Новые перспективы в лечении хронической обструктивной болезни легких: в фокусе – аклидиния бромид
https://doi.org/10.18093/0869-0189-2015-25-6-725-735
Аннотация
Аклидиний – новый антихолинергический препарат, предназначенный для поддерживающей терапии хронической обструктивной болезни легких (ХОБЛ). Аклидиний имеет ряд фармакокинетических особенностей, определяющих его высокий профиль безопасности и крайне низкий риск развития внелегочных побочных эффектов. В клинических исследованиях III фазы продемонстрировано, что при использовании аклидиния достоверно улучшаются функциональные показатели, уменьшается тяжесть клинических симптомов заболевания и повышается качество жизни у пациентов с ХОБЛ. В данном обзоре представлены имеющиеся на сегодня литературные данные об особенностях фармакокинетики, клинической эффективности и безопасности аклидиния.
Об авторах
С. Н. Авдеев
ФГБУ «НИИ пульмонологии» ФМБА России: 105077, Москва, ул. 11-я Парковая, 32, корп. 4
Россия
Россия
д. м. н., профессор, руководитель клинического отдела ФГБУ «НИИ пульмонологии» ФМБА России; тел. / факс: (495) 4655264
Н. В. Трушенко
ФГБУ «НИИ пульмонологии» ФМБА России: 105077, Москва, ул. 11-я Парковая, 32, корп. 4
Россия
Россия
к. м. н., научный сотрудник клинического отдела ФГБУ «НИИ пульмонологии» ФМБА России; тел. / факс: (495) 4655264
Список литературы
1. Чучалин А.Г., Авдеев С.Н., Айсанов З.Р. и др. Российское респираторное общество. Федеральные клинические рекомендации по диагностике и лечению хронической обструктивной болезни легких. Пульмонология. 2014; 3: 15–54.
2. GOLD. Global Strategy for the Diagnosis, Management and Prevention of COPD. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Updated 2015. Avail able from http://www.goldcopd.org/
3. Айсанов З.Р., Новиков Ю.К. Антихолинергические препараты в лечении хронической обструктивной болезни легких. Трудный пациент. 2012; 10 (5): 9–13.
4. Архипов В.В. Клиническая фармакология антихолинергических препаратов Практическая пульмонология. 2014; 2: 32–39.
5. Ненашева Н.М. Новые возможности достижения контроля астмы с помощью тиотропия бромида. Эффективная фармакотерапия. 2014; 29: 4–13.
6. Трофименко И.Н., Черняк Б.А. Влияние бронходилататоров на бронхиальную гиперреактивность при хронической обструктивной болезни легких. Сибирский медицинский журнал. 2014; 7: 67–70.
7. Трофимов В.И. Холинолитики в лечении больных хронической обструктивной болезни легких. Доктор.ру. 2010; 6 (57): 50–53.
8. Gavalda A., Ramos I., Carcasona C. et al. The in vitro and in vivo profile of aclidinium bromide in comparison with glycopyrronium bromide. Pulm. Pharmacol. Ther. 2014; 28 (2): 114–121.
9. 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.
10. Rogliani P., Calzetta L., Ora J. et. al. Pharmacological assessment of the onset of action of aclidinium and glycopy rronium versus tiotropium in COPD patients and human isolated bronchi. Eur. J. Pharmacol. 2015; 761: 383–390.
11. Ni H., Soe Z., Moe S. Aclidinium bromide for stable chronic obstructive pulmonary disease. Cochrane Database Syst. Rev. 2014, Sep. 19; CD010509.
12. De la Motte S., Beier J., Schmid K. et al. Pharmacokinetics and safety of aclidinium bromide in younger and elderly patients with chronic obstructive pulmonary disease. Int. J. Clin. Pharmacol. Ther. 2012; 50 (6): 403–412.
13. Jansat J.M., Lamarca R., de Miquel G. et al. Safety and pharmacokinetics of single dose of aclidinium bromide, a novel longacting, inhaled antimuscarinic, in healthy subjects. Int. J. Clin. Pharmacol. Ther. 2009; 47 (7): 460–468.
14. LopezCampos J.L., Calero C., LopezRamirez C. et al. Patientreported outcomes and considerations in the management of COPD: focus on aclidinium. Patient Preference and Adherence. 2015; 9: 95–104.
15. Schmid K., Pascaual S., Garcia Gil. E. et al. Pharma cokinetics and safety of aclidinium bromide, a muscarinic antagonist, in adults with normal or impaired renal function: a phase I, openlabeled, singledose clinical trial. Clin. Ther. 2010; 32 (10): 1798–1812.
16. Sun S.X., Mocarski M., Dixit S. et al. Prevalence of renal impairment in COPD patients treated with aclidinium bromide or tiotropium bromide. 10.1164./arjccmconfer ence.2015.191.1._Meeting Abstracts. A5740.
17. Авдеев С.Н. Базисный препарат для терапии хронической обструктивной болезни легких. Consilium Medicum. 2011; 13 (3): 15–20.
18. Kerwin E.M., D`Urzo A.D., Gelb A.F. et al. ACCORD I study investigators. Efficacy and safety of 12week treatment with twicedaily aclidinium bromide in COPD patients (ACCORD COPD I). COPD. 2012; 9 (2): 90–101.
19. Jones P.W., Singh D. Bateman E.D. et al. Efficacy and safety of treatment with twicedaily aclidinium bromide in COPD patients: the ATTAIN study. Eur. Respir. J. 2012; 40: 830–836.
20. Rennard S.I., Scanlon P.D., Ferguson G.T. et al. ACCORD COPD II: a randomized clinical trial to evaluate the 12week efficacy and safety of twicedaily aclidinium bromide in chromic obstructive pulmonary disease patients. Clin. Drug Invest. 2013; 33 (12): 893–904.
21. Gelb A. Tashkin D.P. Make B.J. et al. Longterm safety and efficacy of twicedaily aclidinium bromide in patients with COPD. Respir. Med. 2013; 197 (12): 1957–1965.
22. D`Urzo A., Kerwin E., Rennard S. et al. Oneyear extension study of ACCORD COPD I: safety and efficacy of two doses of twicedaily aclidinium bromide in patients with COPD. COPD. 2013; 10 (4): 500–510.
23. Verkindre C., Fukuchi Y., Flemale A. et al. Sustained 24h efficacy of NVA237, a oncedaily longacting muscarinic antagonists, in COPD patients. Respir. Med. 2010; 104 (10): 1482–1489.
24. Kerwin E.M., Jones P.W., D`Urzo A.D. et al. Efficacy of twicedaily aclidinium bromide 400 mg in subgroups of patients with COPD. Am. J. Crit. Care Med. 2013; 187.1. A4265.
25. Watz H., Beeh K.M., 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.
26. Santus P., Radovanovic D., Marco F.D. et al. Acute effect of aclidinium bromide on hyperinflation and lung volume distribution in patients with severe COPD. 10.1164./arjccmconference.2015.191.1._Meeting Abstracts. A5736.
27. Beeh K.M., Watz H., PuenteMastu L. et al. Aclidinium improves exercise endurance, dyspnea, lung hyperinflation and physical activity in patients with COPD: a randomized, placebocontrolled, crossover trial. BMC Pulm. Med. 2014; 14: 209–221.
28. Maltais F., Celli B., C`asaburi R. et al. Aclidinium bromide improves exercise endurance and lung hyperinflation in patients with moderate to severe COPD. Respir. Med. 2011; 105: 580–587.
29. McGarvey L., Morice A., Smith J. et al. The effect of twice daily aclidinium bromide on cough and sputum in patients with COPD: results from phase III studies Eur. Respir. J. 2014; 44: 920.
30. Cortijo J., Mata M., Milara J. et al. Aclidinium inhibits cholinergic and tobacco smokeinduced MUC5AC in human airways. Eur. Respir. J. 2011; 37: 244–254.
31. Beier J., Kirsten A.M., Mroz R. et al. Efficacy and safety of Aclidinium bromide compared with placebo and Tiotropium in patients with moderate – to – severechronic obstructive pulmonary disease: results from a 6week randomized controlled phase IIIb study. COPD. 2013; 10 (4): 511–522.
32. Partidge M.R., Karlsson N., Small I.R. Patient insight into the impact of chronic obstructive pulmonary disease in the morning: an internet survey. Curr. Med. Res. Opin. 2009; 25: 2043–2048.
33. Higgins V., Broomfield S., Pollard R. et al. Impact of morning symptoms on the working lives of COPD patients. Birmingham, UK: International Conference of Chronic Obstructive Pulmonary Disease. 2012. Abstract.
34. Small M., Broomfield S., Pollard R. et al. Impact of morning symptoms experienced by COPD patients on exacerbation risk, rescue inhaler usage and normal daily activities. Eur. Respir. J. 2012; 40 (56): 3476.
35. Omachi T.A., Blanc P.D., Claman D.M. et al. Disturbed sleep among COPD patients is longitudinally associated with mortality and adverse COPD outcomes. Sleep Med. 2012; 13 (5): 476–483.
36. Fuhr R., Magnussen H., Sarem K. et al. Efficacy and safety of aclidinium bromide 400 mg twice daily compared with placebo and tiotripium in patients with moderatetosevere COPD. Chest. 2012; 141: 745–752.
37. Marth K., Schuller E., Pohl W. Improvements in patient reported outcomes: a prospective, noninterventional study with aclidinium bromide for treatment of COPD. Respir. Med. 2015; 109: 616–624.
38. Roche N., Chavannes N.H., Miravitlles M. COPD symptoms in the morning: impact, evaluation and management. Respir. Res. 2013; 14: 112–119.
39. Joos G.F., Schelfhout V.J., Pauwels R.A. et al. Bronchodilatory effects of aclidinium bromide, a longacting muscarinic antagonist, in COPD patients. Respir. Med. 2010; 104 (6): 865–872.
40. Jones P.W., Rennard S.I., Agusti A. et al. Efficacy and safety of oncedaily aclidinium in chronic obstructive pulmonary disease. Respir. Res. 2011; 12: 55.
41. Kew K.M., Dias S., Cates C.J. Longacting inhaled therapy (betaagonists, anticholinergics and steroids) for COPD: a network metaanalysis. Cochrane Database Syst. Rev. 2014. DOI: 10.1002/14651858.CD010844.pub2.
42. Mroz R.M., Pilar Ausin M., Lamarca R. et al. Effect of aclidinium bromide on dyspnoea and health status in patients with stable COPD: Phase III data by GOLD 2013 classification. Eur. Respir. J. 2014; 44: 891.
43. Моисеев С.В. Бронходилататоры при ХОБЛ: длительно действующие антихолинергические препараты или агонисты β2адренорецепторов? Клиническая фармакология и терапия. 2011; 20 (5): 8–10.
44. Jones P. Aclidinium bromide twice daily for the treatment of chronic obstructive pulmonary disease: a review. Adv. Ther. 2013; 30 (4): 354–368.
45. Wedzicha J.A., Donaldson G., Chuecos F. et al. Effect of aclidinium bromide on exacerbations in patients with moderate – to severe COPD: pooled analysis of phase III studies. Eur. Respir. J. 2014; 44: 1888.
46. Oba Y., Lone A.L. Comparative efficacy of longacting musacarinic antagonists in preventing COPD exacebations: a network metaanalysis and metaregression. Ther. Adv. Respir. Dis. 2015; 9 (1): 3–15.
47. Karabis A., Mocarski M., Eljgelhoven I. et al. Economic evaluation of aclidinium bromide in the management of moderate to severe COPD: an analysis over 5 years. Clin. Econom. Outcom. Res. 2014; 6: 175–185.
48. Lambers C., Hostettler K., Miglino N. et al. Aclidinium bromide reduces epithelialmesenchymal transition of human COPD epithelial cells. Eur. Respir. J. 2013; 42: 253.
49. Lambers C., Qi Y., Papakonstantinou E. et al. Aclidinium bromide reduces extracellular matrix deposition by COPD derived mesenchymal cells. Eur. Respir. J. 2013; 42: 3036.
50. Milara J., Serrano A., Peiro T. et al. Aclidinium inhibits cigarette smokeinduced lung fibroblasttomyofibroblast transition. Eur. Respir. J. 2013; 41: 1264–1274.
51. Milara J., Peiro T., Peiro T. et al. Effects of aclidinium on cigarette smokeinduced fibroblast activation in vitro. Eur. Respir. J. 2011; 38 (55): 851.
52. DominguezFandos D., Ferrer E., PuigPey R. et al. Effects of aclidinium bromide in a cigarette smokeexposed Guinea pig model of chronic obstructive pulmonary disease. Am. J. Respir. Cell Mol. Biol. 2014; 50 (2): 337–346.
53. Jones P.W. Clinical potential of aclidinium bromide in chronic obstructive pulmonary disease. Intern. J. COPD. 2015; 10: 677–687.
54. Newman S.P., Sutton D.J., Segarra R. et al. Lung deposition of aclidinium bromide from Genuair, a multidose drypowder inhaler. Respiration. 2009; 78 (3): 322–328.
55. Block K., Fyrnys B. Impact of different inhalation volumes on the aerodynamics of aclidinium bromide delivered through the Genuair® inhaler. Am. J. Crit. Care Med. 2010; 181: A4467.
56. Leidy N.K., Wilcox T.K., Jones P.W. et al. EXACTPRO Study Group. Standardizing measurement of chronic obstructive pulmonary disease exacerbations: reliability and validity of a patientreported diary. Am. J. Resp. Crit. Care Med. 2011; 183 (3): 323–329.
57. van der Palen J., Ginko T., Kroker A. et al. Preference, satisfaction and errors with two dry powder inhalers in patients with COPD. Exp. Opin. Drug Deliv. 2013; 10 (8): 1023–1031.
58. Donohue J., Rennard S., Celli B. et al. Safety and tolerability of aclidinium bromide in patients with COPD: pooled results from longterm phase III studies. Chest. 2012; 142 (4): 688A.
59. Lasseter K.C., Aubets J., Chuecos F. et al. Aclidinium bromide, a longacting antimuscarinic, does not affect QT interval in healthy subjects. J. Clin. Pharmacol. 2010; 51 (6): 923–932.
60. Chapman K.R., Beck E., Alcaide D. et al. Overall and cardiovascular safety of aclidinium bromide in patients with COPD: results of a pooled analysis. Eur. Respir. J. 2014; 44: 893.
Рецензия
Для цитирования:
Авдеев С.Н., Трушенко Н.В. Новые перспективы в лечении хронической обструктивной болезни легких: в фокусе – аклидиния бромид. Пульмонология. 2015;25(6):725-735. https://doi.org/10.18093/0869-0189-2015-25-6-725-735
For citation:
Avdeev S.N., Trushenko N.V. New perspectives in therapy of chronic obstructive pulmonary disease: revolving around aclidinium bromide. PULMONOLOGIYA. 2015;25(6):725-735. (In Russ.) https://doi.org/10.18093/0869-0189-2015-25-6-725-735
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