Место фиксированной комбинации бронходилататоров длительного действия тиотропий / олодатерол в стартовой терапии хронической обструктивной болезни легких. Заключение Совета экспертов Российского респираторного общества

1. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for di-agnosis, management, and prevention of chronic obstructive pulmonary disease. NHLBI / WHO workshop report. Last updated 2016. www.goldcopd.org

2. Miravitlles M., Worth H., Soler Cataluña J.J. et al. Observational study to characterise 24-hour COPD symptoms and their relationship with patient-reported outcomes: results from the ASSESS study. Respir. Res. 2014; 15: 122–127.

3. Lange P., Marott J.L., Vestbo J. et al. Prediction of the clinical course of chronic obstruc-tive pulmonary disease, using the new GOLD classification: a study of the general population. Am. J. Respir. Crit. Care Med. 2012; 186 (10): 976–981.

4. Nishimura К., Izumi T., Tsukino M., Oga T. Dyspnea is a better predictor of 5-year survival than airway obstruction in patients with COPD. Chest. 2002; 121: 1434–1440.

5. Troosters T., Sciurba F., Battaglia S. et al. Physical inactivity in patients with COPD, a controlled multicenter pilot-study. Respir. Med. 2010; 104: 1005−1011.

6. Donaire-Gonzalez D., Gimeno-Santos E., Balcells E. Physical activity in COPD patients: patterns and bouts. Eur. Respir. J. 2013; 42: 993–1002.

7. 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: 331–342.

8. Федеральные клинические рекомендации по диагностике и лечению хронической обструктивной болезни легких. Пульмонология. 2014; 3: 15-61.

9. Lee J.-H., Lee Y.K., Kim E.-K. et al. Responses to inhaled long-acting beta-agonist and corticosteroid according to COPD subtype. Respir. Med. 2010; 104: 542–549.

10. Calverley P., Pauwels R., Vestbo J. et al. Combined salmeterol and fluticasone in the treatment of chronic obstructive pulmonary disease: a randomised controlled trial. Lancet. 2003; 8 (361): 449–456.

11. Vogelmeier C.F., Bateman E.D., Pallante J. et al. Efficacy and safety of once-daily QVA149 compared with twice-daily salmeterol-fluticasone in patients with chronic obstructive pulmonary disease (ILLUMINATE): a randomised, double-blind, parallel group study. Lancet Respir. Med. 2013; 1 (1): 51–60.

12. Burge P.S., Calverley P.M.A., Jones P.W. et al. Randomized, double blind placebo con-trolled study of fluticasone propionate in patients with moderate to severe chronic obstructive pulmonary disease: the ISOLDE-trial. Br. Med. J. 2000; 320 (7245): 1297–1303.

13. Soriano J.B., Sin D.D., Zhang X. et al. A pooled analysis of FEV1 decline in COPD patients randomized to inhaled corticosteroids or placebo. Chest. 2007; 131 (3): 682–689.

14. Wedzicha J.A., Calverley P., Seemunqal T.A. et al. The prevention of chronic obstructive pulmonary disease exacerbations by salmeterol/fluticasone propionate or tiotropium bromide. Am. J. Respir. Crit. Care Med. 2008; 177: 19–26.

15. Wedzicha J.A., Banerji D., Chapman K. R. et al. Indacaterol–glycopyrronium versus salmeterol–fluticasone for COPD.N. Engl. J. Med. 2016; 374 (23): 2222–2234. DOI: 10.1056/NEJMoa1516385.

16. Incalzi R.A., Caradonna P., Ranieri P. et al. Correlates of osteoporosis in chronic obstructive pulmonary disease. Respir. Med. 2000; 94 (11): 1079–1084.

17. Singh S., Amin A.V., Loke Y.K. Long-term use of inhaled corticosteroids and the risk of pneumonia in chronic obstructive pulmonary disease. Arch. Int. Med. 2009; 169: 219–229.

18. Yawn B.P., Li Y., Tian H. et al. Inhaled corticosteroid use in patients with chronic obstructive pulmonary disease and the risk of pneumonia: a retrospective claims data analysis. Int. J. Chron. Obstruct. Pulm. Dis. 2013; 8: 295–304.

19. Lapi F., Kezouh A., Suissa S., Ernst P. The use of inhaled corticosteroids and the risk of adrenal insufficiency. Eur. Respir. J. 2013; 42: 79–86.

20. Tashkin D.P. et al. UPLIFT study investigators. N. Engl. J. Med. 2008; 359: 1543–1554.

21. 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; 9: 963–974.

22. Хроническая обструктивная болезнь легких: профилактика обострений. Клинические рекомендации Американской коллегии торакальных врачей и Канадского торакального общества (часть 1-я). Пульмонология. 2016; 2: 155.

23. Хроническая обструктивная болезнь легких: профилактика обострений. Клинические рекомендации Американской коллегии торакальных врачей и Канадского торакального общества (часть 2-я). Пульмонология. 2016; 3: 170.

24. Decramer M., Celli B., Kesten S. et al. Effect of tiotropium on outcomes in patients with moderate chronic obstructive pulmonary disease (UPLIFT): a prespecied subgroup analysis of a randomised controlled trial. Lancet. 2009; 374: 1171–1178.

25. Wise R.A., Anzueto A., Cotton D. et al. Tiotropium Respimat Inhaler and the Risk of Death in COPD: The TIOSPIR Trial. N. Engl. J. Med. 2013; 369 (10): 1491–501.

26. 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.

27. Bateman E.D., Tashkin D., Siafakas N. et al. A one year trial of tiotropium Respimat® plus usual therapy in COPD patients. Resp. Med. 2010; 104: 1460–1472.

28. Decramer M.L., Chapman K.R., Dahl R. et al. Once-daily indacaterol versus tiotropium for patients with severe chronic obstructive pulmonary disease (INVIGORATE): a randomised, blinded, parallel-group study. Lancet Respir. Med. 2013; 1 (7): 524–533.

29. Frampton J.E. QVA149 (indacaterol/glycopyrronium fixed-dose combination): a review of its use in patients with chronic obstructive pulmonary disease. Drugs. 2014; 74 (4): 465–488.

30. Beeh K.-M., Westerman J., Kirsten A.-M. et al. The 24-h lung function profile of once-daily tiotropium and olodaterol fixed-dose combination in chronic obstructive pulmonary disease. Pulm. Pharmacol. Ther. 2015; 32: 53–59.

31. Buhl R., Maltais F., Abrahams R. et al. Tiotropium and olodaterol fixed-dose combination versus mono-components in COPD (GOLD 2-4). Eur. Respir. J. 2015; 45: 969–979.

32. Ferguson G.T., Flezar M., Korn S. et al. Efficacy of tiotropium + olodaterol in patients with chronic obstructive pulmonary disease by initial disease severity and treatment intensity: a post hoc analysis. Adv. Ther. 2015; 32: 523–536.

33. Singh D., Ferguson G.T., Bolitschek J. et al. Tiotropium + olodaterol shows clinically meaningful improvements in quality of life. Respir. Med. 2015; 109: 1312–1319.

34. Profita M., Bonanno A., Montalbano A.M. et al. β2-Long-acting and anticholinergic drugs control TGF β1-mediated neutrophilic inflammation in COPD. Biochim. Biophys. Acta. 2012; 1822: 1079–1089.

35. Авдеев С.Н. Новые возможности использования тиотропия бромида с помощью аэрозольного устройства доставки – ингалятора Респимат. Пульмонология. 2013; 5: 70–80.

36. Martinez F.J., Abrahams R., Ferguson G.T. et al. Effects of symptom severity at baseline on lung-function and SGRQ responses in the OTEMTO® studies. Am. J. Respir. Crit. Care Med. 2016; 193: A6787.

37. Buhl R., McGarvey L., Korn S. et al. Benefits of tiotropium + olodaterol over tiotropium at delaying clinically significant events in patients with COPD classified as GOLD B. Am. J. Respir. Crit Care Med. 2016; 193: A6779.

38. Singh D., Gaga M., Schmidt O. et al. Effects of tiotropium + olodaterol versus tiotropium or placebo by COPD disease severity and previous treatment history in the OTEMTO® studies. Respir. Res. 2016; 17: 73.

39. Чазова И. Е., Чучалин А. Г., Зыков К. А., Ратова Л. Г. Диагностика и лечение пациентов с артериальной гипертонией и хронической обструктивной болезнью легких (Рекомендации Российского медицинского общества по артериальной гипертонии и Российского респираторного общества). Системные гипертензии. 2013; 10 (1): 5–34.

40. Celli B., Decramer M., Kesten S. et al. Mortality in the 4-year trial of tiotropium (UPLIFT) in patients with chronic obstructive pulmonary disease. Am. J. Respir. Crit. Care Med. 2009; 180: 948–955.

41. Wise R.A., Anzueto A., Cotton D. et al. Tiotropium Respimat inhaler and the risk of death in COPD. N. Engl. J. Med. 2013; 369 (16): 1491–501.

42. Jenkins C.R. More than just reassurance on tiotropium safety. N. Engl. J. Med. 2013; 369 (16): 1555–1556.

43. Cave A.C., Hurst M.M. The use of long acting β2-agonists, alone or in combination with inhaled corticosteroids, in chronic obstructive pulmonary disease (COPD): a risk-benefit analysis. Pharmacol. Ther. 2011; 130: 114–143.

44. Lahousse L., Verhamme K., Stricker B., Brusselle G. Cardiac effects of current treatments of chronic obstructive pulmonary disease. Lancet Respir. Med. 2016; 4: 149–164.