Practical aspects of the using levosalbutamol in adults and children: Resolution of the Council of Experts
S. N. Avdeev,
L. S. Namazova-Baranova,
Z. R. Aisanov,
V. N. Antonov,
V. V. Arkhipov,
E. A. Borodulina,
A. A. Vizel,
E. A. Vishneva,
I. V. Demko,
A. V. Emelyanov,
G. L. Ignatova,
O. M. Kurbacheva,
I. V. Leshсhenko,
N. M. Nenasheva https://doi.org/10.18093/0869-0189-2024-34-4-576-584
Abstract
The purpose of publishing the resolution of the Interdisciplinary Council of Experts in the fields of pulmonology, allergology, pediatrics, and clinical pharmacology was to discuss the effectiveness and safety of a new short-acting β2-adrenergic receptor agonist in the Russian Federation – levosalbutamol. The Interdisciplinary Council of Experts in the fields of pulmonology, allergology, pediatrics, and clinical pharmacology took place on March 19, 2024 in Moscow. Results. According to the research results, the following advantages of using levosalbutamol have been demonstrated: the affinity for β2-adrenergic receptors is 2 times higher compared to salbutamol; the drug affects the sensitization of β2 receptors to a lesser degree; levosalbutamol does not cause increased airway hyperresponsiveness; levosalbutamol has a more pronounced anti-inflammatory effect; greater safety for the cardiovascular system was noted. Conclusion. According to the presented data, the inclusion of levosalbutamol in clinical guidelines for asthma (age category “children, adults”) and chronic obstructive pulmonary disease (age category “adults”) is justified.
Supporting agencies: This article was prepared with the financial support of Glenmark Pharmaceuticals, Ltd.
About the Authors
S. N. Avdeev
Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University); Federal State Budgetary Institution “Pulmonology Scientific Research Institute” under Federal Medical and Biological Agency of Russian Federation
Russian Federation
Competing Interests:
Russian Federation
Sergey N. Avdeev - Doctor of Medicine, Professor, Academician of Russian Academy of Sciences, Head of the Department of Pulmonology, N.V.Sklifosovsky Institute of Clinical Medicine, Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University), Leading Researcher, Federal State Budgetary Institution “Pulmonology Scientific Research Institute” under Federal Medical and Biological Agency of Russian Federation; Chief Freelance Pulmonologist of the Ministry of Health of the Russian Federation; Director of the National Medical Research Center for Pulmonology.
Trubetskaya ul. 8, build. 2, Moscow, 119991; Orekhovyy bul’var 28, Moscow, 115682
Tel.: (495) 708-35-76
Competing Interests:
None
L. S. Namazova-Baranova
Federal State Autonomous Educational Institution of Higher Education “N.I. Pirogov Russian National Research Medical University” of the Ministry of Health of the Russian Federation; Research Institute of Pediatrics and Children’s Health, Scientific and Clinical Center No.2, Federal State Budgetary Scientific Institution “Petrovsky National Research Centre of Surgery”
Russian Federation
Competing Interests:
Russian Federation
Leyla S. Namazova-Baranova - Doctor of Medicine, Professor, Academician of the Russian Academy of Sciences, Head of Faculty Pediatrics Department, Pediatric Faculty, Federal State Autonomous Educational Institution of Higher Education “N.I. Pirogov Russian National Research Medical University” of the Ministry of Health of the Russian Federation; Head of the Research Institute of Pediatrics and Children’s Health, Scientific and Clinical Center No.2, Federal State Budgetary Scientific Institution “Petrovsky National Research Centre of Surgery”.
Ostrovityanova ul. 1, Moscow, 117997; Fotiyevoy ul. 10, build. 1, Moscow, 117593
Tel.: (499) 400-47-33
Competing Interests:
None
Z. R. Aisanov
Federal State Autonomous Educational Institution of Higher Education “N.I. Pirogov Russian National Research Medical University” of the Ministry of Health of the Russian Federation
Russian Federation
Competing Interests:
Russian Federation
Zaurbek R. Aisanov - Doctor of Medicine, Professor. Professor, Department of Pulmonology, Faculty of Additional Professional Education, Federal State Autonomous Educational Institution of Higher Education “N.I. Pirogov Russian National Research Medical University” of the Ministry of Health of the Russian Federation.
Ostrovityanova ul. 1, Moscow, 117997
Tel.: (495) 965-34-66
Competing Interests:
None
V. N. Antonov
Federal State Budgetary Educational Institution of Higher Education “South-Ural State Medical University” of the Ministry of Healthcare of the Russian Federation
Russian Federation
Competing Interests:
Russian Federation
Vladimir N. Antonov - Doctor of Medicine, Professor, Department of Therapy, Institute of Additional Professional Education, Chief Researcher, Institute of Pulmonology, Federal State Budgetary Educational Institution of Higher Education “South-Ural State Medical University” of the Ministry of Healthcare of the Russian Federation.
Vorovskogo ul. 64, Chelyabinsk, 454092
Tel.: (351) 742-66-40
Competing Interests:
None
V. V. Arkhipov
Federal State Budgetary Educational Institution of Additional Professional Education “Russian Medical Academy of Continuous Professional Education”, Ministry of Health of Russia
Russian Federation
Competing Interests:
Russian Federation
Vladimir V. Arkhipov - Doctor of Medicine, Professor, Department of Clinical Pharmacology and Therapy, Federal State Budgetary Educational Institution of Additional Professional Education “Russian Medical Academy of Continuous Professional Education”, Ministry of Health of Russia.
Barrikadnaya ul. 2/1, Moscow, 123995
Tel.: (499) 252-21-04
Competing Interests:
None
E. A. Borodulina
Federal State Budgetary Educational Institution of Higher Education “Samara State Medical University” of the Ministry of Healthcare of the Russian Federation
Russian Federation
Competing Interests:
Russian Federation
Elena A. Borodulina - Doctor of Medicine, Professor, Head of the Department of Phthisiology and Pulmonology, Federal State Budgetary Educational Institution of Higher Education “Samara State Medical University” of the Ministry of Healthcare of the Russian Federation.
Chapaevskaya ul. 89, Samara, 443099
Tel.: (846) 374-10-04 (add. 4763)
Competing Interests:
None
A. A. Vizel
Federal State Budgetary Educational Institution of Higher Education Kazan State Medical University of the Ministry of Health of the Russian Federation
Russian Federation
Competing Interests:
Russian Federation
Aleksandr A. Vizel - Doctor of Medicine, Professor, Head of Department of Phthisiology and Pulmonology, Federal State Budgetary Educational Institution of Higher Education “Kazan State Medical University” of the Ministry of Health of the Russian Federation.
Butlerova ul. 49, Kazan, 420012, Republic of Tatarstan
Tel.: (843) 236-09-22
Author ID: 195447
Competing Interests:
None
E. A. Vishneva
Research Institute of Pediatrics and Children’s Health, Scientific and Clinical Center No.2, Federal State Budgetary Scientific Institution “Petrovsky National Research Centre of Surgery”; Federal State Autonomous Educational Institution of Higher Education “N.I. Pirogov Russian National Research Medical University” of the Ministry of Health of the Russian Federation
Russian Federation
Competing Interests:
Russian Federation
Elena A. Vishneva - Doctor of Medicine, Professor of Russian Academy of Sciences, Deputy Head for Science, Research Institute of Pediatrics and Children’s Health, Scientific and Clinical Center No.2, Federal State Budgetary Scientific Institution “Petrovsky National Research Centre of Surgery”; Professor, Department of Faculty Pediatrics of the Pediatric Faculty, Federal State Autonomous Educational Institution of Higher Education “N.I. Pirogov Russian National Research Medical University” of the Ministry of Health of the Russian Federation.
Fotiyevoy ul. 10, build. 1, Moscow, 117593; Ostrovityanova ul. 1, Moscow, 117997
Tel.: (499) 400-47-33
Competing Interests:
None
I. V. Demko
Federal State Budgetary Educational Institution of Higher Education “Krasnoyarsk State Medical University named after Professor V.F. Voyno-Yasenetsky”
Russian Federation
Competing Interests:
Russian Federation
Irina V. Demko - Doctor of Medicine, Professor, Head of the Department of Hospital Therapy and Immunology with postgraduate education course, Federal State Budgetary Educational Institution of Higher Education “Krasnoyarsk State Medical University named after Professor V.F. Voyno-Yasenetsky” of the Ministry of Health of the Russian Federation; Chief Pulmonologist-Allergist of the Siberian Federal District.
Partizana Zheleznyaka ul. 1, Krasnoyarsk, 660022
Tel.: (913) 507-84-08
Competing Interests:
None
A. V. Emelyanov
Federal State Budgetary Educational Institution of Higher Education “North-Western State Medical University named after I.I. Mechnikov”, Ministry of Health of the Russian Federation
Russian Federation
Competing Interests:
Russian Federation
Alexander V. Emelyanov - Doctor of Medicine, Professor, Head of Department of Pulmonology, North-Western State Medical University named after I.I. Mechnikov, Ministry of Health of the Russian Federation.
Kirochnaya ul. 41, SaintPetersburg, 191015
Tel.: (812) 970-71-88
Competing Interests:
None
G. L. Ignatova
Federal State Budgetary Educational Institution of Higher Education “South-Ural State Medical University” of the Ministry of Healthcare of the Russian Federation
Russian Federation
Competing Interests:
Russian Federation
Galina L. Ignatova - Doctor of Medicine, Professor, Head of Department of Therapy, Institute of Postgraduate Physician Training, Director, Institute of Pulmonology, Federal State Budgetary Educational Institution of Higher Education “South-Ural State Medical University” of the Ministry of Healthcare of the Russian Federation; Chief Pulmonologist, Ural Federal District.
Vorovskogo ul. 64, Chelyabinsk, 454092
Tel.: (351) 742-66-40
Competing Interests:
None
O. M. Kurbacheva
National Research Center – Institute of Immunology Federal Medical-Biological Agency of Russia; Federal state budgetary educational institution of higher education “Russian University of Medicine” of the Ministry of Health of the Russian Federation
Russian Federation
Competing Interests:
Russian Federation
Oksana M. Kurbacheva - Doctor of Medicine, Professor, Head of the Department of Bronchial Asthma, National Research Center – Institute of Immunology Federal Medical-Biological Agency of Russia; Associate Professor, Department of Clinical Allergology and Immunology, Federal state budgetary educational institution of higher education “Russian University of Medicine” of the Ministry of Health of the Russian Federation.
Kashirskoe shosse 24, Moscow, 115522; Delegatskaya ul. 20/1, Moscow, 127473
Tel.: (499) 311-67-78
Competing Interests:
None
I. V. Leshсhenko
Federal State Budget Educational Institution of Higher Education “Ural State Medical University” of the Ministry of Health of the Russian Federation; Ural Federal Research Institute of Phthisiology and Pulmonology – A Branch of National Medical Research Center for Phthisiology, Pulmonology and Infectious Diseases, Healthcare Ministry of Russia; Limited Liability Company “Novaya bol’nitsa” Clinical Association
Russian Federation
Competing Interests:
Russian Federation
Igor V. Leshсhenko - Doctor of Medicine, Professor; Professor, Department of Infectious Diseases, Phthisiology and Pulmonology, Federal State Budget Educational Institution of Higher Education “Ural State Medical University” of the Ministry of Health of the Russian Federation; Chief Researcher, Ural Federal Research Institute of Phthisiology and Pulmonology – a Branch of National Medical Research Center for Phthisiology, Pulmonology and Infectious Diseases, Healthcare Ministry of Russia; Scientific Director, Limited Liability Company “Novaya bol’nitsa” Clinical Association, Chief Freelance Pulmonologist, Healthcare Ministry of the Sverdlovsk Region, Honored Doctor of the Russian Federation.
Repina ul. 3, Ekaterinburg, 620028; 22-go Parts’ezda ul. 50, Ekaterinburg, 620039; Zavodskaya ul. 29, Ekaterinburg, 620109
Tel.: (912) 288-28-23
Competing Interests:
None
N. M. Nenasheva
Federal State Budgetary Educational Institution of Additional Professional Education “Russian Medical Academy of Continuous Professional Education”, Ministry of Health of Russia
Russian Federation
Competing Interests:
Russian Federation
Natal’ya M. Nenasheva - Doctor of Medicine, Professor, Head of the Department of Allergology and Immunology, Federal State Budgetary Educational Institution of Additional Professional Education “Russian Medical Academy of Continuous Professional Education”, Ministry of Health of Russia.
Barrikadnaya ul. 2/1, Moscow, 123995
Tel.: (495) 685-13-95
Competing Interests:
None
References
1. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention. 2023 GINA Report. Available at: https://ginasthma.org/2023-gina-main-report/ [Accessed November 21, 2023].
2. World Health Organization. Asthma. Available at: https://www.who.int/news-room/fact-sheets/detail/asthma [Accessed November 21, 2023].
3. Bystritskaya E.V., Bilichenko T.N. [The review of the bronchial asthma morbidity in the population of the Russian Federation]. Pul'monologiya. 2022; 32 (5): 651–660. DOI: 10.18093/0869-0189-2022-32-5-651-660 (in Russian).
4. Chuchalin A.G., Avdeev S.N., Aisanov Z.R. et al. [Federal guidelines on diagnosis and treatment of bronchial asthma]. Pul'monologiya. 2022; 32 (3): 393–447. DOI: 10.18093/0869-0189-2022-32-3-393-447 (in Russian).
5. Drugbank online. Salbutamol. Available at: https://go.drugbank.com/drugs/DB01001 [Accessed: November 21, 2023].
6. Aldridge R.E., Hancox R.J., Robin T.D. et al. Effects of terbutaline and budesonide on sputum cells and bronchial hyperresponsiveness in asthma. Am. J. Respir. Crit. Care Med. 2000; 161 (5): 1459–1464. DOI: 10.1164/ajrccm.161.5.9906052.
7. Cockcroft D.W., Swystun V.A. Functional antagonism: tolerance produced by inhaled beta 2 agonists. Thorax. 1996; 51 (10): 1051–1056. DOI: 10.1136/thx.51.10.1051.
8. Mitchell E.A. Is current treatment increasing asthma mortality and morbidity? Thorax. 1989; 44 (2): 81–84. DOI: 10.1136/thx.44.2.81.
9. Wraight J.M., Hancox R.J., Herbison G.P. et al. Bronchodilator tolerance: the impact of increasing bronchoconstriction. Eur. Respir. J. 2003; 21 (5): 810–815. DOI: 10.1183/09031936.03.00067503.
10. Daley-Yates P., Aggarwal B., Lulic Z. et al. Pharmacology versus convenience: a benefit/risk analysis of regular maintenance versus infrequent or as-needed inhaled corticosteroid use in mild asthma. Adv. Ther. 2022; 39 (1): 706–726. DOI: 10.1007/s12325-021-01976-4.
11. Domingo С., Singh D. The changing asthma management landscape and need for appropriate SABA prescription. Adv. Ther. 2023; 40 (4): 1301–1316. DOI: 10.1007/s12325-022-02410-z.
12. O'Byrne P.M., FitzGerald J.M., Bateman E.D. et. al. Inhaled combined budesonide-formoterol as needed in mild asthma. N. Engl. J. Med. 2018; 378 (20): 1865–1876. DOI: 10.1056/NEJMoa1715274.
13. Bateman E.D., Reddel H.K., O'Byrne P.M. et. al. As-needed budesonide-formoterol versus maintenance budesonide in mild asthma. N. Engl. J. Med. 2018; 378 (20): 1877–1887. DOI: 10.1056/NEJMoa1715275.
14. Hardy J., Baggott C., Fingleton J. et al. Budesonide-formoterol reliever therapy versus maintenance budesonide plus terbutaline reliever therapy in adults with mild to moderate asthma (PRACTICAL): a 52-week, openlabel, multicentre, superiority, randomised controlled trial. Lancet. 2019; 394 (10202): 919–912. DOI: 10.1016/S0140-6736(19)31948-8.
15. Beasley R., Holliday M., Reddel H.K. et al. Controlled trial of budesonide-formoterol as needed for mild asthma. N. Engl. J. Med. 2019; 380 (21): 2020–2030. DOI: 10.1056/NEJMoa1901963.
16. Amirav I., Garcia G., Le B.K. et al. SABAs as reliever medications in asthma management: evidence-based science. Adv. Ther. 2023; 40 (7): 2927–2943. DOI: 10.1007/s12325-023-02543-9.
17. Avdeev S.N., Leshchenko I.V., Aisanov Z.R. [New concept and algorithm for the management of patients with chronic obstructive pulmonary disease]. Pul'monologiya. 2023; 33 (5): 587-594. DOI: 10.18093/0869-0189-2023-33-5-587-594 (in Russian).
18. Bellamy D., Hutchison D.C. The effects of salbutamol aerosol on lung function in patients with pulmonary emphysema. Br. J. Dis. Chest. 1981; 75 (2):190–196. DOI: 10.1016/0007-0971(81)90052-8.
19. Chan C.S., Brown I.G., Kelly C.A. et al. Bronchodilator responses to nebulised ipratropium and salbutamol singly and in combination in chronic bronchitis. Br. J. Clin. Pharmac. 1984; 17: 103–105. DOI: 10.1111/j.1365-2125.1984.tb05008.x.
20. Cherniak A.V., Avdeev S.N., Pashkova T.L., Aisanov Z.R. [Bronchodilating test in patients with chronic obstructive pulmonary disease]. Pul'monologiya. 2003; (1): 51–56. Available at: https://journal.pulmonology.ru/pulm/article/view/2702/2131 (in Russian).
21. Truitt T., Witko J., Halpern M. Levalbuterol compared to racemic albuterol: efficacy and outcomes in patients hospitalized with COPD or asthma. Chest. 2003; 123 (1): 128–135. DOI: 10.1378/chest.123.1.128.
22. Vizel' I.Yu., Salakhova I.N., Shmelev E.I. [Chronic obstructive pulmonary disease: from recommendations to actual practice in the Republic of Tatarstan]. Vestnik TsNIIT. 2020; (3): 49–57. DOI: 10.7868/S2587667820030073 (in Russian).
23. Vizel A.A., Rezyapova A.I., Vizel I.Yu. [Comparison of the correct use of different types of inhalers in patients with COPD and bronchial asthma]. Tuberkulez i bolezni legkikh. 2023;101 (3): 6–14. DOI: 10.58838/2075-1230-2023-101-3-6-14 (in Russian).
24. Page C.P., Morley J. Contrasting properties of albuterol stereoisomers. J. Allergy Clin. Immunol. 1999; 104 (2, Pt 2): S31–S41. DOI: 10.1016/s0091-6749(99)70271-x.
25. Penn R.B., Frielle T., McCullough J.R. et al. Comparison of R-, S-, and RS-albuterol interaction with human beta 1- and beta 2-adrenergic receptors. Clin. Rev. Allergy Immunol. 1996; 14 (1): 37–45. DOI: 10.1007/BF02772201.
26. Chhabra N., Aseri M.L., Padmanabhan D. A review of drug isomerism and its significance. Int. J. Appl. Basic Med. Res. 2013; 3 (1): 16–18. DOI: 10.4103/2229-516X.112233.
27. Čižmáriková R., Valentová J., Horáková R. Chirality of β2-agonists. An overview of pharmacological activity, stereoselective analysis, and synthesis. Open Chemistry. 2020; 18 (1): 628–647. DOI: 10.1515/chem-2020-0056.
28. Penn R.B., Frielle T., McCullough J.R. et al. Comparison of R-, S-, and RS-albuterol interaction with human beta 1- and beta 2-adrenergic receptors. Clin. Rev. Allergy Immunol. 1996; 14 (1): 37–45. DOI: 10.1007/BF02772201.
29. Mitra S., Ugur M., Ugur O. et al. (S)-Albuterol increases intracellular free calcium by muscarinic receptor activation and a phospholipase C-dependent mechanism in airway smooth muscle. Mol. Pharmacol. 1998; 53 (3): 347–354. DOI: 10.1124/mol.53.3.347.
30. Williams D.M., Rubin B.K. Clinical pharmacology of bronchodilator medications. Respir. Care. 2018; 63 (6): 641–654. DOI: 10.4187/respcare.06051.
31. Lötvall J., Palmqvist M., Ankerst J. et al. The effect of formoterol over 24 h in patients with asthma: the role of enantiomers. Pulm. Pharmacol. Ther. 2005; 18 (2): 109–113. DOI: 10.1016/j.pupt.2004.10.007.
32. Matera M.G., Ora J., Cazzola M. et al. Differential pharmacology and clinical utility of long-acting bronchodilators in COPD – focus on olodaterol. Ther. Clin. Risk Manag. 2015; 11: 1805–1811. DOI: 10.2147/TCRM.S73581.
33. Nelson H.S., Bensch G., Pleskow W.W. et al. Improved bronchodilation with levalbuterol compared with racemic albuterol in patients with asthma. J. Allergy Clin. Immunol. 1998; 102 (6, Pt 1): 943–952. DOI: 10.1016/s0091-6749(98)70332-x.
34. Volcheck G.W., Kelkar P., Bartemes K.R. et al. Effects of (R)- and (S)-isomers of beta-adrenergic agonists on eosinophil response to interleukin-5. Clin. Exp. Allergy. 2005; 35 (10): 1341–1346. DOI: 10.1111/j.1365-2222.2005.02347.x.
35. Gumbhir-Shah K., Kellerman D.J., DeGraw S. et al. Pharmacokinetic and pharmacodynamic characteristics and safety of inhaled albuterol enantiomers in healthy volunteers. J. Clin. Pharmacol. 1998; 38 (12): 1096–1106. Available at: https://accp1.onlinelibrary.wiley.com/doi/abs/10.1177/009127009803801203
36. Nowak R., Emerman C., Hanrahan J.P. et al. A comparison of levalbuterol with racemic albuterol in the treatment of acute severe asthma exacerbations in adults. Am. J. Emerg. Med. 2006; 24 (3): 259–267. DOI: 10.1016/j.ajem.2006.01.027.
37. Xopenex HFA (levalbuterol tartrate). Inhalation aerosol. 1999. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021730s024lbl.pdf [Accessed: Januar 01, 2024].
38. Berger W.E., Milgrom H., Skoner D.P. et al. Evaluation of levalbuterol metered dose inhaler in pediatric patients with asthma: a double-blind, randomized, placebo- and active-controlled trial. 2006; 22 (6): 1217–1226. DOI: 10.1185/030079906X112534.
39. Tripp K. , McVicar W.K., Nair P. et al. A cumulative dose study of levalbuterol and racemic albuterol administered by hydrofluoroalkane-134a metereddose inhaler in asthmatic subjects. 2008; 122 (3): 544–549. DOI: 10.1016/j.jaci.2008.06.015.
40. Kurbacheva O.M., Ilina N.I., Avdeev S.N. et al. [Efficacy and safety of levosalbutamol in patients with mild to moderate asthma compared with racemic salbutamol: results of a crossover placebo-controlled study]. Terapevticheskiy arkhiv. 2024; 96 (4): 370–377. DOI: 10.26442/00403660.2024.04.202696 (in Russian).
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Avdeev S.N., Namazova-Baranova L.S., Aisanov Z.R., Antonov V.N., Arkhipov V.V., Borodulina E.A., Vizel A.A., Vishneva E.A., Demko I.V., Emelyanov A.V., Ignatova G.L., Kurbacheva O.M., Leshсhenko I.V., Nenasheva N.M. Practical aspects of the using levosalbutamol in adults and children: Resolution of the Council of Experts. PULMONOLOGIYA. 2024;34(4):576-584. (In Russ.) https://doi.org/10.18093/0869-0189-2024-34-4-576-584
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