Новые возможности двойной бронходилатационной терапии у пациентов с хронической обструктивной болезнью легких - Журнал Терапевтический архив №3 Вопросы пульмонологии 2019

Новые возможности двойной бронходилатационной терапии у пациентов с хронической обструктивной болезнью легких

Авдеев С.Н., Трушенко Н.В. Новые возможности двойной бронходилатационной терапии у пациентов с хронической обструктивной болезнью легких. Терапевтический архив. 2019; 91 (3): #–85. DOI: 10.26442/00403660.2019.03.000136

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Avdeev S.N., Trushenko N.V. New opportunities of dual bronchodilation therapy for patients with chronic obstructive pulmonary disease. Therapeutic Archive. 2019; 91 (3): #–85. DOI: 10.26442/00403660.2019.03.000136

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Аннотация

В настоящее время комбинированные комбинации бронходилататоров длительного действия – длительно действующие β2-агонисты и длительно действующие антихолинергические препараты являются базисной терапией большинства пациентов с хронической обструктивной болезнью легких (ХОБЛ). Данные комбинации отличаются друг от друга по ряду фармакологических характеристик, а также по устройству доставки, что дает предпосылки для различий в клинической эффективности и расширяет возможности персонализированного подхода к терапии ХОБЛ. Комбинация аклидиния/формотерола отличается от других комбинаций двукратным режимом дозирования, высоким профилем безопасности, а также средством доставки. В настоящей статье приведены сведения о ее клинической эффективности и безопасности у пациентов с ХОБЛ.

Ключевые слова: хроническая обструктивная болезнь легких, двойная бронходилатация, терапия, аклидиний/формотерол.

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Currently, combinations of long-acting beta2-agonists and long-acting anticholinergics are considered as the basic therapy for majority of patients with chronic obstructive pulmonary disease (COPD). These combinations have different pharmacological characteristics and delivery devices that provides different clinical effects and new opportunities for personalized treatment of COPD. Aclidinium/formoterol fixed combination differs from other dual bronchodilators by twice-daily dosing regimen, good safety profile and a specific delivery system. Recent information on clinical efficacy and safety of aclidinium/formoterol combination in COPD patients is given in this article.

Keywords: chronic obstructive pulmonary disease, dual bronchodilation therapy, aclidinium/formoterol combination.

Список литературы

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24. Kerwin EM, D`Urzo AD, Gelb AF, et al. ACCORD I study investigators. Efficacy and safety of 12-week treatment with twice-daily aclidinium bromide in COPD patients (ACCORD COPD I). COPD. 2012;9:90-101.
25. Jones PW, Singh D, Bateman ED, et al. Efficacy and safety of treatment with twice-daily aclidinium bromide in COPD patients: the ATTAIN study. Eur Respir J. 2012;40:830-36.
26. Ni H, Soe Z, Moe S. Aclidinium bromide for stable chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2014;19.9:CD010509.
27. Verkindre C, Fukuchi Y, Flemale A, et al. Sustained 24-h efficacy of NVA237, a once-daily long-acting muscarinic antagonists, in COPD patients. Resp Med. 2010;104:1482-9.
28. Watz H, Beeh KM, Magnussen H, et al. Effect of aclidinium bromide on static lung function and hyperinflation in patients with moderate to severe COPD. Eur Respir J. 2013;42:4633.
29. Campbell M, Eliraz A, Johansson G, et al. Formoterol for maintenance and as-needed treatment of chronic obstructive pulmonary disease. Respir Med. 2005;99:1511-20.
30. Cote C, Pearle JL, Sharafkhaneh A, Spangenthal S. Faster onset of action of formoterol versus salmeterol in patients with chronic obstructive pulmonary disease: a multicenter, randomized study. Pulm Pharmacol Ther. 2009;22:44-9.
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34. Singh D, Jones PW, Bateman ED, et al. Efficacy and safety of aclidinium bromide/ formoterol fumarate fixed-dose combinations compared with individual components and placebo in patients with COPD (ACLIFORM-COPD): a multicentre, randomised study. BMC Pulm Med. 2014;14:178.
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38. Agusti A, Hedner J, Marin JM, et al. Night-time symptoms: a forgotten dimension of COPD. Eur Respir Rev. 2011;20:183-94.
39. Kim YJ, Lee BK, Jung CY, et al. Patient’s perception of symptoms related to morning activity in chronic obstructive pulmonary disease: the SYMBOL Study. Korean J Intern Med. 2012;27:426-35.
40. Roche N, Chavannes NH, Miravitlles M. COPD symptoms in the morning: impact, evaluation and management. Respir Res. 2013;14:112.
41. Lange P, Marott JL, Vestbo J, Nordestgaard BG. Prevalence of night-time dyspnoea in COPD and its implications for prognosis. Eur Respir J. 2014;43:1590-8.
42. Price D, Small M, Milligan G, et al. Impact of night-time symptoms in COPD: a real-world study in five European countries. Int J COPD. 2013;8:595-603.
43. Miravitlles M, Chapman KR, Chuecos F, Ribera A, Gil EG. The efficacy of aclidinium/formoterol on lumg function and symptoms in patients with COPD categorized by symptom status: a pooled analysis. Int J COPD. 2016;11:2041-53.
44. Waschki B, Spruit MA, Watz H, et al. Physical activity monitoring in COPD: compliance and associations with clinical characteristics in a multicenter study. Respir Med. 2012;106:522-30.
45. Demeyer H, Louvaris Z, Frei A, et al. Physical activity is increased by a 12-week semiautomated telecoaching programme in patients with COPD: a multicentre randomised controlled trial. Thorax. 2017;72:415-23.
46. Donaire-Gonzalez D, Gimeno-Santos E, Balcells E, et al. Benefits of physical activity on COPD hospitalisation depend on intensity. Eur Respir J. 2015;46:1281-9.
47. Waschki B, Kirsten AM, Holz O, et al. Disease progression and changes in physical activity in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2015;192:295-306.
48. Waschki B, Kirsten A, Holz O, et al. Physical activity is the strongest predictor of all-cause mortality in patients with COPD: a prospective cohort study. Chest. 2011;140:331-42.
49. Troosters T, van der Molen T, Polkey M, et al. Improving physical activity in COPD: towards a new paradigm. Respir Res. 2013;14:115.
50. Demeyer H, Burtin C, Hornikx M, et al. The minimal important difference in physical activity in patients with COPD. PLoS One. 2016;11:e0154587.
51. Vogelmeier C, Paggiaro PL, Dorca J, Sliwinski P, Mallet M et al. Efficacy and safety of aclidinium/formrterol versus salmeterol/fluticasone: a phase 3 COPD study. Eur Respir J. 2016;48:1030-9.
52. Medic G, Lindner L, van der Weijden M, Karabis A. Efficacy and safety of aclidinium/formoterol versus tiotropium in COPD: results of an indirect treatment comparison. Adv Ther. 2016;33:379-99.
53. Make B. Safety and tolerability of fixed-dose combination aclidinium bromide/formoterol fumarate: results of two 6-month studies in patients with moderate to severe COPD. Am J Respir Crit Care Med. 2014;189:A6009.
54. Donohue JF, Soong W, et al. Lung function and safety of aclidinium bromide/formoterol fumarate fixed-dose combination: results of a 1-year trial in patients with COPD. Respir Med. 2016;116:41-8.
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1. GOLD. Global Strategy for the Diagnosis, Management and Prevention of COPD. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Updated 2018. Available from http://www.goldcopd.org/
2. Avdeev SN, Trushenko NV Dual bronchodilatator therapy – new paradigm for chronic obstructive pulmonary disease treatment Practical pulmonology 2015;3:24-32
3. Ford ES. Hospital discharges. readmissions, and ED visits for COPD or bronchiectasis among US adults: findings from the nationwide inpatient sample 2001–2012 and nationwide emergency department sample 2006–2011. Chest. 2015;147:989-98.
4. Ingebrigtsen TS, Marott JL, Nordestgaard BG, et al. Low use and adherence to maintenance medication in chronic obstructive pulmonary disease in the general population. J Gen Intern Med. 2015;30:51-9.
5. Bender BG. Nonadherence in chronic obstructive pulmonary disease patients: what do we know and what should we do next? Curr Opin Pulm Med. 2014;20:132-7.
6. Cazzola M, Calzetta L, Page CP, Rogliani P, Facciolo F, et al. Translational study searching for synergy between glycopyrronium and indacaterol. COPD. 2014;12:175-81.
7. Сazzola M, Molimard M. The scientific rationale for combining long-acting beta-2-agonists and muscarinic antagonist in COPD. Pulm Pharmacol Ther. 2010;23:257-67.
8. Trofimov VI, Sorokina LN. Mechanisms of anticholinergic effects and probable mechanisms of their potentiation using beta-2-agonists. Pulmonology. 2014;2:91-9 (In Russ.)
9. Van der Molen T, Cazzola M. Beyond lung function in COPD management: effectiveness of LABA/LAMA combination therapy on patient-centred outcomes. Prim Care Respir J. 2012;21:101-8.
10. Deas SD, Huprikar N. Dual bronchodilatator therapy for chronic obstructive pulmonary disease: evidence for the efficacy and safety of fixed dose combination treatments in the setting of recent guideline updates. Curr Opin Pulm Med. 2018;24:130-7.
11. Avdeev SN, Trushenko NV. Fixed combination of indacaterol/glycopyrronium for COPD treatment: review. Pulmonology. 2018;28(2):224-33 (In Russ.)
12. D’Urzo T, Donohue JF, Price D, Miravitlles M, Kerwin E. Dual bronchodilator therapy with aclidinium bromide/formoterol fumarate for chronic obstructive pulmonary disease. Expert Rev Respir Med. 2015:9(5):519-32.
13. Wedzicha JA, Banerji D, Chapman KR Indacaterol-Glycopirronium versus Salmeterol-Fluticasone for COPD. N Engl J Med. 2016;374:2222-34.
14. Lee JH, Lee YK, Kim EK, et al. Responses to inhaled long-acting beta-agonist and corticosteroid according to COPD subtype. Respir Med. 2010;104:542-9.
15. Miravitlles M, Calle M, Soler-Cataluna JJ. Clinical phenotypes of COPD: identification, definition and implications for guidelines. Arch Bronconeumol. 2012;48:86-98.
16. Maltais F, Singh S, Donald AC, et al. Effects of a combination of umeclidinium/ vilanterol on exercise endurance in patients with chronic obstructive pulmonary disease: two randomized, double-blind clinical trials. Ther Adv Respir Dis. 2014;8:169-81.
17. Aisanov ZR, Avdeev SN, Arkhipov VV, Belevskiy AS, Leshchenko IV, Ovcharenko SI, Shmelev EI, Chuchalin AG National clinical guidelines on diagnosis and treatment of chronic obstructive pulmonary disease: a clinical decision making algorithm. Pulmonology. 2017;27(1):13-20 (In Russ.)
18. Sharafkhaneh A, Altan AE, Colice GL, et al. A simple rule to identify patients with chronic obstructive pulmonary disease who may need treatment reevaluation. Respir Med. 2014;108:1310-20.
19.Avdeev SN, Trushenko NV. New perspectives in therapy of chronic obstructive pulmonary disease: revolving around aclidinium bromide. Pulmonology. 2015;25(6):725-35 (In Russ.)
20. Milara J, Gabarda E, Gavalda A, et al. An assessment of the functional profile of aclidinium in human bronchi and left atria. Eur Respir J. 2011;38:859.
21. Rogliani P, Calzetta L, Ora J, et. al. Pharmacological assessment of the onset of action of aclidinium and glycopyrronium versus tiotropium in COPD patients and human isolated bronchi. Eur J Pharmacol. 2015;761:383-90.
22. Gavalda A, Ramos I, Carcasona C, et al. The in vitro and in vivo profile of aclidinium bromide in comparison with glycopyrronium bromide. Pulmonary Pharmacology & Therapeutics. 2014;28:114-21.
23. Lopez-Campos JL, Calero C, Lopez-Ramirez C, et al. Patient-reported outcomes and considerations in the management of COPD: focus on aclidinium. Patient Preference and Adherence. 2015;9:95-104.
24. Kerwin EM, D`Urzo AD, Gelb AF, et al. ACCORD I study investigators. Efficacy and safety of 12-week treatment with twice-daily aclidinium bromide in COPD patients (ACCORD COPD I). COPD. 2012;9:90-101.
25. Jones PW, Singh D, Bateman ED, et al. Efficacy and safety of treatment with twice-daily aclidinium bromide in COPD patients: the ATTAIN study. Eur Respir J. 2012;40:830-36.
26. Ni H, Soe Z, Moe S. Aclidinium bromide for stable chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2014;19.9:CD010509.
27. Verkindre C, Fukuchi Y, Flemale A, et al. Sustained 24-h efficacy of NVA237, a once-daily long-acting muscarinic antagonists, in COPD patients. Resp Med. 2010;104:1482-9.
28. Watz H, Beeh KM, Magnussen H, et al. Effect of aclidinium bromide on static lung function and hyperinflation in patients with moderate to severe COPD. Eur Respir J. 2013;42:4633.
29. Campbell M, Eliraz A, Johansson G, et al. Formoterol for maintenance and as-needed treatment of chronic obstructive pulmonary disease. Respir Med. 2005;99:1511-20.
30. Cote C, Pearle JL, Sharafkhaneh A, Spangenthal S. Faster onset of action of formoterol versus salmeterol in patients with chronic obstructive pulmonary disease: a multicenter, randomized study. Pulm Pharmacol Ther. 2009;22:44-9.
31. Derom E, Strandgården K, Schelfhout V, Borgström L, Pauwels R. Lung deposition and efficacy of inhaled formoterol in patients with moderate to severe COPD. Respir Med. 2007;101:1931-41.
32. D’Urzo AD, Rennard SI, Kerwin EM, et al. Efficacy and safety of fixed-dose combinations of aclidinium bromide/ formoterol fumarate: the 24-week, randomized, placebo-controlled AUGMENT COPD study. Respir Res. 2014;15:123.
33. Efficacy, safety and tolerability of aclidinium bromide/formoterol fumarate compared with formoterol fumarate in patients with moderate to severe chronic obstructive pulmonary disease (COPD) (LAC). Available from: https://clinicaltrials.gov/ct2/ show/NCT01437397
34. Singh D, Jones PW, Bateman ED, et al. Efficacy and safety of aclidinium bromide/ formoterol fumarate fixed-dose combinations compared with individual components and placebo in patients with COPD (ACLIFORM-COPD): a multicentre, randomised study. BMC Pulm Med. 2014;14:178.
35. Avdeev SN. Scheme of therapy with Berodual for stable chronic obstructive pulmonary disease and exacerbations. Practical pulmonology. 2014;3:20-5 (In Russ.)
36. Watz H, Troosters T, Beeh KM, Garcia-Aymerich J, Paggiaro P, Molins E, Notari M, Zapata A, Jarreta D. Gil EG ACTIVATE: the effect of aclidinium/formoterol on hyperinflation, exercise capacity, and physical activity in patients with COPD. Int J COPD. 2017;12:2545-58.
37. Jones PW, Beeh KM, Chapman KR, et al. Minimal clinically important differences in pharmacological trials. Am J Respir Crit Care Med. 2014;189:250-5.
38. Agusti A, Hedner J, Marin JM, et al. Night-time symptoms: a forgotten dimension of COPD. Eur Respir Rev. 2011;20:183-94.
39. Kim YJ, Lee BK, Jung CY, et al. Patient’s perception of symptoms related to morning activity in chronic obstructive pulmonary disease: the SYMBOL Study. Korean J Intern Med. 2012;27:426-35.
40. Roche N, Chavannes NH, Miravitlles M. COPD symptoms in the morning: impact, evaluation and management. Respir Res. 2013;14:112.
41. Lange P, Marott JL, Vestbo J, Nordestgaard BG. Prevalence of night-time dyspnoea in COPD and its implications for prognosis. Eur Respir J. 2014;43:1590-8.
42. Price D, Small M, Milligan G, et al. Impact of night-time symptoms in COPD: a real-world study in five European countries. Int J COPD. 2013;8:595-603.
43. Miravitlles M, Chapman KR, Chuecos F, Ribera A, Gil EG. The efficacy of aclidinium/formoterol on lumg function and symptoms in patients with COPD categorized by symptom status: a pooled analysis. Int J COPD. 2016;11:2041-53.
44. Waschki B, Spruit MA, Watz H, et al. Physical activity monitoring in COPD: compliance and associations with clinical characteristics in a multicenter study. Respir Med. 2012;106:522-30.
45. Demeyer H, Louvaris Z, Frei A, et al. Physical activity is increased by a 12-week semiautomated telecoaching programme in patients with COPD: a multicentre randomised controlled trial. Thorax. 2017;72:415-23.
46. Donaire-Gonzalez D, Gimeno-Santos E, Balcells E, et al. Benefits of physical activity on COPD hospitalisation depend on intensity. Eur Respir J. 2015;46:1281-9.
47. Waschki B, Kirsten AM, Holz O, et al. Disease progression and changes in physical activity in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2015;192:295-306.
48. Waschki B, Kirsten A, Holz O, et al. Physical activity is the strongest predictor of all-cause mortality in patients with COPD: a prospective cohort study. Chest. 2011;140:331-42.
49. Troosters T, van der Molen T, Polkey M, et al. Improving physical activity in COPD: towards a new paradigm. Respir Res. 2013;14:115.
50. Demeyer H, Burtin C, Hornikx M, et al. The minimal important difference in physical activity in patients with COPD. PLoS One. 2016;11:e0154587.
51. Vogelmeier C, Paggiaro PL, Dorca J, Sliwinski P, Mallet M et al. Efficacy and safety of aclidinium/formrterol versus salmeterol/fluticasone: a phase 3 COPD study. Eur Respir J. 2016;48:1030-9.
52. Medic G, Lindner L, van der Weijden M, Karabis A. Efficacy and safety of aclidinium/formoterol versus tiotropium in COPD: results of an indirect treatment comparison. Adv Ther. 2016;33:379-99.
53. Make B. Safety and tolerability of fixed-dose combination aclidinium bromide/formoterol fumarate: results of two 6-month studies in patients with moderate to severe COPD. Am J Respir Crit Care Med. 2014;189:A6009.
54. Donohue JF, Soong W, et al. Lung function and safety of aclidinium bromide/formoterol fumarate fixed-dose combination: results of a 1-year trial in patients with COPD. Respir Med. 2016;116:41-8.
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Авторы

С.Н. Авдеев 1,2, Н.В. Трушенко 1,2

1 ФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава России (Сеченовский Университет), Москва, Россия;
2 ФГБУ «Научно-исследовательский институт пульмонологии» ФМБА России, Москва, Россия

________________________________________________

S.N. Avdeev 1,2, N.V. Trushenko 1,2

1 I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University), Moscow, Russia;
2 Pulmonology Scientific Research Institute under Federal Medical and Biological Agency of Russian Federation, Moscow, Russia

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