Антихолинергические препараты в лечении хронической обструктивной болезни легких: фокус на тиотропий
Аннотация
В последние несколько лет наблюдается лавинообразный рост числа новых лекарственных препаратов и их комбинаций, предлагаемых для лечения больных хронической обструктивной болезнью легких (ХОБЛ), что, с одной стороны, увеличивает терапевтические возможности, с другой – затрудняет выбор лучших из имеющихся. До настоящего времени бронходилататоры остаются ведущим направлением фармакотерапии ХОБЛ, а монотерапия антихолинергическими препаратами (АХП) или их комбинация с другими лекарственными средствами (β2-агонисты длительного действия, глюкокортикоиды, рофлумиласт) – едва ли не наиболее востребованный лечебный подход у данной категории больных. Подобное утверждение базируется главным образом на беспримерных доказательствах эффективности и безопасности применения тиотропия бромида (ТБ) – прототипа длительно действующих АХП, опыт успешного клинического применения которого составляет свыше 10 лет. Во многом именно репутацией ТБ стимулирован результативный поиск других длительно действующих АХП, которые в настоящее время являются одним из наиболее активно разрабатываемых и высокоэффективных классов лекарственных препаратов для лечения ХОБЛ. Очевидно, что у новых АХП база данных по оценке их клинической эффективности и безопасности ограничена, представлена исследованиями III фазы и потому не отражает в полной мере реальную популяцию больных ХОБЛ и не позволяет рассматривать их в качестве безусловной альтернативы ТБ.
Об авторе
А. И. Синопальников
ГБОУ ДПО "Российская медицинская академия последипломного образования" Минздрава России: 123995, Москва, ул. Баррикадная, 2 / 1
Россия
Россия
д. м. н., профессор, зав. кафедрой пульмонологии ГБОУ ДПО "Российская медицинская академия последипломного образования" Минздрава России; тел.: (495) 263-53-72
Список литературы
1. Atsou K., Chouaid C., Hejblum G. Variability of the chronic obstructive pulmonary disease key epidemiological data in Europe; systematic review. BMC Med. 2011; 9: 7–16. http://www.biomedcentral.com/1741-7015/9/7
2. Buist A.S., Vollmer W.M., McBumie M.A. Worldwide burden of COPD in highand low-income countries. Part I. The burden of obstructive lung disease (BOLD) initiative. Int. J. Tuberc. Lung Dis. 2008; 12: 703–708.
3. Menezes A.M., Perez-Padilla R., Hallal P.C. et al. Worldwide burden of COPD in highand low-income countries. Part II. Burden of chronic obstructive lung disease in Latin America: the PLATINO study. Int. J. Tuberc. Lung Dis. 2008; 12: 709–712.
4. http://www.internationalcod.org
5. Chuchalin A.G., Khaltaev N., Antonov N.S. et al. Chronic respiratory diseases and risk factors in 12 regions of the Russian Federation. Int. J. COPD. 2014; 12: 963–974.
6. Aisanov Z., Bai C., Bauerle O. et al. Primary care physician perceptions on the diagnosis and management of chronic obstructive pulmonary disease in diverse regions of the world. Int. J. COPD. 2012; 7: 1–12.
7. O'Donnell D.E., Aaron S., Bourbeau J. et al. Canadian Thoracic Society recommendations for management of chronic obstructive pulmonary disease – 2007. Can. Respir. J. 2007; 14 (Suppl. B): 5B–32B.
8. Qaseem A., Wilt T.J., Weinberger S.E. et al. Diagnosis and management of stable chronic obstructive pulmonary disease: a clinical practice guideline update from the American College of Physicians, American College of Chest Physicians, American Thoracic Society, and European Respiratory Society. Ann. Intern. Med. 2011; 155: 179–191.
9. Broncopneumopatia cronica ostruttiva. Linee guida nazionali di riferimento er la prevenzione e la terapia. http:// www.agenas.it/images/agenas/pnlg/BPCO.pdf
10. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease (Updated 2014). http://www.goldcopd.com/uploads/users/ files/GOLD_Report_2014_Oct30.pdf
11. Чучалин А.Г., Авдеев С.Н., Айсанов З.Р. и др. Федеральные клинические рекомендации по диагностике и лечению хронической обструктивной болезни легких. Пульмонология. 2014; 3: 15–54. / Chuchalin A.G., Avdeev S.N., Aysanov Z.R. et al. Federal guidelines on diagnosis and management of chronic obstructive pulmonary disease. Pul'monologiya. 2014; 3: 15–54 (in Russian).
12. Ohar J.A., Donohue J.F. Monoand combination theray of long-acting bronchodilators and inhaled corticosteroids in advanced COPD. Semin. Resir. Crit. Care Med. 2010; 31: 321–333.
13. Johnson M., Rennard S. Alternative mechanisms for longacting beta(2)-adrenergic agonists in COPD. Chest. 2001; 120: 258–270.
14. Hanania N.A., Moore R.H. Anti-inflammatory activities of beta2-agonists. Cur. Drug Targets Inflam. Allergy. 2004; 3: 271–277.
15. Bennett W.D., Almond M.A., Zeman K.L. et al. Effect of salmeterol on mucociliary and cough clearance in chronic bronchitis. Pulm. Pharmacol. Ther. 2006; 19: 96–100.
16. Profita M., Giorgi R.D., Sala A. et al. Muscarinic receptors, leukotriene B4 production and neutrophilic inflammation in COPD patients. Allergy. 2005; 60: 1361–1369.
17. CG101 chronic obstructive pulmonary disease (update): full guideline. London: National Institute for Health and Clinical Excellence; 2010. http://guidance.nice.org.uk/ CG101/Guidance
18. Vogelmeier C., Hederer B., Glaab T. et al. Tiotropium versus salmeterol for the prevention of exacerbations of COPD. N. Engl. J. Med. 2011; 364: 1093–1103.
19. Chong J., Karner C., Poole P. Tiotropium versus long-acting beta-agonists for stable chronic obstructive pulmonary disease. Cochrane Database Syst. Rev. 2012; 9: CD009157.
20. Kesten S., Jara M., Wentworth C., Lanes S. Pooled clinical trial analysis of tiotropium safety. Chest. 2006; 130: 1695–1703.
21. Kesten S., Celli B., Decramer M. et al. Tiotropium HandiHaler in the treatment of COPD: a safety review. Int. J. Chron. Obstruct. Pulm. Dis. 2009; 4: 397–409.
22. Toy E.L., Beaulieu N.U., McHale J.M. et al. Treatment of COPD: relationships between daily dosing frequency, adherence, resource, and cost. Respir. Med. 2011; 105: 435–441.
23. Gandevia B. Historical review of the use of parasympatholytic agents in the treatment of respiratory disorders. Postgrad Med. J. 1975; 51 (Suppl. 7): 13–20.
24. Jackson M. "Divine stramonium": the rise and fall of smoking for asthma. Med. Hist. 2010; 54: 171–194.
25. Cazzola M., Page C.P., Calzetta L., Matera M.G. Pharmacology and therapeutics of bronchodilators. Pharmacol. Rev. 2012; 64: 450–504.
26. Simons F.E. Anticholinergic drugs and the airways: "time future contained in time past". J. Allergy Clin. Immunol. 1987; 80: 239–242.
27. Restrepo R.D. Use of inhaled anticholinergic agents in obstructive airway disease. Respir. Care. 2007; 52: 833–851.
28. Barnes P.J. The pharmacological properties of tiotropium. Chest. 2000; 117 (2, Suppl.): 63S–66S.
29. Littner M.R., Ilowite J.S., Tashkin D.P. et al. Long acting bronchodilation with once daily dosing of tiotropium (Spiriva) in stable chronic obstructive disease. Am. J. Respir. Crit. Care Med. 2000; 161: 1136–1142.
30. Gross N.J., Co E., Skorodin M.S. Cholinergic bronchomotor tone in COPD. Estimates of its amount in comparison with that in normal subjects. Chest. 1989; 96: 984–987.
31. Gross N.J., Skorodin M.S. Role of the parasympathetic system in airway obstruction due to emphysema. N. Engl. J. Med. 1984; 311: 421–425.
32. Meurs H., Dekkers B.G., Maarsingh H. et al. Muscarinic receptors on airway mesenchymal cells: novel findings for an ancient target. Pulm. Pharmacol. Ther. 2013; 26: 145–155.
33. Cazzola M., Molimard M. The scientific rationale for combining long-acting β2-agonists and muscarinic antagonists in COPD. Pulm. Pharmacol. Ther. 2013; 23: 257–267.
34. Nardini S., Camiciottoli G., Locicero S. et al. COPD: maximization of bronchodilation. Multidiscip. Respir. Med. 2014; 9: 50–60.
35. Sykes D.A., Dowling M.R., Leighton-Devies J. et al. The influence of receptor kinetics on the onset and duration of action and the therapeutic index of NVA237 and tiotropium. J. Pharmacol. Exp. Ther. 2012; 343: 520–528.
36. Disse B., Reichl R., Seck G. et al. Ba 679 BR, a novel longacting anticholinergic bronchodilator. Life Sci. 1993; 52: 537–544.
37. Casarosa P., Bouyssou T., Germeyer S. et al. Preclinical evaluation of long-acting muscarinic antagonists: comparison of tiotropium and investigational drugs. J. Harmacol. Exp. Ther. 2009; 330: 660–668.
38. Haddad E.B., Patel H., Keeling J.E. et al. Pharmacological characterization of the muscarinic recetor anagonists, glycopyrrolate, in human and guinea-pig airways. Br. J. Pharmacol. 1999; 127: 413–420.
39. Singh D., Leaker B., Tutuneu A. Efficacy and safety of nebulized glycopyrrolate (EP-101) for administration using high efficiency nebulizer in patients with COPD (Abstract). Eur. Respir. J. 2011; 38: 147s.
40. Verkindre C., Fucuchi Y., Flemale A. et al. Sustained 24-h efficacy of NVA237, a once-daily long-acting muscarinic antagonist, in COPD patients. Respir. Med. 2010; 104: 1482–1489.
41. Breekveldt-Postma N.S., Koerselman J., Erkens J.A. et al. Enhanced persistence with tiotropium compared with other respiratory drugs in COPD. Respir. Med. 2007; 101: 1398–1405.
42. Cramer J.A., Bradley-Kennedy C., Scalera A. Treatment persistence and compliance with medications for chronic obstructive pulmonary disease. Can. Respir. J. 2007; 14: 25–29.
43. Beeh K.M., Beier J. The short, the long, and the "ultralong": why duration of bronchodilator action matters in chronic obstructive pulmonary disease. Adv. Ther. 2010; 27: 150–159.
44. Taube C., Lehnigk B., Paasch K. et al. Factor analysis of changes in dyspnae and lung function parameters after bronchodilation in chronic obstructive pulmonary disease. Am. J. Respir. Crit. Care Med. 2000; 162: 216–220.
45. Casaburi R., Mahler D.A., Jones P.W. et al. A long-term evaluation of once-daily inhaled tiotropium in chronic obstructive pulmonary disease. Eur. Respir. J. 2002; 19: 217–224.
46. O'Donnell D.E., Voduc N., Fitzpatrick M., Webb K.A. Effect of salmeterol on the ventilator response to exercise in chronic obstructive pulmonary disease. Eur. Respir. J. 2004; 24: 86–94.
47. Anzueto A., Tashkin D., Menjoge S., Kesten S. One-year analysis of longitudinal changes in spirometry in patients with COPD receiving tiotropium. Pulm. Pharmacol. Ther. 2005; 18: 75–81.
48. Vincken W., van Noord J.A., Greefhorst A.P. et al. Dutch / Belgian Tiotropium Study Group. Improved health outcomes in patients with COPD during 1 yr's treatment with tiotropium. Eur. Respir. J. 2002; 19: 209–216.
49. Gauhar U., Dransfield M., Cooper J.A. Sequential comparison of tiotropium to high-dose ipratropium in patients with chronic obstructive pulmonary disease in a practice setting. Int. J. Chron. Obstruct. Pulm. Dis. 2009; 4: 391–395.
50. Niewoehner D.E., Rice K., Cote C. et al. Prevention of exacerbations of chronic obstructive pulmonary disease with tiotropium, a once-daily inhaled anticholinergic bronchodilator: a randomized trial. Ann. Intern. Med. 2005; 143: 317–326.
51. Donohue J.F., van Noord J.A., Bateman E.D. et al. A 6-month, placebo-controlled study comparing lung function and health status changes in COPD patients treated with tiotropium or salmeterol. Chest. 2002; 122: 47–55.
52. Brusasco V., Hodder R., Miravitlles M. et al. Health outcomes following treatment for six months with once daily tiotropium compared with twice daily salmeterol in patients with COPD. Thorax. 2003; 58: 399–404.
53. Briggs D.D. Jr, Covelli H., Lapidus R. et al. Improved daytime spirometric efficacy of tiotropium compared with salmeterol in patients with COPD. Pulm. Pharmacol. Ther. 2005; 18: 397–404.
54. Rodrigo G.J., Nannini L.J., Rodriguez-Roisin R. Safety of long-acting beta-agonists in stable COPD: a systematic review. Chest. 2008; 133: 1079–1087.
55. Tashkin D.P., Celli B., Senn S. et al. for UPLIFT Study Investigators. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N. Engl. J. Med. 2008; 359: 1543–1554.
56. Anzueto A., Miravitlles M. Efficacy of tiotropium in the prevention of exacerbations of COPD. Ther. Adv. Respir. Dis. 2009; 3: 103–111.
57. Celli B., Decramer M., Kesten S. et al. Mortality in the 4-year of tiotropium (UPLIFT) in patients with chronic obstructive pulmonary disease. Am. J. Respir. Crit. Care Med. 2009; 15: 948–955.
58. Gershon A.S., Wang L., To T. et al. Survival with tiotropium compared to long-acting beta-2-agonists in chronic obstructive pulmonary disease. COPD. 2008; 4: 229–234.
59. Burgel P.-R., Paillasseur J.-L., Dusser D. et al. Tiotropium might improve survival in subjects with COPD at high risk of mortality. Respir. Res. 2014; 15 (64): 1–10.
60. Cazzola M., Molimard M. The scientific rationale for combining long-acting beta-2-agonists and muscarinic antagonists in COPD. Pulm. Pharmacol. Ther. 2010; 23: 257–267.
61. COMBIVENT Inhalation Aerosol Study Group. In chronic obstructive pulmonary disease, a combination of ipratropium and albuterol is more effective than either agent alone. A 85-day multicenter trial. Chest. 1994; 105: 1411–1419.
62. van Nord J.A., de Munck D.R., Bantje T.A. et al. Longterm treatment of chronic obstructive pulmonary disease with salmeterol and the additive effect of ipratropium. Eur. Respir. J. 2000; 15: 878–885.
63. Cazzola M., Tashkin D.P. Combination of formoterol and tiotropium in the treatment of COPD: effects on lung function. COPD. 2009; 6: 404–415.
64. 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: 101–108.
65. Mahler D.A., D'Urzo A., Bateman E.D. et al. Concurrent use of indacaterol plus tiotropium in patients with COPD provides superior bronchodilation compared with tiotropium alone: a randomized, double-blind comparison. Thorax. 2012; 67: 781–788.
66. Matera M.G., Rogliani P., Cazzola M. Muscarinic receptor antagonists for the treatment of chronic obstructive pulmonary disease. Exp. Opin. Pharmacother. 2014; 15: 961–977.
67. Aalbers R., Maleki-Yazdi M.R., Hamilton A. et al. Dosefinding study for tiotropium and olodaterol when administration in combination via Resimat inhaler in patients with COPD [abstract]. Eur. Respir. J. 2012; 40: 525–526s.
68. Johnson M. Corticosteroids: potential beta2-agonist and anticholinergic interactions in chronic obstructive pulmonary disease. Proc. Am. Thorac. Soc. 2005; 2: 320–325; discussion 340–341.
69. Singh D., Brooks J., Hagan G. et al. Superiority of "triple" therapy with salmeterol / fluticasone propionate and tiotropium bromide versus in individual components in moderate to severe COPD. Thorax. 2008; 63: 592–598.
70. Perng D.W., Wu C.C., Su K.C. et al. Additive benefits of tiotropium in COPD patients treated with long-acting beta agonists and corticosteroids. Respirology. 2006; 11: 598–602.
71. Aaron S.D., Vandemheen K.L., Fergusson D. et al. Canadian Thoracic Society / Canadian Respiratory Clinical Research Consortium. Tiotropium in combination with placebo, salmeterol, or fluticasone-salmeterol for treatment of chronic obstructive pulmonary disease: a randomized trial. Ann. Intern. Med. 2007; 146: 545–555.
72. Lee T.A., Wilke C., Joo M. et al. Outcomes associated with tiotropium use in patients with chronic obstructive pulmonary disease. Arch. Intern. Med. 2009; 169: 1403–1410.
73. Rodrigo G.J., Plaza V., Casto-Rodriguez J.A. Comparison of three combined pharmacological approaches with tiotropium monotherapy in stable moderate to severe COPD: a systematic review. Ulm. Pharmacol. Ther. 2012; 25: 40–47.
74. Fabbri L.M., Calverley P.M., Izquierdo-Alonso J.L. et al. Roflumilast in moderate-to-severe chronic obstructive pulmonary disease treated with long acting bronchodilators: two randomized clinical trials. Lancet. 2009; 374: 695–703.
75. Sun S.X., Marynchenko M., Banerjee R. et al. Cost-effectiveness analysis of roflumilast / tiotropium therapy versus tiotropium monotherapy for treating severe-to-very severe COPD. J. Med. Econ. 2011; 14: 805–815.
76. Michele T.M., Pinheiro S., Iyasu S. The safety of tiotropium – the FDA's conclusions. N. Engl. J. Med. 2010; 363: 1097–1099.
77. Singh S., Loke Y.K., Enright P.L. et al. Mortality associated with tiotropium mist inhaler in patients with chronic obstructive pulmonary disease: systematic review and metaanalysis of randomized controlled trials. Br. Med. J. 2011; 342: d3215.1–9.
78. Verhamme K., Afonso A., Romio S. et al. Use of tiotropium Respimat SMI versus tiotropium HandiHaler and mortality in patients with COPD. Eur. Respir. J. 2013; 42: 606–615.
79. Jenkins C.R., Beasley R. Tiotropium Respimat increases the risk of mortality. Thorax. 2013; 68: 5–7.
80. Wise R.A., Anzueto A., Cotton D. et al. Tiotropium Respimat inhaler and risk of death in COPD. N. Engl. J. Med. 2013; 369: 1491–1501.
81. Barnes N.C., Jones P.W., Davis K.J. Safety of tiotropium through the Handihaler: why did meta-analyses and database studies appear to give a false alarm? Thorax. 2014; 69: 598–599.
82. Yohanes A.M., Connoly M., Hanania N.A. Ten years of tiotropium: clinical impact and patient perspectives. Intern. J. COPD. 2013; 8: 117–125.
83. Dusser D., Bravo M.L., Iacono P. The effect of tiotropium on exacerbations and airflow in patients with COPD. Eur. Respir. J. 2006; 27: 547–555.
84. Powrie D.J., Wilkinson T.M., Donaldson G.C. et al. Effect of tiotropium on sputum and serum inflammatory markers and exacerbations in COPD. Eur. Resir. J. 2007; 30: 472–478.
85. Tonnel A.B., Perez T., Grosbois J.M. et al. Effect of tiotropium on health-related quality of life as a primary efficacy endpoint in COPD. Int. J. COPD. 2008; 3: 301–310.
86. Reid D.J., Carlson A.A. Clinical use of aclidinium in patients with COPD. Intern. J. COPD. 2014; 9: 369–379.
87. Donohue J.F., Niewoehner D., Brooks J. et al. Safety and tolerability of once-daily umeclidinium / vilanterol 125 / 25 mcg and umeclidinium 125 mcg in patients with chronic obstructive pulmonary disease: results from a 52-week, randomized, double-blind, placebo-controlled study. Respir. Res. 2014; 15: 78–86.
88. Kerwin E.M., D'Urzo A.D., Gelb A.F. et al. Efficacy and safety of a 12-week treatment with twice-daily aclidinium bromide in COPD patients (ACCORD COPD I). COPD. 2012; 9: 90–101.
89. Jones P.W., Singh D., Bateman E.D. et al. Efficacy and safety of twice-daily aclidinium bromide in COPD patients: the ATTAIN study. Eur. Respir. J. 2012; 40: 830–836.
90. D'Urzo A.D., Ferguson G.T., van Noord J.A. et al. Efficacy and safety of once-daily NVA237 in patients with moderateto-severe COPD: the GLOW1 trial. Respir. Res. 2011; 12: 156–163.
Для цитирования:
Синопальников А.И. Антихолинергические препараты в лечении хронической обструктивной болезни легких: фокус на тиотропий. Пульмонология. 2014;(6):73-82. https://doi.org/10.18093/0869-0189-2014-0-6-73-82
For citation:
Sinopal'nikov A.I. Anticholinergics for therapy of chronic obstructive pulmonary disease: focus on tiotropium. Russian Pulmonology. 2014;(6):73-82. (In Russ.) https://doi.org/10.18093/0869-0189-2014-0-6-73-82
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