlled, phase 3b study. Lancet. 2018; 392(10161): 2280–2287.
- Silberstein SD, Cohen JM, Seminerio MJ, et al. 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.
- Ashina M, Goadsby PJ, Reuter U, et al. Long-term safety and tolerability of erenumab: three-plus year results from a five-year open-label extension study in episodic migraine. Cephalalgia. 2019; 39(11): 1455–1464.
- Ashina M, Goadsby P, Reuter U, et al. Sustained efficacy and long-term safety of erenumab in patients with episodic migraine: 4+ year results of a 5-year, open-label treatment period. Neurology. 1203; 94(15): Suppl–1203.
- Kudrow D, Pascual J, Winner PK, et al. Vascular safety of erenumab for migraine prevention. Neurology. 2020; 94(5): e497–e510.
- de Hoon J, Van Hecken A, Vandermeulen C, et al. Phase I, randomized, double-blind, placebo-controlled, single-dose, and multiple-dose studies of erenumab in healthy subjects and patients with migraine. Clin Pharmacol Ther. 2018; 103(5): 815–825.
- Depre C, Antalik L, Starling A, et al. A randomized, double-blind, placebo-controlled study to evaluate the effect of erenumab on exercise time during a treadmill test in patients with stable angina. Headache. 2018; 58(5): 715–723.
- Ornello R, Casalena A, Frattale I, et al. Real-life data on the efficacy and safety of erenumab in the Abruzzo region, central Italy. J Headache Pain. 2020; 21(1): 32.
- Kanaan S, Hettie G, Loder E, et al. Real-world effectiveness and tolerability of erenumab: a retrospective cohort study. Cephalalgia. 2020; 40(13): 1511–1522.
- Robblee J, Devick KL, Mendez N, et al. Real-world patient experience with erenumab for the preventive treatment of migraine. Headache. 2020; 60(9): 2014–2025.
- Raffaelli B, Kalantzis R, Mecklenburg J, et al. Erenumab in chronic migraine patients who previously failed five first-line oral prophylactics and onabotulinumtoxinA: a dual-center retrospective observational study. Front Neurol. 2020; 11: 417.
- Silberstein S, Tfelt-Hansen P, Dodick DW, et al. Task Force of the International Headache Society Clinical Trials Subcommittee. Guidelines for controlled trials of prophylactic treatment of chronic migraine in adults. Cephalalgia. 2008; 28(5): 484–495.
- Ziegeler C, May A. Non-responders to treatment with antibodies to the CGRP-receptor may profit from a switch of antibody class. Headache. 2020; 60(2): 469–470.
- Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018; 38(1): 1–211.
- Escher CM, Paracka L, Dressler D, et al. Botulinum toxin in the management of chronic migraine: clinical evidence and experience. Ther Adv Neurol Disord. 2017; 10(2): 127–135.
- Frampton JE. OnabotulinumtoxinA in chronic migraine: a profile of its use. CNS Drugs. 2020; 34(12): 1287–1298.
- Burstein R, Blumenfeld AM, Silberstein SD, et al. Mechanism of action of onabotulinumtoxinA in chronic migraine: a narrative review. Headache. 2020; 60(7): 1259–1272.
- Aurora SK, Dodick DW, Turkel CC, et al. PREEMPT 1 Chronic Migraine Study Group. OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 1 trial. Cephalalgia. 2010; 30(7): 793–803.
- Diener HC, Dodick DW, Aurora SK, et al. PREEMPT 2 Chronic Migraine Study Group. OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 2 trial. Cephalalgia. 2010; 30(7): 804–814.
- Silberstein SD, Dodick DW, Aurora SK, et al. Per cent of patients with chronic migraine who responded per onabotulinumtoxinA treatment cycle: PREEMPT. J Neurol Neurosurg Psychiatry. 2015; 86(9): 996–1001.
- Winner PK, Blumenfeld AM, Eross EJ, et al. Long-term safety and tolerability of onabotulinumtoxinA treatment in patients withchronic migraine: results of the COMPEL study. Drug Saf. 2019; 42(8): 1013–1024.
- Ahmed F, Gaul C, García-Moncó JC, et al. REPOSE Principal Investigators. An open-label prospective study of the real-life use of onabotulinumtoxinA for the treatment of chronic migraine: the REPOSE study. J Headache Pain. 2019; 20(1): 26.
- Ornello R, Guerzoni S, Baraldi C, et al. Sustained response to onabotulinumtoxin A in patients with chronic migraine: real-life data. J Headache Pain. 2020; 21(1): 40.
- Blumenfeld A, Silberstein SD, Dodick DW, et al. Method of injection of onabotulinumtoxinA for chronic migraine: a safe, well-tolerated, and effective treatment paradigm based on the PREEMPT clinical program. Headache. 2010; 50(9): 1406–1418.
- Charakterystyka produktu leczniczego Botox. https://meden.com.pl/upload/PL-SPC-Botox_100U-NAT-PL-2014.06.11.pdf (March 1, 2021).
- Eren OE, Gaul C, Peikert A, et al. Triptan efficacy does not predict onabotulinumtoxinA efficacy but improves with onabotulinumtoxinA response in chronic migraine patients. Sci Rep. 2020; 10(1): 11382.
- Blumenfeld AM, Tepper SJ, Robbins LD, et al. Effects of onabotulinumtoxinA treatment for chronic migraine on common comorbidities including depression and anxiety. J Neurol Neurosurg Psychiatry. 2019; 90(3): 353–360.
- Hansson-Hedblom A, Axelsson I, Jacobson L, et al. Economic consequences of migraine in Sweden and implications for the cost-effectiveness of onabotulinumtoxinA (Botox) for chronic migraine in Sweden and Norway. J Headache Pain. 2020; 21(1): 99.
- Ching J, Tinsley A, Rothrock J. Prognosis following discontinuation of onabotulinumA therapy in "super-responding" chronic migraine patients. Headache. 2019; 59(8): 1279–1285.
- Dodick DW, Silberstein SD, Lipton RB, et al. Early onset of effect of onabotulinumtoxinA for chronic migraine treatment: Analysis of PREEMPT data. Cephalalgia. 2019; 39(8): 945–956.
- Young WB, Ivan Lopez J, Rothrock JF, et al. Effects of onabotulinumtoxinA treatment in chronic migraine patients with and without daily headache at baseline: results from the COMPEL Study. J Headache Pain. 2019; 20(1): 12.
- Rothrock JF, Adams AM, Lipton RB, et al. FORWARD Study Investigative Group. FORWARD study: evaluating the comparative effectiveness of onabotulinumtoxinA and topiramate for headache prevention in adults with chronic migraine. Headache. 2019; 59(10): 1700–1713.
- Matharu M, Pascual J, Nilsson Remahl I, et al. Utilization and safety of onabotulinumtoxinA for the prophylactic treatment of chronic migraine from an observational study in Europe. Cephalalgia. 2017; 37(14): 1384–1397.
- Bendtsen L, Sacco S, Ashina M, et al. Guideline on the use of onabotulinumtoxinA in chronic migraine: a consensus statement from the European Headache Federation. J Headache Pain. 2018; 19(1): 91.
- Gomez-Mancilla B, Brand R, Jürgens TP, et al. BGG492 Study Group. Randomized, multicenter trial to assess the efficacy, safety and tolerability of a single dose of a novel AMPA receptor antagonist BGG492 for the treatment of acute migraine attacks. Cephalalgia. 2014; 34(2): 103–113.
- Marin JCA, Goadsby PJ. Glutamatergic fine tuning with ADX-10059: a novel therapeutic approach for migraine? Expert Opin Investig Drugs. 2010; 19(4): 555–561.
- Sang CN, Ramadan NM, Wallihan RG, et al. LY293558, a novel AMPA/GluR5 antagonist, is efficacious and well-tolerated in acute migraine. Cephalalgia. 2004; 24(7): 596–602.
- Alstadhaug KB, Odeh F, Salvesen R, et al. Prophylaxis of migraine with melatonin: a randomized controlled trial. Neurology. 2010; 75(17): 1527–1532.
- Ashina M, Doležil D, Bonner JoH, et al. A phase 2, randomized, double-blind, placebo-controlled trial of AMG 301, a pituitary adenylate cyclase-activating polypeptide PAC1 receptor monoclonal antibody for migraine prevention. Cephalalgia. 2021; 41(1): 33–44.
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