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Качественная клиническая практика

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Инновационные лекарственные препараты для терапии первичных головных болей: мигрень

https://doi.org/10.24411/2588-0519-2019-10077

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Аннотация

В статье изложена информация о современных препаратах для лечения первичных головных болей (в частности мигрени), которые находятся на стадиях клинических или доклинических исследований, или были недавно выведены на зарубежный фармацевтический рынок. Представлены классы данных препаратов, их механизм действия, а также результаты прошедших исследований.

Об авторах

О. В. Решетько
ФГБОУ ВО «Саратовский государственный медицинский университет им. В.И. Разумовского» Минздрава России
Россия

Решетько Ольга Вилоровна Автор – доктор медицинских наук профессор, заведующий кафедрой фармакологии

SPIN-код: 7569-7915



А. И. Гришин
ФГБОУ ВО «Саратовский государственный медицинский университет им. В.И. Разумовского» Минздрава России
Россия

Гришин Антон Игоревич - аспирант кафедры фармакологии



Список литературы

1. who.int [интернет]. Всемирная Организация Здравоохранения. Информационный бюллетень Всемирной Организации Здравоохранения “Головные боли”, 2016 [доступ от 7.05.2019]. Доступ по ссылке https://www.who.int/ru/news-room/fact-sheets/detail/headache-disorders

2. Сидоренко И. Новые подходы к лечению головной боли напряжения // ReUpoNews. — 2013. — Т.2. — №6 — С. 66—68.

3. International Headache Society 2018. Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. 2018;38(1):1-211. DOI: 10.1177/0333102417738202

4. Осипова В.В. Первичные головные боли: клиника, диагностика, терапия. Информационное письмо (для неврологов, терапевтов, врачей общей практики). — Ростов-на-Дону.: Издательство Антей. — 2011. — 51 с.

5. Осипова В.В. Первичные головные боли: диагностика и лечение. Методические рекомендации. URL: https://clck.ru/Jcagx

6. Кое-что еще о мигрени // Наука и жизнь. — 2001. — №12.

7. Садоха К.А., Головко Т.Г. Роль серотонина в патогенезе и лечении мигрени. Медицинские новости. — 2005. — №4. — С. 40-43.

8. Agosti RM. 5-HT1F- and 5-HT7-receptor agonists for the treatment of migraines. NS & Neurological Disorders — Drug Targets. 2007;6(4):235-237.

9. Phebus LA, Ramadan NM, Skljarevski V, et al. 5-HT1F receptor agonists in acute migraine treatment: a hypothesis. Cephalalgia. 2003;23(8):776-785.

10. Азимова Ю.Э., Рачин А.П., Ищенко К.А., и др. Инновационные методы лечения мигрени // Российский медицинский журнал. — 2015. — Т. 23. — №30. — С. 27-30.

11. Дубенко О.Е. Кальцитонин-ген-связанный пептидпри мигрени: патогенетический фактор и терапевтическая мишень (обзор) // Международный неврологический журнал. — 2018. — Т.96. — №2. — С.38-44. DOI: 10.22141/2224-0713.2.96.2018.130481

12. Gomez-Mancilla B, Cutler NR, Leibowitz MT. Safety and Efficacy of PNU-142633, a Selective 5-HT1D Agonist, in Patients with Acute Migraine. Cefalgia. 2001;21(7):727-732. DOI: 10.1111/j.1468-2982.2001.00208.x

13. Brenchat A, et al. Role of peripheral versus spinal 5-HT(7) receptors in the modulation of pain undersensitizing conditions. European Journal of pain. 2012;16(1):72-81. DOI: 10.1016/j.ejpain.2011.07.004

14. Goldstein DJ, Roon KI, Offen WW, et al. Selective serotonin 1F (5-HT(1F)) receptor agonist LY334370 for acute migraine: a randomised controlled trial. Lancet. 2001;358(9289): 1230-1234. DOI: 10.1016/s0140-6736(01)06347-4

15. clinicaltrials.gov [Internet]. A Placebo-Controlled Adaptive Treatment Assignment Study of Intravenous COL-144 in the Acute Treatment of Migraine [cited 2019 May 7]. Available from https://clinicaltrials.gov/ct2/show/NCT00384774

16. clinicaltrials.gov [Internet]. Dose-ranging Study of Oral COL-144 in Acute Migraine Treatment [cited 2019 May 7]. Available from https://www.clinicaltrials.gov/ct2/show/NCT00883051

17. Ferrari MD, Frkkil M, Reuter U, et al. Acute treatment of migraine with the selective 5-HT1F receptor agonist lasmiditan — a randomised proof-of-concept trial. Cephalalgia. 2010;30(10):1170-1178. DOI: 10.1177/0333102410375512

18. Farkkila M, Diener HC, Geraud G, et al. Efficacy and tolerability of lasmiditan, an oral 5-HT(1F) receptor agonist, for the acute treatment of migraine: a phase 2 randomised, placebo-controlled, parallel-group, doseranging study. Lancet Neurology. 2012;11(5):405-413. DOI: 10.1016/S1474-4422(12)70047-9

19. clinicaltrials.gov [Internet]. Three Doses of Lasmiditan (50 mg, 100 mg and 200 mg) Compared to Placebo in the Acute Treatment of Migraine (SPARTAN) [cited 2019 May 7]. Available from https://www.clinicaltrials.gov/ct2/show/NCT02605174

20. clinicaltrials.gov [Internet]. An Open-label, Long-term, Safety Study of Lasmiditan for the Acute Treatment of Migraine (GLADIATOR) [cited 2019 May 7]. Available from https://www.clinicaltrials.gov/ct2/show/NCT02565186

21. FierceBiotech [Internet]. Eli Lilly files for FDA approval of migraine drug lasmiditan [cited 2019 May 7]. Available from https://www.fiercebiotech.com/biotech/lilly-files-for-fda-approval-migraine-drug-lasmiditan

22. Health Central [Internet]. New GCRP Migraine Treatments in Development — March, 2016, Report [cited 2019 May 7]. Available from https://www.healthcentral.com/article/new-gcrp-migraine-treatments-in-development-march-2016-report

23. Gang Yao, Tingmin Yu, Ximei Han, et al. Therapeutic effects and safety of olcegepant and telcagepant for migraine: A meta-analysis. Neural Regen Res. 2013;8(10):938-947. DOI: 10.3969/j.issn.1673-5374.2013.10.009

24. Ho TW, Mannix LK, Assaid C, et al. Randomized controlled trial of an oral CGRP receptor antagonist, MK-0974, in acute treatment of migraine. Neurology. 2008;70(16):1304-1312. DOI: 10.1212/01.WNL.0000286940.29755.61

25. clinicaltrials.gov [Internet]. MK0974 (Telcagepant) for Migraine Prophylaxis in Patients With Episodic Migraine (0974-049) [cited 2019 May 7]. Available from https://www.clinicaltrials.gov/ct2/show/NCT00797667

26. clinicaltrials.gov [Internet]. Trial in Adult Subjects With Acute Migraines [cited 2019 May 7]. Available from https://clinicaltrials.gov/ct2/show/NCT03461757

27. MPR [Internet]. Rimegepant Zydis ODT Beneficial in Phase 3 Migraine Trial [cited 2019 May 7]. Available from https://www.empr.com/home/news/drugs-in-the-pipeline/rimegepant-zydis-odt-beneficial-in-phase-3-migraine-trial/

28. clinicaltrials.gov [Internet]. Efficacy and Safety Trial of Rimegepant for Migraine Prevention in Adults [cited 2019 May 7]. Available from https://clinicaltrials.gov/ct2/show/NCT03732638

29. Drugs.com [Internet]. Biohaven Announces Completion of Pre-NDA Meeting With FDA for Oral CGRP Receptor Antagonist Rimegepant [cited 2019 May 7]. Available from https://www.drugs.com/clinical_trials/biohaven-announces-completion-pre-nda-meeting-fda-oral-cgrp-receptor-antagonist-rimegepant-18098.html

30. Allergan [Internet]. Allergan Announces FDA Acceptance of New Drug Application for Ubrogepant for the Acute Treatment of Migraine [cited 2019 May 7]. Available from https://www.allergan.com/news/news/thomson-reuters/allergan-announces-fda-acceptance-of-new-drug-appl

31. clinicaltrials.gov [Internet]. Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine (ACHIEVE II) [cited 2019 May 7]. Available from https://clinicaltrials.gov/ct2/show/NCT02867709

32. clinicaltrials.gov [Internet]. Efficacy, Safety, and Tolerability Study of Oral Ubrogepant in the Acute Treatment of Migraine (ACHIEVE I) [cited 2019 May 7]. Available from https://clinicaltrials.gov/ct2/show/NCT02828020

33. clinicaltrials.gov [Internet]. An Extension Study to Evaluate the LongTerm Safety and Tolerability of Ubrogepant in the Treatment of Migraine [cited 2019 May 7]. Available from https://clinicaltrials.gov/ct2/show/NCT02873221

34. Xu C, Shi L, Rao S, et al. EHMTI-0315. AMG 334, the first potent and selective human monoclonal antibody antagonist against the CGRP. The Journal of Headache and Pain. 2014 Sep;54(Suppl. 1):1417-1418. DOI: 10.1186/1129-2377-15-S1-G43

35. Pharma World Magazine [Internet]. Erenumab to prevent migraine: results from phase III STRIBE [cited 2019 May 7]. Available from http://www.pharmaworldmagazine.com/erenumab-prevent-migraine-results-phase-iii-stribe/

36. Novartis presents data demonstrating efficacy of AMG 334 (erenumab) in migraine prevention at the American Headache Society Annual Meeting [Internet]. [cited 2019 May 7] Available from: https://www.novartis.com/news/media-releases/novartis-presents-data-demonstrating-efficacy-amg-334-erenumab-migraine

37. fda.gov [Internet]. FDA approves novel preventive treatment for migraine [cited 2019 May 7]. Available from: https://www.fda.gov/news-events/press-announcements/fda-approves-novel-preventive-treatment-migraine

38. TheGuardian.com [Internet]. First drug to prevent chronic migraines approved by EU [cited 2019 May 7]. Available from: https://www.theguardian.com/science/2018/jul/31/first-ever-pill-to-prevent-chronic-migraines-approved-by-eu

39. Novartis [Internet]. Novartis receives positive CHMP opinion for Aimovig® (erenumab) for the prevention of migraine [cite 2019 May 7]. Available from https://www.novartis.com/news/media-releases/novartis-receives-positive-chmp-opinion-aimovigr-erenumab-prevention-migraine

40. Drugs.com [Internet]. Aimovig Approval History [cited 2019 May 7]. Available from https://www.drugs.com/history/aimovig.html

41. biospace.com [Internet]. Pfizer Inc. To Acquire Rinat Neuroscience Corporation [cited 2019 May 7]. Available from https://www.biospace.com/article/releases/pfizer-inc-to-acquire-rinat-neuroscience-corporation-/

42. Dodick DW, Silberstein SD, Bigal ME, et al. Effect of Fremanezumab Compared With Placebo for Prevention of Episodic Migraine: A Randomized Clinical Trial. Journal of the American Medical Association. 2018 May;319(19):1999-2008. DOI: 10.1001/jama.2018.4853

43. Silberstein SD, McAllister P, Ning X, et al. Safety and Tolerability of Fremanezumab for the Prevention of Migraine: A Pooled Analysis of Phases 2b and 3 Clinicaltrials.gov. Headache: The journal of Head and Face Pain. 2019;59(6):880-890. DOI:10.1111/head.13534

44. Medscape [Internet]. FDA Approves Fremanezumab (Ajovy) for Migraine Prevention [cited 2019 May 7]. Available from https://www.medscape.com/viewarticle/902071

45. PMLive.com [Internet]. Teva’s migraine injection approved in Europe [cited 2019 May 7]. Available from https://www.pmlive.com/pharma_news/tevas_migraine_injection_approved_in_europe_1283616

46. businesswire.com [Internet] Teva’s AJOVY® Receives EU Approval Offering Patients the First and Only Anti-CGRP Treatment with Both Quarterly and Monthly Dosing for the Prophylaxis of Migraine in Adults [cited 2019 May 7]. Available from https://www.businesswire.com/news/home/20190401005452/en/

47. Drugs.com [Internet]. Fremanezumab [cited 2019 May 7]. Available from https://www.drugs.com/mtm/fremanezumab.html

48. clinicaltrials.gov [Internet]. Evaluation of Galcanezumab in the Prevention of Episodic Migraine- the EVOLVE-1 Study (EVOLVE-1) [cited 2019 May 7]. Available from https://clinicaltrials.gov/ct2/show/NCT02614183

49. clinicaltrials.gov [Internet]. Evaluation of Efficay & Safety of Galcanezumab in the Prevention of Episodic Migraine- the EVOLVE-2 Study (EVOLVE-2) [cited 2019 May 7]. Available from https://clinicaltrials.gov/ct2/show/NCT02614196

50. clinicaltrials.gov [Internet] Evaluation of Galcanezumab in the Prevention of Chronic Migraine (REGAIN). [cited 2019 May 7]. Available from https://clinicaltrials.gov/ct2/show/NCT02614261

51. CNBC [Internet]. US FDA approves Lilly migraine drug at a price that is the same as its rivals [cited 019 May 7]. Available from https://www.cnbc.com/2018/09/28/us-fda-approves-lilly-migraine-drug-at-a-price-that-is-the-same-as-its-rivals.html

52. Фармацевтический вестник [интернет]. Еврокомиссия одобрила Emgality для профилактики мигрени [доступ от 7.05.2019]. Доступно по ссылке https://pharmvestnik.ru/content/news/Evrokomissiya-odobrila-Emgality-dlya-profilaktiki-migreni.html

53. Drugs.com [Internet]. Galcanezumab [cited 2019 May 7]. Available from https://www.drugs.com/mtm/galcanezumab.html

54. grls.rosminzdrav.ru [интернет]. Государственный реестр лекарственных средств. Оценка эффективности и безопасности галканезумаба у пациентов с эпизодической мигренью [доступ от 7.05.2019]. Доступ по ссылке http://grls.rosminzdrav.ru/CIPermissionMini.aspx?CIStatementGUID=f2bb0510-0db1-4661-ba61-f26f0a1e42f0&CIPermGUID=B76D68CF-AB7B-4FD9-95E8-7A9B4F453F7B

55. Alder BioPharmaceuticals, Inc [Internet]. Alder Announces Eptinezumab Significantly Reduces Migraine Risk Meets Primary and All Key Secondary Endpoints in Pivotal PROMISE 2 Phase 3 Trial for Chronic Migraine Prevention [cited 2019 May 7]. Available from https://investor.alderbio.com/news-releases/news-release-details/alder-announces-eptinezumab-significantly-reduces-migraine-risk

56. Российская Фармацевтика [интернет]. FDA одобрило препарат для лечения эпизодической кластерной головной боли [доступ от 5.06.2019] . Доступ по ссылке http://pharmapractice.ru/156333

57. ГК Ремедиум [интернет]. Alder успешно испытала новый препарат для лечения мигрени [доступ от 7.05.2019]. Доступ по ссылке http://remedium.ru/news/detail.php?ID=73186 7.05.2019] . Dostup po ssylke http://remedium.ru/news/detail.php?ID=73186 (In Russ).]

58. Alder BioPharmaceuticals, Inc [Internet]. Eptinezumab [cited 2019 may 2017]. Available from https://investor.alderbio.com/news-releases/ news-release-details/alder-announces-eptinezumab-significantly-reduces-migraine-riskhttps://www.alderbio.com/pipeline/eptinezumab/

59. Rubio-Beltran E, Correnti E, Deen M, et al. PACAP38 and PAC1 receptor blockade: a new target for headache? J Headache Pain. 2018;19(1). DOI:10.1186/s10194-018-0893-8

60. Moldovan Loomis C, Dutzar B, Ojala E, et al. Pharmacologic Characterization of ALD1910, a Potent Humanized Monoclonal Antibody against the Pituitary Adenylate Cyclase-Activating Peptide. Journal of Pharmacology and Experimental Therapeutics. 2019;369(1):26-36. DOI:10.1124/jpet.118.253443

61. Alder BioPharmaceuticals, Inc [Internet]. Alder BioPharmaceuticals Reports First Quarter 2019 Financial and Operating Results [cited 2019 May 7]. Available from https://investor.alderbio.com/news-releases/news-release-details/alder-biopharmaceuticalsr-reports-first-quarter-2019-financial

62. clinicaltrials.gov [Internet]. Study to Evaluate the Efficacy and Safety of AMG 301 in Migraine Prevention [cited 2019 May 7]. [Available from https://clinicaltrials.gov/ct2/show/NCT03238781

63. Gratton S, Cossack M. Answering the Call: A Prospective Look at the Role of Timolol Eye Drops in the Treatment of Acute Migraine. Missouri Medicine. 2018;115(6):520-521.

64. clinicaltrials.gov [Internet]. A Randomized Study Evaluating the Efficacy and Safety of Timolol Ophthalmic Solution as an Acute Treatment of Migraine [cited 2019 May 7]. Available from https://clinicaltrials.gov/ct2/show/NCT03836664

65. Ionis [Internet]. Ionis Innovation: Our antisense-powered pipeline [cited 2019 May 7] // Available from https://www.ionispharma.com/ionis-innovation/pipeline/

66. clinicaltrials.gov [Internet]. Efficacy and Safety of IONIS-PKKRx for Preventive Treatment of Chronic Migraine [cited 2019 May 7]. Available from https://clinicaltrials.gov/ct2/show/NCT03108469

67. Tepper S, Dodick D, Schmidt P, Kellerman D. Efficacy of ADAM Zolmitriptan for the Acute Treatment of Difficult-to-Treat Migraine Headaches. Headache: The Journal of Head and Face Pain. 2019;59(4):509-517. DOI:10.1111/head.13482

68. clinicaltrials.gov [Internet]. A Study to Evaluate the Long-Term Safety of M207 in the Acute Treatment of Migraine (ADAM) [cited 2019 May 7]. Available from: https://clinicaltrials.gov/ct2/show/NCT03282227

69. ZosanoPharma [Internet]. Zosano Treats over 4,000 Migraines and Reaches an Important Goal in M207-ADAM Long-term Safety Study [cited 2019 May 7]. Available from http://ir.zosanopharma.com/news-releases/news-release-details/zosano-treats-over-4000-migraines-and-reaches-important-goal


Для цитирования:


Решетько О.В., Гришин А.И. Инновационные лекарственные препараты для терапии первичных головных болей: мигрень. Качественная клиническая практика. 2019;(2):95-104. https://doi.org/10.24411/2588-0519-2019-10077

For citation:


Reshetko O.V., Grishin A.I. Innovative drugs for the treatment of primary headaches: migraine. Kachestvennaya klinicheskaya praktika. 2019;(2):95-104. (In Russ.) https://doi.org/10.24411/2588-0519-2019-10077

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ISSN 2588-0519 (Print)
ISSN 2618-8473 (Online)