Efficacy and safety of the antileukotriene drugs: relevant data. RAACI experts conclusion

封面

如何引用文章

全文:

详细

In many countries of the world and in Russia, in particular, the pharmacological use of antagonists of cysteinyl receptors LT1 (CysLTR) is a long­-proven and well­-proven pharmacotherapy of bronchial asthma (BA) and allergic rhinitis (AR) in adults and children.

Among antileukotriene drugs the most commonly used medication for the treatment of these diseases is the original montelukast, which is considered a safe drug associated with the appearance of only a few adverse reactions, usually not differing in type and frequency from those that occur with placebo. Currently, there are a large number of generics of montelukast, therefore, practitioners have many questions regarding the benefits and risks of montelukast therapy for patients with BA and AR.

In 2020 FDA (Food and Drug Administration USA) analyzed the risk of adverse events during Montelukast treatment and indicated them on the packaging of the drug (original montelukast and its generics). This contributed to the creation of an expert commission to study this issue and form an expert opinion, which is demonstrated in our publication.

作者简介

Natalya Il`ina

NRC Institute of Immunology FMBA of Russia

Email: instimmun@yandex.ru
ORCID iD: 0000-0002-3556-969X

head physician, NRC Institute of Immunology FMBA of Russia, MD, PhD, DSc, professor

俄罗斯联邦, Moscow

Oksana Kurbacheva

NRC Institute of Immunology FMBA of Russia

编辑信件的主要联系方式.
Email: kurbacheva@gmail.com
ORCID iD: 0000-0003-3250-0694

head of the Department of Bronchial Asthma, NRC Institute of Immunology FMBA of Russia, MD, PhD, DSc, professor

俄罗斯联邦, Moscow

Natalya Nenasheva

Russian Medical Academy of Continuous Professional Education of the Ministry of Healthcare of Russian Federation

Email: 1444031@gmail.com
ORCID iD: 0000-0002-3162-2510

head of the Chair of Clinical Allergology, Russian Medical Academy of Continuous Professional Education of Ministry of Health of the Russian Federation, MD, PhD, DSc, professor

俄罗斯联邦, Moscow

Natalya Astafieva

Saratov State Medical University named after V.I. Razumovsky

Email: astang@mail.ru
ORCID iD: 0000-0002-7691-4584

head of the Chair of Clinical Immunology and Allergology, FSBE Institution of Higher Education «Saratov State Medical University named after V. I. Razumovsky» of Ministry of Health of the Russian Federation, MD, PhD, DSc, professor

俄罗斯联邦, Saratov

Evgenij Beltyukov

Ural State Medical University

Email: asthma@mail.ru
ORCID iD: 0000-0003-2485-2243

professor of the Department of Faculty Therapy, Endocrinology, Allergology and Immunology, FSBE Institution of Higher Education «Ural State Medical University» of Ministry of Health of the Russian Federation, chief freelance specialist allergist-immunologist of Ministry of Health of the Sverdlovsk Region and the Ural Federal District, MD, PhD, DSc, professor

俄罗斯联邦, Ekaterinburg

Irina Demko

Professor V.F. Voino-Yasenetsky Krasnoyarsk State Medical University

Email: demko64@mail.ru
ORCID iD: 0000-0001-8982-5292

professor of the Department of Internal Diseases, «Professor V.F. Voino-Yasenetsky Krasnoyarsk State Medical University» of Ministry of Health of the Russian Federation, chief physician-pulmonologist of the Siberian Federal District, chief allergist of the Siberian Federal District, chief pulmonologist and allergist of Ministry of Health of the Krasnoyarsk Region, MD, PhD, DSc, professor

俄罗斯联邦, Krasnoyarsk

Aleksandr Zhestkov

Samara State Medical University

Email: avzhestkov2015@yandex.ru
ORCID iD: 0000-0002-3960-830X

head of the Chair of General and Clinical Microbiology, Immunology and Allergology, FSBE Institution of Higher Education «Samara State Medical University» of Ministry of Health of the Russian Federation, chief freelance specialist in allergology and immunology of Ministry of Health of the Samara Region; chief pulmonologist of the Volga Federal District, MD, PhD, DSc, professor

俄罗斯联邦, Samara

Galina Osipova

Pulmonology Research Institute FMBA of Russia

Email: osipovagl@mail.ru

head of the Clinical Research Department, Pulmonology Research Institute under FMBA of Russia, MD, PhD, DSc

俄罗斯联邦, Moscow

参考

  1. Miligkos M, Bannuru RR, Alkofide H, Kher SR, Schmid CH, Balk EM. Leukotriene-receptor antagonists versus placebo in the treatment of asthma in adults and adolescents, a systematic review and meta-analysis. Ann Intern Med. 2015;163(10):756–767. doi: 10.7326/M15-1059
  2. Zhang HP, Jia CE, Lv Y, Gibson PG, Wang G. Montelukast for prevention and treatment of asthma exacerbations in adults: systematic review and meta-analysis. Allergy Asthma Proc. 2014;35(4):278–787. doi: 10.2500/aap.2014.35.3745
  3. spulmo.ru [Internet]. Federal’nye klinicheskie rekomendatsii po diagnostike i terapii bronkhial’noi astmy. Peresmotr 2019 g. [cited 2002 Sep 8]. Available from: https://spulmo.ru/upload/kr_bronhastma_2019.pdf (In Russ.).
  4. ginasthma.org [Internet]. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention (2020 update). GINA. 2020 [cited 2002 Sep 8]. Available from: https://ginasthma.org
  5. Nayak A, Langdon RB. Montelukast in the treatment of allergic rhinitis: an evidence-based review. Drugs. 2007;67(6):887–901. doi: 10.2165/00003495-200767060-00005
  6. Price DB, Swern A, Tozzi CA, Philip G, Polos P. Effect of montelukast on lung function in asthma patients with allergic rhinitis: analysis from the COMPACT trial. Allergy. 2006;61(6):737–742. doi: 10.1111/j.1398-9995.2006.01007.x
  7. Virchow JC, Mehta A, Ljungblad L, Mitfessel H. A subgroup analysis of the MONICA study: a 12-month, open-label study of add-on montelukast treatment in asthma patients. J Asthma. 2010;47(9):986–993. doi: 10.1080/02770903.2010.494753
  8. Nwokoro C, Pandya H, Turner S, Eldridge S, Griffiths CJ, Vulliamy T, et al. Intermittent montelukast in children aged 10 months to 5 years with wheeze (WAIT trial): a multicentre, randomised, placebo-controlled trial. Lancet Respir Med. 2014;2(10):796–803. doi: 10.1016/s2213-2600(14)70186-9
  9. Bisgaard H, Skoner D, Boza ML, Tozzi CA, Newcomb K, Reiss TF, et al. Safety and tolerability of montelukast in placebo-controlled pediatric studies and their open-label extensions. Pediatr Pulmonol. 2009;44(6):568–579. doi: 10.1002/ppul.21018
  10. Philip G, Hustad C, Noonan G, Malice MP, Ezekowitz A, Reiss TF, et al. Reports of suicidality in clinical trials of montelukast. J Allergy Clin Immunol. 2009;124(4):691–696.e6. doi: 10.1016/j.jaci.2009.08.010
  11. Philip G, Hustad C, Noonan G, Malice MP, Ezekowitz A, Reiss TF, et al. Analysis of behavior-related adverse experiences in clinical trials of Montelukast. J Allergy Clin Immunol. 2009;124(4):699–706.e8. doi: 10.1016/j.jaci.2009.08.011
  12. Bygdell M, Brunlof G, Wallerstedt SM, Kindblom JM. Psychiatric adverse drug reactions reported during a 10-year period in the Swedish pediatric population. Pharmacoepidemiol Drug Saf. 2012;21(1):79–86. doi: 10.1002/pds.2265
  13. Benard B, Bastien V, Vinet B, Yang R, Krajinovic M, Ducharme FM. Neuropsychiatric adverse drug reactions in children initiated on montelukast in real-life practice. Eur Respir J. 2017;50(2):1700148. doi: 10.1183/13993003.00148-2017
  14. Haarman MG, Hunsel FV, de Vries TW. Adverse drug reactions of montelukast in children and adults. Pharmacol Res Perspect. 2017;5(5):e00341. doi: 10.1002/prp2.341
  15. raaci.ru [Internet]. Proekt federal’nykh klinicheskikh rekomendatsii. Allergicheskii rinit. Peresmotr 2019 g. [cited 2002 Sep 8]. Available from: https://raaci.ru/education/clinic_recomendations/471.html (In Russ.).
  16. Brozek JL, Bousquet J, Agache I, Agarwal A, Bachert C, Bosnic-Anticevich S, et al. Allergic Rhinitis and its Impact on Asthma (ARIA) Guidelines – 2016 Revision. J Allergy Clin Immunol. 2017;140(4):950–958. doi: 10.1016/j.jaci.2017.03.050
  17. Dahlen S-E, Malmström K, Nizankowska E, Dahlen B, Kuna P, Kowalski M, et al. Improvement of aspirin-intolerant asthma by montelukast, a leukotriene antagonist: a randomized, double-blind, placebo-controlled trial. J Respir Crit Care Med. 2002;165(1):9–14. doi: 10.1164/ajrccm.165.1.2010080
  18. Pearlman DS, van Adelsberg J, Philip G, Tilles SA, Busse W, Hendeles L, et al. Onset and duration of protection against exercise-induced bronchoconstriction by a single oral dose of montelukast. Ann Allergy Immunol. 2006;97(1):98–104. doi: 10.1016/S1081-1206(10)61377-4
  19. Peroni DG, Pescollderungg L, Sandri M, Chinellato I, Boner AL, Piacentini GL. Time-effect of montelukast on protection against exercise-induced bronchoconstriction. Respir Med. 2011;105(12):1790–1797. doi: 10.1016/j.rmed.2011.08.007
  20. De Benedictis FM, Del Giudice MM, Forenza N, et al. Lack of tolerance to the protective effect of montelukast in exercise-induced bronchoconstriction in children. Eur Respir J. 2006;28(2):291–295. doi: 10.1183/09031936.06.00020606
  21. Peters-Golden M, Swern A, Bird S, et al. Influence of body mass index on the response to asthma controller agents. Eur Respir J. 2006;27(3):495–503. doi: 10.1183/09031936.06.00077205
  22. Sutherland ER, Camargo CA, Jr Busse WW, Meltzer EO, Ortega HG, Yancey SW, et al. Comparative effect of body mass index on response to asthma controller therapy. Allergy Asthma Proc. 2010;31(1):20–25. doi: 10.2500/aap.2010.31.3307
  23. Lazarus SC, Chinchilli VM, Rollings NJ, Boushey HA, Cherniack R, Craig TJ, et al. Smoking affects response to inhaled corticosteroids or leukotriene receptor antagonists in asthma. Am J Respir Crit Care Med. 2007;175(8):783–790. doi: 10.1164/rccm.200511-1746oc
  24. Price D, Popov T, Bjermer L, Lu S, Petrovic R, Vandormael K, et al. Effect of montelukast for treatment of asthma in cigarette smokers. J Allergy Clin Immunol. 2013;131(3):763–771. doi: 10.1016/j.jaci.2012.12.673
  25. fda.gov [Internet]. FDA requires Boxed Warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair); advises restricting use for allergic rhinitis [cited 2002 Sep 8]. Available from: https://www.fda.gov/drugs/drug-safety-and-availability/fda-requires-boxed-warning-about-serious-mental-health-side-effects-asthma-and-allergy-drug
  26. Marschallinger J, Schäffner I, Klein B, Gelfert R, Rivera FJ, Illes S, et al. Structural and functional rejuvenation of the aged brain by an approved anti-asthmatic drug. Nat Commun. 2015;6:8466. doi: 10.1038/ncomms9466
  27. Blackman JA, Gurka MJ. Developmental and behavioral comorbidities of asthma in children. J Dev Behav Pediatr. 2007;28(2):92–99. doi: 10.1097/01.dbp.0000267557.80834.e5
  28. Easter G, Sharpe L, Hunt CJ. Systematic review and meta-analysis of anxious and depressive symptoms in caregivers of children with asthma. J Pediatr Psychol. 2015;40(7):623–632. doi: 10.1093/jpepsy/jsv012
  29. Wallerstedt SM, Brunlof G, Sundstrom A, Eriksson AL. Montelukast and psychiatric disorders in children. Pharmacoepidemiol Drug Saf. 2009;18(9):858–864. doi: 10.1002/pds.1794

补充文件

附件文件
动作
1. JATS XML
下载

版权所有 © Pharmarus Print Media, 2020

##common.cookie##