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b2-Агонисты ультрадлительного действия и их роль в терапии хронической обструктивной болезни легких и бронхиальной астмы
b2-Агонисты ультрадлительного действия и их роль в терапии хронической обструктивной болезни легких и бронхиальной астмы
Куценко М.А. b2-Агонисты ультрадлительного действия и их роль в терапии хронической обструктивной болезни легких и бронхиальной астмы. Consilium Medicum. 2016; 18 (3): 47–53. DOI: 10.26442/2075-1753_2016.3.47-53
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Аннотация
b2-Агонисты являются эффективными бронходилататорами за счет непосредственного воздействия на гладкую мускулатуру бронхов. b2-Агонисты короткого действия обеспечивают быстрый эффект для снятия симптомов и кратковременную профилактику бронхоспазма, индуцированного физической нагрузкой или другими триггерами. Важным шагом в повышении комплаентности базисной контролирующей терапии бронхиальной астмы (БА) и хронической обструктивной болезни легких (ХОБЛ) является снижение кратности использования препарата, что получило клиническое подтверждение при применении пролонгированных b2-агонистов, назначаемых 2 раза в день. Создание препаратов нового класса b2-агонистов ультрадлительного действия (24 ч) с быстрым началом действия и приемлемым профилем безопасности открывает новые возможности в лечении БА и ХОБЛ. Их включение в базисную терапию БА и ХОБЛ позволяет добиться лучшего контроля течения этих заболеваний как за счет повышения приверженности пациента назначенной терапии, так и стабильного и длительного бронходилатационного эффекта.
Ключевые слова: b2-агонисты ультрадлительного действия, бронхиальная астма, бронходилататоры, вилантерол, индакатерол, олодатерол, рекомендации, хроническая обструктивная болезнь легких.
Ключевые слова: b2-агонисты ультрадлительного действия, бронхиальная астма, бронходилататоры, вилантерол, индакатерол, олодатерол, рекомендации, хроническая обструктивная болезнь легких.
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b2-Agonists are effective bronchodilators due primarily to their ability to relax airway smooth muscle. Short-acting b2-agonists provide rapid as-needed symptom relief and short-term prophylactic protection against bronchoconstriction induced by exercise or other stimuli. But it was very important to increase compliance of control regimen of bronchial asthma (BA) and chronic obstructive pulmonary disease (COPD) medication. The 12-hours duration showed compliance increasing due to twice administration per day. Creating ultra-long-acting b2-agonists having a rapid onset of effect and acceptable safety profile with once-daily dose administration, is an important strategy to improve adherence and is a regimen preferred by most patients, which may also lead to enhancement of compliance, and may have advantages leading to improved overall clinical outcomes due to long-term and stability bronchodilating effect.
Key words: ultra-long-acting b-agonists b2-agonists, bronchial asthma, bronchodilators, vilanterol, indacaterol, olodaterol, guidelines, chronic obstructive pulmonary disease.
Key words: ultra-long-acting b-agonists b2-agonists, bronchial asthma, bronchodilators, vilanterol, indacaterol, olodaterol, guidelines, chronic obstructive pulmonary disease.
Полный текст
Список литературы
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33. LaForce C, Korenblat P, Osborne P et al. 24-hour bronchodilator efficacy of single doses of indacaterol in patients with persistent asthma: comparison with placebo and formoterol. Curr Med Res Opin 2009; 25: 2353–9.
34. Lee TA, Pickard AS, Au DH et al. Risk for death associated with medications for recently diagnosed chronic obstructive pulmonary disease. Ann Intern Med 2008; 149: 380–90.
35. Lombardi D, Cuenoud B, Kramer SD. Lipid membrane interactions of indacaterol and salmeterol: do they influence their pharmacological properties? Eur J Pharm Sci 2009; 38: 533– 47.
36. Lopez AD, Shibuya K, Rao C et al. Chronic obstructive pulmonary disease: current burden and future projections. Eur Respir J 2006; 27 (2): 397–412.
37. Lotvall J, Bateman ED, Bleecker ER et al. 24h duration of the novel LABA vilanterol trifenatate in asthma patients treated with inhaled corticosteroids. Eur Respir J 2012; 40 (3): 570–9.
38. Masoli M, Fabian D, Holt S, Beasley R. The global burden of asthma: executive summary of the GINA Dissemination Committee report. Allergy 2004; 59: 469–78.
39. Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med 2006; 3: e442.
40. Meurs H. A new perspective on muscarinic receptor antagonism in obstructive airway disease. Curr Opin Pharmacol 2013; 13: 316–23.
41. McIntyre E, Alpers JH, Ruffin RE. Bronchial smooth muscle tone in normal subjects. Chest 1982; 81 (3): 396.
42. McKay SE, Howie CA, Thomson AH et al. Value of theophylline treatment in patients handicapped by chronic obstructive lung disease. Thorax 1993; 48 (3): 227–32.
43. Murciano D, Auclair MH, Pariente R, Aubier M. A randomized, controlled trial of theophylline in patients with severe chronic obstructive pulmonary disease. N Engl J Med 1989; 320 (23): 1521–5.
44. Naline E, Trifilieff A, Fairhurst RA et al. Effect of indacaterol, a novel long acting b2-agonist, on isolated human bronchi. Eur Respir J 2007; 29: 575–81.
45. Pearlman DS, Greos L, LaForce C et al. Bronchodilator efficacy of indacaterol, a novel once-daily beta2-agonist, in patients with persistent asthma. Ann Allergy Asthma Immunol 2008; 101: 90–5.
46. Procopiou PA, Barrett VJ, Bevan NJ et al. Synthesis and structure-activity relationships of long-acting beta2 adrenergic receptor agonists incorporating metabolic inactivation: an antedrug approach. J Med Chem 2010; 53 (11): 4522–30.
47. Rosethorne EM, Turner RJ, Fairhurst RA, Charlton SJ. Efficacy is a contributing factor to the clinical onset of bronchodilation of inhaled b2-adrenoceptor agonists. Naunyn Schmiedebergs Arch Pharmacol 2010; 382: 255–63.
48. Salpenter SR, Buckley NS, Salpenter EE. Meta-analiysis: anticholinergics, but not b2-agonists, reduce severe exacerbations and respiratory mortality in COPD. J Gen Intern Med 2006; 21: 1011–9.
49. Sharpe TR, Mikeal RL. Patient compliance with prescription medication regimens. J Am Pharm Assoc 1975; 15 (4): 191–2.
50. Singh S, Loke YK, Furberg CD. Inhaled anticholinergics and risk of major adverse cardiovascular events in patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis. JAMA 2008; 300: 1439–50.
51. Singh S, Loke YK, Enright PL, Furberg CD. Mortality associated with tiotropium mist inhaler in patients with chronic obstructive pulmonary disease: systematic review and meta-analysis of randomised controlled trials. BMJ 2011; 342: d3215.
52. Singh S, Loke YK, Enright P, Furberg CD. Pro-arrhythmic and pro-ischaemic effects of inhaled anticholinergic medications. Thorax 2013; 68 (1): 114–6.
53. Sturton RG, Trifilieff A, Nicholson AG, Barnes PJ. Pharmacological characterization of indacaterol, a novel once daily inhaled _2 adrenoceptor agonist, on small airways in human and rat precision-cut lung slices. J Pharmacol Exp Ther 2008; 324: 270–5.
54. Sugihara N, Kanada S, Haida M et al. 24-h bronchodilator efficacy of single doses of indacaterol in Japanese patients with asthma: A comparison with placebo and salmeterol. Respir Med 2010; 104: 1629–37.
55. Tashkin DP, Celli B, Senn S et al. UPLIFT Study Investigators. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med 2004; 359: 1543–54.
56. Van den Boom G, Van Schayck CP, Van Mollen MP et al. Active detection of chronic obstructive pulmonary disease and asthma in the general population. Results and economic consequences of the DIMCA program. Am J Respir Crit Care Med 1998; 158: 1730–8.
57. Van Noord JA, Smeets JJ, Drenth BM et al. 24Hour bronchodilation following a single dose of the novel β2agonist olodaterol in COPD. Pulm Pharmacol Ther 2011; 24: 666–72.
58. Yang WH, Martinot JB, Pohunek P et al. Tolerability of indacaterol, a novel once-daily beta2-agonist, in patients with asthma: a randomized, placebo-controlled, 28-day safety study. Ann Allergy Asthma Immunol 2007; 99: 555–61.
59. Zhou Y, Wang X, Zeng X et al. Positive benefits of theophylline in a randomized, double-blind, parallel group, placebo controlled study of low-dose, slow-release theophylline in the treatment of COPD for 1 year. Respirology 2006; 11 (5): 603–10.
3. Battram C, Charlton SJ, Cuenoud B et al. In vitro and in vivo pharmacological characterization of 5-[(R)-2-(5.6-diethyl-indan-2-ylamino)-1-hydroxy-ethyl]-8-hydroxy-1H-quinolin-2-one (indacaterol), a novel inhaled b2-adrenoceptor agonist with a 24-h duration of action. J Pharmacol Exp Ther 2006; 317: 762–70.
4. Bourke D, Warlry A. The steady state and rebreathing methods compared during morphine administration in humans. J Physiol 1989; 419: 509–17.
5. Brookman LJ, Knowles LJ, Barbier M et al. Efficacy and safety of single therapeutic and supratherapeutic doses of indacaterol versus salmeterol and salbutamol in patients with asthma. Curr Med Res Opin 2007; 23: 3113–22.
6. Campbell LM. Once-daily inhaled corticosteroids in mild to moderate asthma: improving acceptance of treatment. Drugs 1999; 58 (Suppl. 4): 25–33.
7. Carstairs JR, Nimmo AJ, Barnes PJ. Autoradiographic visualization of beta-adrenoceptor subtypes in human lung. Am Rev Respir Dis 1985; 132 (3): 541–7.
8. Cazzola M, Page CP, Calzetta L, Matera MG. Pharmacology and Therapeutics of Bronchodilators. Pharmacol Rev 2012; 64: 450–504.
9. Celli B, Benditt J, Albert R. Chronic Obstructive Pulmonary Disease. Comprehensive Respiratory Medicine, edited by R.Albert, S.Sriro, J.J.Mosby. 1999; 37: 1–37.
10. Chowdhury BA, Dal Pan G. The FDA and safe use of long-acting beta-agonists in the treatment of asthma. N Engl J Med 2010; 362 (13): 1169–71.
11. Chuchalin AG, Tsoi AN, Richter K et al. Safety and tolerability of indacaterol in asthma: a randomized, placebo-controlled 28-day study. Respir Med 2007; 101: 2065–75.
12. Cope S, CapkunNiggli G, Gale R et al. Comparative efficacy of indacaterol 150/xg and 300/xg versus fixeddose combinations of formoterol + budesonide or salmeterol + fluticasone for the treatment of chronic obstructive pulmonary disease – a network metaanalysis. Int J Chron Obstruct Pulm Dis 2011; 6: 329–44.
13. Dahl R, Chung KF, Buhl R et al. Efficacy of a new once-daily LABA, indacaterol, versus the twice-daily LABA, formoterol, in COPD. Thorax 2010; 65: 473–9.
14. Donohue JF, Fogarty C, Lotvall J et al. Once-daily bronchodilators for chronic obstructive pulmonary disease: indacaterol versus tiotropium. Am J Respir Crit Care Med 2010; 182: 155–62.
15. Edsbäcker S. Pharmacological factors that influence the choice of inhaled corticosteroids. Drugs 1999; 58 (Suppl. 4):7–16.
16. Feldman G, Siler T, Prasad N et al. INLIGHT 1study group. Efficacy and safety of indacaterol 150 microg once-daily in COPD: a double blind, randomised, 12-week study. BMC Pulm Med 2010; 10: 11.
17. Ferguson GT, Feldman GJ, Hofbauer P et al. Efficacy and safety of olodaterol once daily delivered via RespimatR in patients with GOLD 2–4 COPD: results from two replicate 48-week studies. Int J Chron Obstruct Pulm Dis 2014; 9: 629–45.
18. Fletcher MJ, Upton J, Taylor-Fishwick J et al. COPD uncovered: an international survey on the impact of chronic obstructive pulmonary disease [COPD] on a working age population. BMC Public Health 2011; 11: 612.
19. Gibb A, Yang LP. Olodaterol: first global approval. Drugs 2013; 73 (16): 1841–6.
20. Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease. NHLBI/WHO workshop report updated 2015.
21. Global Strategy for Asthma Management and Prevention (2015 update).
22. Gross NG. Anticholinergic therapy in chronic obstructive pulmonary disease. London: Franclin Scientific, 1993.
23. Guyatt GH Townsend M, Pugsley SO et al. Bronchodilators in chronic airflow limitation. Effects on airway function, exercise capacity, and quality of life. Am Rev Respir Dis 1987; 135 (5): 1069–74.
24. Hanania NA, Feldman G, Zachgo W et al. The efficacy and safety of the novel long-acting b2-agonist vilanterol in patients with COPD: a randomized placebo-controlled trial. Chest 2012; 142 (1): 119–27.
25. Jones TR, Charette L, Garcia ML, Kaczorowski GJ. Selective inhibition of relaxation of guinea-pig trachea by charybdotoxin, a potent Ca++-activated K+-channel inhibitor. J Pharmacol Exp Ther 1990; 255: 697–706.
26. Kanniess F, Boulet LP, Pierzchala W et al. Efficacy and safety of indacaterol, a new 24-h b2-agonist, in patients with asthma: a dose-ranging study. J Asthma 2008; 45: 887–92.
27. Kempsford R, Norris V, Siederer S. Vilanterol trifenatate, a novel inhaled long-acting beta2-adrenoceptor agonist, is well tolerated in healthy subjects and demonstrates prolonged bronchodilation in subjects with asthma and COPD. Pulm Pharmacol Ther 2013; 26 (2): 256–64.
28. Kew KM, Dias S, Cates CJ. Long-acting inhaled therapy (beta-agonists, anticholinergics and steroids) for COPD: a network meta-analysis. Cochrane Database Syst Rev 2014; Issue 3: Art. No.: CD010844. Doi: 10.1002/14651858. CD010844.pub2.
29. Kew KM, Evans DJ, Allison DE, Boyter AC. Long-acting muscarinic antagonists (LAMA) added to inhaled corticosteroids (ICS) versus addition of long-acting beta2-agonists (LABA) for adults with asthma. Cochrane Database Syst Rev 2015; 6: CD011438. Doi: 10.1002/14651858.CD011438.pub2.
30. Kornmann O, Dahl R, Centanni S et al. Once-daily indacaterol vs twice-daily salmeterol for COPD: a placebo controlled comparison. Eur Respir J 2011; 37: 273–9.
31. Kuehn BM. FDA offers advice to reduce risks of long-acting beta-agonists in asthma care. JAMA 2010; 303 (14): 1353–4.
32. LaForce C, Alexander M, Deckelmann R et al. Indacaterol provides sustained 24 h bronchodilation on once-daily dosing in asthma: a 7-day dose-ranging study. Allergy 2008; 63: 103–11.
33. LaForce C, Korenblat P, Osborne P et al. 24-hour bronchodilator efficacy of single doses of indacaterol in patients with persistent asthma: comparison with placebo and formoterol. Curr Med Res Opin 2009; 25: 2353–9.
34. Lee TA, Pickard AS, Au DH et al. Risk for death associated with medications for recently diagnosed chronic obstructive pulmonary disease. Ann Intern Med 2008; 149: 380–90.
35. Lombardi D, Cuenoud B, Kramer SD. Lipid membrane interactions of indacaterol and salmeterol: do they influence their pharmacological properties? Eur J Pharm Sci 2009; 38: 533– 47.
36. Lopez AD, Shibuya K, Rao C et al. Chronic obstructive pulmonary disease: current burden and future projections. Eur Respir J 2006; 27 (2): 397–412.
37. Lotvall J, Bateman ED, Bleecker ER et al. 24h duration of the novel LABA vilanterol trifenatate in asthma patients treated with inhaled corticosteroids. Eur Respir J 2012; 40 (3): 570–9.
38. Masoli M, Fabian D, Holt S, Beasley R. The global burden of asthma: executive summary of the GINA Dissemination Committee report. Allergy 2004; 59: 469–78.
39. Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med 2006; 3: e442.
40. Meurs H. A new perspective on muscarinic receptor antagonism in obstructive airway disease. Curr Opin Pharmacol 2013; 13: 316–23.
41. McIntyre E, Alpers JH, Ruffin RE. Bronchial smooth muscle tone in normal subjects. Chest 1982; 81 (3): 396.
42. McKay SE, Howie CA, Thomson AH et al. Value of theophylline treatment in patients handicapped by chronic obstructive lung disease. Thorax 1993; 48 (3): 227–32.
43. Murciano D, Auclair MH, Pariente R, Aubier M. A randomized, controlled trial of theophylline in patients with severe chronic obstructive pulmonary disease. N Engl J Med 1989; 320 (23): 1521–5.
44. Naline E, Trifilieff A, Fairhurst RA et al. Effect of indacaterol, a novel long acting b2-agonist, on isolated human bronchi. Eur Respir J 2007; 29: 575–81.
45. Pearlman DS, Greos L, LaForce C et al. Bronchodilator efficacy of indacaterol, a novel once-daily beta2-agonist, in patients with persistent asthma. Ann Allergy Asthma Immunol 2008; 101: 90–5.
46. Procopiou PA, Barrett VJ, Bevan NJ et al. Synthesis and structure-activity relationships of long-acting beta2 adrenergic receptor agonists incorporating metabolic inactivation: an antedrug approach. J Med Chem 2010; 53 (11): 4522–30.
47. Rosethorne EM, Turner RJ, Fairhurst RA, Charlton SJ. Efficacy is a contributing factor to the clinical onset of bronchodilation of inhaled b2-adrenoceptor agonists. Naunyn Schmiedebergs Arch Pharmacol 2010; 382: 255–63.
48. Salpenter SR, Buckley NS, Salpenter EE. Meta-analiysis: anticholinergics, but not b2-agonists, reduce severe exacerbations and respiratory mortality in COPD. J Gen Intern Med 2006; 21: 1011–9.
49. Sharpe TR, Mikeal RL. Patient compliance with prescription medication regimens. J Am Pharm Assoc 1975; 15 (4): 191–2.
50. Singh S, Loke YK, Furberg CD. Inhaled anticholinergics and risk of major adverse cardiovascular events in patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis. JAMA 2008; 300: 1439–50.
51. Singh S, Loke YK, Enright PL, Furberg CD. Mortality associated with tiotropium mist inhaler in patients with chronic obstructive pulmonary disease: systematic review and meta-analysis of randomised controlled trials. BMJ 2011; 342: d3215.
52. Singh S, Loke YK, Enright P, Furberg CD. Pro-arrhythmic and pro-ischaemic effects of inhaled anticholinergic medications. Thorax 2013; 68 (1): 114–6.
53. Sturton RG, Trifilieff A, Nicholson AG, Barnes PJ. Pharmacological characterization of indacaterol, a novel once daily inhaled _2 adrenoceptor agonist, on small airways in human and rat precision-cut lung slices. J Pharmacol Exp Ther 2008; 324: 270–5.
54. Sugihara N, Kanada S, Haida M et al. 24-h bronchodilator efficacy of single doses of indacaterol in Japanese patients with asthma: A comparison with placebo and salmeterol. Respir Med 2010; 104: 1629–37.
55. Tashkin DP, Celli B, Senn S et al. UPLIFT Study Investigators. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med 2004; 359: 1543–54.
56. Van den Boom G, Van Schayck CP, Van Mollen MP et al. Active detection of chronic obstructive pulmonary disease and asthma in the general population. Results and economic consequences of the DIMCA program. Am J Respir Crit Care Med 1998; 158: 1730–8.
57. Van Noord JA, Smeets JJ, Drenth BM et al. 24Hour bronchodilation following a single dose of the novel β2agonist olodaterol in COPD. Pulm Pharmacol Ther 2011; 24: 666–72.
58. Yang WH, Martinot JB, Pohunek P et al. Tolerability of indacaterol, a novel once-daily beta2-agonist, in patients with asthma: a randomized, placebo-controlled, 28-day safety study. Ann Allergy Asthma Immunol 2007; 99: 555–61.
59. Zhou Y, Wang X, Zeng X et al. Positive benefits of theophylline in a randomized, double-blind, parallel group, placebo controlled study of low-dose, slow-release theophylline in the treatment of COPD for 1 year. Respirology 2006; 11 (5): 603–10.
2. Barnes PJ, Liu SF. Regulation of pulmonary vascular tone. Pharmacol Rev 1995; 47 (1): 87–131.
3. Battram C, Charlton SJ, Cuenoud B et al. In vitro and in vivo pharmacological characterization of 5-[(R)-2-(5.6-diethyl-indan-2-ylamino)-1-hydroxy-ethyl]-8-hydroxy-1H-quinolin-2-one (indacaterol), a novel inhaled b2-adrenoceptor agonist with a 24-h duration of action. J Pharmacol Exp Ther 2006; 317: 762–70.
4. Bourke D, Warlry A. The steady state and rebreathing methods compared during morphine administration in humans. J Physiol 1989; 419: 509–17.
5. Brookman LJ, Knowles LJ, Barbier M et al. Efficacy and safety of single therapeutic and supratherapeutic doses of indacaterol versus salmeterol and salbutamol in patients with asthma. Curr Med Res Opin 2007; 23: 3113–22.
6. Campbell LM. Once-daily inhaled corticosteroids in mild to moderate asthma: improving acceptance of treatment. Drugs 1999; 58 (Suppl. 4): 25–33.
7. Carstairs JR, Nimmo AJ, Barnes PJ. Autoradiographic visualization of beta-adrenoceptor subtypes in human lung. Am Rev Respir Dis 1985; 132 (3): 541–7.
8. Cazzola M, Page CP, Calzetta L, Matera MG. Pharmacology and Therapeutics of Bronchodilators. Pharmacol Rev 2012; 64: 450–504.
9. Celli B, Benditt J, Albert R. Chronic Obstructive Pulmonary Disease. Comprehensive Respiratory Medicine, edited by R.Albert, S.Sriro, J.J.Mosby. 1999; 37: 1–37.
10. Chowdhury BA, Dal Pan G. The FDA and safe use of long-acting beta-agonists in the treatment of asthma. N Engl J Med 2010; 362 (13): 1169–71.
11. Chuchalin AG, Tsoi AN, Richter K et al. Safety and tolerability of indacaterol in asthma: a randomized, placebo-controlled 28-day study. Respir Med 2007; 101: 2065–75.
12. Cope S, CapkunNiggli G, Gale R et al. Comparative efficacy of indacaterol 150/xg and 300/xg versus fixeddose combinations of formoterol + budesonide or salmeterol + fluticasone for the treatment of chronic obstructive pulmonary disease – a network metaanalysis. Int J Chron Obstruct Pulm Dis 2011; 6: 329–44.
13. Dahl R, Chung KF, Buhl R et al. Efficacy of a new once-daily LABA, indacaterol, versus the twice-daily LABA, formoterol, in COPD. Thorax 2010; 65: 473–9.
14. Donohue JF, Fogarty C, Lotvall J et al. Once-daily bronchodilators for chronic obstructive pulmonary disease: indacaterol versus tiotropium. Am J Respir Crit Care Med 2010; 182: 155–62.
15. Edsbäcker S. Pharmacological factors that influence the choice of inhaled corticosteroids. Drugs 1999; 58 (Suppl. 4):7–16.
16. Feldman G, Siler T, Prasad N et al. INLIGHT 1study group. Efficacy and safety of indacaterol 150 microg once-daily in COPD: a double blind, randomised, 12-week study. BMC Pulm Med 2010; 10: 11.
17. Ferguson GT, Feldman GJ, Hofbauer P et al. Efficacy and safety of olodaterol once daily delivered via RespimatR in patients with GOLD 2–4 COPD: results from two replicate 48-week studies. Int J Chron Obstruct Pulm Dis 2014; 9: 629–45.
18. Fletcher MJ, Upton J, Taylor-Fishwick J et al. COPD uncovered: an international survey on the impact of chronic obstructive pulmonary disease [COPD] on a working age population. BMC Public Health 2011; 11: 612.
19. Gibb A, Yang LP. Olodaterol: first global approval. Drugs 2013; 73 (16): 1841–6.
20. Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease. NHLBI/WHO workshop report updated 2015.
21. Global Strategy for Asthma Management and Prevention (2015 update).
22. Gross NG. Anticholinergic therapy in chronic obstructive pulmonary disease. London: Franclin Scientific, 1993.
23. Guyatt GH Townsend M, Pugsley SO et al. Bronchodilators in chronic airflow limitation. Effects on airway function, exercise capacity, and quality of life. Am Rev Respir Dis 1987; 135 (5): 1069–74.
24. Hanania NA, Feldman G, Zachgo W et al. The efficacy and safety of the novel long-acting b2-agonist vilanterol in patients with COPD: a randomized placebo-controlled trial. Chest 2012; 142 (1): 119–27.
25. Jones TR, Charette L, Garcia ML, Kaczorowski GJ. Selective inhibition of relaxation of guinea-pig trachea by charybdotoxin, a potent Ca++-activated K+-channel inhibitor. J Pharmacol Exp Ther 1990; 255: 697–706.
26. Kanniess F, Boulet LP, Pierzchala W et al. Efficacy and safety of indacaterol, a new 24-h b2-agonist, in patients with asthma: a dose-ranging study. J Asthma 2008; 45: 887–92.
27. Kempsford R, Norris V, Siederer S. Vilanterol trifenatate, a novel inhaled long-acting beta2-adrenoceptor agonist, is well tolerated in healthy subjects and demonstrates prolonged bronchodilation in subjects with asthma and COPD. Pulm Pharmacol Ther 2013; 26 (2): 256–64.
28. Kew KM, Dias S, Cates CJ. Long-acting inhaled therapy (beta-agonists, anticholinergics and steroids) for COPD: a network meta-analysis. Cochrane Database Syst Rev 2014; Issue 3: Art. No.: CD010844. Doi: 10.1002/14651858. CD010844.pub2.
29. Kew KM, Evans DJ, Allison DE, Boyter AC. Long-acting muscarinic antagonists (LAMA) added to inhaled corticosteroids (ICS) versus addition of long-acting beta2-agonists (LABA) for adults with asthma. Cochrane Database Syst Rev 2015; 6: CD011438. Doi: 10.1002/14651858.CD011438.pub2.
30. Kornmann O, Dahl R, Centanni S et al. Once-daily indacaterol vs twice-daily salmeterol for COPD: a placebo controlled comparison. Eur Respir J 2011; 37: 273–9.
31. Kuehn BM. FDA offers advice to reduce risks of long-acting beta-agonists in asthma care. JAMA 2010; 303 (14): 1353–4.
32. LaForce C, Alexander M, Deckelmann R et al. Indacaterol provides sustained 24 h bronchodilation on once-daily dosing in asthma: a 7-day dose-ranging study. Allergy 2008; 63: 103–11.
33. LaForce C, Korenblat P, Osborne P et al. 24-hour bronchodilator efficacy of single doses of indacaterol in patients with persistent asthma: comparison with placebo and formoterol. Curr Med Res Opin 2009; 25: 2353–9.
34. Lee TA, Pickard AS, Au DH et al. Risk for death associated with medications for recently diagnosed chronic obstructive pulmonary disease. Ann Intern Med 2008; 149: 380–90.
35. Lombardi D, Cuenoud B, Kramer SD. Lipid membrane interactions of indacaterol and salmeterol: do they influence their pharmacological properties? Eur J Pharm Sci 2009; 38: 533– 47.
36. Lopez AD, Shibuya K, Rao C et al. Chronic obstructive pulmonary disease: current burden and future projections. Eur Respir J 2006; 27 (2): 397–412.
37. Lotvall J, Bateman ED, Bleecker ER et al. 24h duration of the novel LABA vilanterol trifenatate in asthma patients treated with inhaled corticosteroids. Eur Respir J 2012; 40 (3): 570–9.
38. Masoli M, Fabian D, Holt S, Beasley R. The global burden of asthma: executive summary of the GINA Dissemination Committee report. Allergy 2004; 59: 469–78.
39. Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med 2006; 3: e442.
40. Meurs H. A new perspective on muscarinic receptor antagonism in obstructive airway disease. Curr Opin Pharmacol 2013; 13: 316–23.
41. McIntyre E, Alpers JH, Ruffin RE. Bronchial smooth muscle tone in normal subjects. Chest 1982; 81 (3): 396.
42. McKay SE, Howie CA, Thomson AH et al. Value of theophylline treatment in patients handicapped by chronic obstructive lung disease. Thorax 1993; 48 (3): 227–32.
43. Murciano D, Auclair MH, Pariente R, Aubier M. A randomized, controlled trial of theophylline in patients with severe chronic obstructive pulmonary disease. N Engl J Med 1989; 320 (23): 1521–5.
44. Naline E, Trifilieff A, Fairhurst RA et al. Effect of indacaterol, a novel long acting b2-agonist, on isolated human bronchi. Eur Respir J 2007; 29: 575–81.
45. Pearlman DS, Greos L, LaForce C et al. Bronchodilator efficacy of indacaterol, a novel once-daily beta2-agonist, in patients with persistent asthma. Ann Allergy Asthma Immunol 2008; 101: 90–5.
46. Procopiou PA, Barrett VJ, Bevan NJ et al. Synthesis and structure-activity relationships of long-acting beta2 adrenergic receptor agonists incorporating metabolic inactivation: an antedrug approach. J Med Chem 2010; 53 (11): 4522–30.
47. Rosethorne EM, Turner RJ, Fairhurst RA, Charlton SJ. Efficacy is a contributing factor to the clinical onset of bronchodilation of inhaled b2-adrenoceptor agonists. Naunyn Schmiedebergs Arch Pharmacol 2010; 382: 255–63.
48. Salpenter SR, Buckley NS, Salpenter EE. Meta-analiysis: anticholinergics, but not b2-agonists, reduce severe exacerbations and respiratory mortality in COPD. J Gen Intern Med 2006; 21: 1011–9.
49. Sharpe TR, Mikeal RL. Patient compliance with prescription medication regimens. J Am Pharm Assoc 1975; 15 (4): 191–2.
50. Singh S, Loke YK, Furberg CD. Inhaled anticholinergics and risk of major adverse cardiovascular events in patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis. JAMA 2008; 300: 1439–50.
51. Singh S, Loke YK, Enright PL, Furberg CD. Mortality associated with tiotropium mist inhaler in patients with chronic obstructive pulmonary disease: systematic review and meta-analysis of randomised controlled trials. BMJ 2011; 342: d3215.
52. Singh S, Loke YK, Enright P, Furberg CD. Pro-arrhythmic and pro-ischaemic effects of inhaled anticholinergic medications. Thorax 2013; 68 (1): 114–6.
53. Sturton RG, Trifilieff A, Nicholson AG, Barnes PJ. Pharmacological characterization of indacaterol, a novel once daily inhaled _2 adrenoceptor agonist, on small airways in human and rat precision-cut lung slices. J Pharmacol Exp Ther 2008; 324: 270–5.
54. Sugihara N, Kanada S, Haida M et al. 24-h bronchodilator efficacy of single doses of indacaterol in Japanese patients with asthma: A comparison with placebo and salmeterol. Respir Med 2010; 104: 1629–37.
55. Tashkin DP, Celli B, Senn S et al. UPLIFT Study Investigators. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med 2004; 359: 1543–54.
56. Van den Boom G, Van Schayck CP, Van Mollen MP et al. Active detection of chronic obstructive pulmonary disease and asthma in the general population. Results and economic consequences of the DIMCA program. Am J Respir Crit Care Med 1998; 158: 1730–8.
57. Van Noord JA, Smeets JJ, Drenth BM et al. 24Hour bronchodilation following a single dose of the novel β2agonist olodaterol in COPD. Pulm Pharmacol Ther 2011; 24: 666–72.
58. Yang WH, Martinot JB, Pohunek P et al. Tolerability of indacaterol, a novel once-daily beta2-agonist, in patients with asthma: a randomized, placebo-controlled, 28-day safety study. Ann Allergy Asthma Immunol 2007; 99: 555–61.
59. Zhou Y, Wang X, Zeng X et al. Positive benefits of theophylline in a randomized, double-blind, parallel group, placebo controlled study of low-dose, slow-release theophylline in the treatment of COPD for 1 year. Respirology 2006; 11 (5): 603–10.
________________________________________________
1. Gosudarstvennyi reestr lekarstvennykh sredstv. http://grls.rosminzdrav.ru [in Russian]
2. Barnes PJ, Liu SF. Regulation of pulmonary vascular tone. Pharmacol Rev 1995; 47 (1): 87–131.3. Battram C, Charlton SJ, Cuenoud B et al. In vitro and in vivo pharmacological characterization of 5-[(R)-2-(5.6-diethyl-indan-2-ylamino)-1-hydroxy-ethyl]-8-hydroxy-1H-quinolin-2-one (indacaterol), a novel inhaled b2-adrenoceptor agonist with a 24-h duration of action. J Pharmacol Exp Ther 2006; 317: 762–70.
4. Bourke D, Warlry A. The steady state and rebreathing methods compared during morphine administration in humans. J Physiol 1989; 419: 509–17.
5. Brookman LJ, Knowles LJ, Barbier M et al. Efficacy and safety of single therapeutic and supratherapeutic doses of indacaterol versus salmeterol and salbutamol in patients with asthma. Curr Med Res Opin 2007; 23: 3113–22.
6. Campbell LM. Once-daily inhaled corticosteroids in mild to moderate asthma: improving acceptance of treatment. Drugs 1999; 58 (Suppl. 4): 25–33.
7. Carstairs JR, Nimmo AJ, Barnes PJ. Autoradiographic visualization of beta-adrenoceptor subtypes in human lung. Am Rev Respir Dis 1985; 132 (3): 541–7.
8. Cazzola M, Page CP, Calzetta L, Matera MG. Pharmacology and Therapeutics of Bronchodilators. Pharmacol Rev 2012; 64: 450–504.
9. Celli B, Benditt J, Albert R. Chronic Obstructive Pulmonary Disease. Comprehensive Respiratory Medicine, edited by R.Albert, S.Sriro, J.J.Mosby. 1999; 37: 1–37.
10. Chowdhury BA, Dal Pan G. The FDA and safe use of long-acting beta-agonists in the treatment of asthma. N Engl J Med 2010; 362 (13): 1169–71.
11. Chuchalin AG, Tsoi AN, Richter K et al. Safety and tolerability of indacaterol in asthma: a randomized, placebo-controlled 28-day study. Respir Med 2007; 101: 2065–75.
12. Cope S, CapkunNiggli G, Gale R et al. Comparative efficacy of indacaterol 150/xg and 300/xg versus fixeddose combinations of formoterol + budesonide or salmeterol + fluticasone for the treatment of chronic obstructive pulmonary disease – a network metaanalysis. Int J Chron Obstruct Pulm Dis 2011; 6: 329–44.
13. Dahl R, Chung KF, Buhl R et al. Efficacy of a new once-daily LABA, indacaterol, versus the twice-daily LABA, formoterol, in COPD. Thorax 2010; 65: 473–9.
14. Donohue JF, Fogarty C, Lotvall J et al. Once-daily bronchodilators for chronic obstructive pulmonary disease: indacaterol versus tiotropium. Am J Respir Crit Care Med 2010; 182: 155–62.
15. Edsbäcker S. Pharmacological factors that influence the choice of inhaled corticosteroids. Drugs 1999; 58 (Suppl. 4):7–16.
16. Feldman G, Siler T, Prasad N et al. INLIGHT 1study group. Efficacy and safety of indacaterol 150 microg once-daily in COPD: a double blind, randomised, 12-week study. BMC Pulm Med 2010; 10: 11.
17. Ferguson GT, Feldman GJ, Hofbauer P et al. Efficacy and safety of olodaterol once daily delivered via RespimatR in patients with GOLD 2–4 COPD: results from two replicate 48-week studies. Int J Chron Obstruct Pulm Dis 2014; 9: 629–45.
18. Fletcher MJ, Upton J, Taylor-Fishwick J et al. COPD uncovered: an international survey on the impact of chronic obstructive pulmonary disease [COPD] on a working age population. BMC Public Health 2011; 11: 612.
19. Gibb A, Yang LP. Olodaterol: first global approval. Drugs 2013; 73 (16): 1841–6.
20. Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease. NHLBI/WHO workshop report updated 2015.
21. Global Strategy for Asthma Management and Prevention (2015 update).
22. Gross NG. Anticholinergic therapy in chronic obstructive pulmonary disease. London: Franclin Scientific, 1993.
23. Guyatt GH Townsend M, Pugsley SO et al. Bronchodilators in chronic airflow limitation. Effects on airway function, exercise capacity, and quality of life. Am Rev Respir Dis 1987; 135 (5): 1069–74.
24. Hanania NA, Feldman G, Zachgo W et al. The efficacy and safety of the novel long-acting b2-agonist vilanterol in patients with COPD: a randomized placebo-controlled trial. Chest 2012; 142 (1): 119–27.
25. Jones TR, Charette L, Garcia ML, Kaczorowski GJ. Selective inhibition of relaxation of guinea-pig trachea by charybdotoxin, a potent Ca++-activated K+-channel inhibitor. J Pharmacol Exp Ther 1990; 255: 697–706.
26. Kanniess F, Boulet LP, Pierzchala W et al. Efficacy and safety of indacaterol, a new 24-h b2-agonist, in patients with asthma: a dose-ranging study. J Asthma 2008; 45: 887–92.
27. Kempsford R, Norris V, Siederer S. Vilanterol trifenatate, a novel inhaled long-acting beta2-adrenoceptor agonist, is well tolerated in healthy subjects and demonstrates prolonged bronchodilation in subjects with asthma and COPD. Pulm Pharmacol Ther 2013; 26 (2): 256–64.
28. Kew KM, Dias S, Cates CJ. Long-acting inhaled therapy (beta-agonists, anticholinergics and steroids) for COPD: a network meta-analysis. Cochrane Database Syst Rev 2014; Issue 3: Art. No.: CD010844. Doi: 10.1002/14651858. CD010844.pub2.
29. Kew KM, Evans DJ, Allison DE, Boyter AC. Long-acting muscarinic antagonists (LAMA) added to inhaled corticosteroids (ICS) versus addition of long-acting beta2-agonists (LABA) for adults with asthma. Cochrane Database Syst Rev 2015; 6: CD011438. Doi: 10.1002/14651858.CD011438.pub2.
30. Kornmann O, Dahl R, Centanni S et al. Once-daily indacaterol vs twice-daily salmeterol for COPD: a placebo controlled comparison. Eur Respir J 2011; 37: 273–9.
31. Kuehn BM. FDA offers advice to reduce risks of long-acting beta-agonists in asthma care. JAMA 2010; 303 (14): 1353–4.
32. LaForce C, Alexander M, Deckelmann R et al. Indacaterol provides sustained 24 h bronchodilation on once-daily dosing in asthma: a 7-day dose-ranging study. Allergy 2008; 63: 103–11.
33. LaForce C, Korenblat P, Osborne P et al. 24-hour bronchodilator efficacy of single doses of indacaterol in patients with persistent asthma: comparison with placebo and formoterol. Curr Med Res Opin 2009; 25: 2353–9.
34. Lee TA, Pickard AS, Au DH et al. Risk for death associated with medications for recently diagnosed chronic obstructive pulmonary disease. Ann Intern Med 2008; 149: 380–90.
35. Lombardi D, Cuenoud B, Kramer SD. Lipid membrane interactions of indacaterol and salmeterol: do they influence their pharmacological properties? Eur J Pharm Sci 2009; 38: 533– 47.
36. Lopez AD, Shibuya K, Rao C et al. Chronic obstructive pulmonary disease: current burden and future projections. Eur Respir J 2006; 27 (2): 397–412.
37. Lotvall J, Bateman ED, Bleecker ER et al. 24h duration of the novel LABA vilanterol trifenatate in asthma patients treated with inhaled corticosteroids. Eur Respir J 2012; 40 (3): 570–9.
38. Masoli M, Fabian D, Holt S, Beasley R. The global burden of asthma: executive summary of the GINA Dissemination Committee report. Allergy 2004; 59: 469–78.
39. Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med 2006; 3: e442.
40. Meurs H. A new perspective on muscarinic receptor antagonism in obstructive airway disease. Curr Opin Pharmacol 2013; 13: 316–23.
41. McIntyre E, Alpers JH, Ruffin RE. Bronchial smooth muscle tone in normal subjects. Chest 1982; 81 (3): 396.
42. McKay SE, Howie CA, Thomson AH et al. Value of theophylline treatment in patients handicapped by chronic obstructive lung disease. Thorax 1993; 48 (3): 227–32.
43. Murciano D, Auclair MH, Pariente R, Aubier M. A randomized, controlled trial of theophylline in patients with severe chronic obstructive pulmonary disease. N Engl J Med 1989; 320 (23): 1521–5.
44. Naline E, Trifilieff A, Fairhurst RA et al. Effect of indacaterol, a novel long acting b2-agonist, on isolated human bronchi. Eur Respir J 2007; 29: 575–81.
45. Pearlman DS, Greos L, LaForce C et al. Bronchodilator efficacy of indacaterol, a novel once-daily beta2-agonist, in patients with persistent asthma. Ann Allergy Asthma Immunol 2008; 101: 90–5.
46. Procopiou PA, Barrett VJ, Bevan NJ et al. Synthesis and structure-activity relationships of long-acting beta2 adrenergic receptor agonists incorporating metabolic inactivation: an antedrug approach. J Med Chem 2010; 53 (11): 4522–30.
47. Rosethorne EM, Turner RJ, Fairhurst RA, Charlton SJ. Efficacy is a contributing factor to the clinical onset of bronchodilation of inhaled b2-adrenoceptor agonists. Naunyn Schmiedebergs Arch Pharmacol 2010; 382: 255–63.
48. Salpenter SR, Buckley NS, Salpenter EE. Meta-analiysis: anticholinergics, but not b2-agonists, reduce severe exacerbations and respiratory mortality in COPD. J Gen Intern Med 2006; 21: 1011–9.
49. Sharpe TR, Mikeal RL. Patient compliance with prescription medication regimens. J Am Pharm Assoc 1975; 15 (4): 191–2.
50. Singh S, Loke YK, Furberg CD. Inhaled anticholinergics and risk of major adverse cardiovascular events in patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis. JAMA 2008; 300: 1439–50.
51. Singh S, Loke YK, Enright PL, Furberg CD. Mortality associated with tiotropium mist inhaler in patients with chronic obstructive pulmonary disease: systematic review and meta-analysis of randomised controlled trials. BMJ 2011; 342: d3215.
52. Singh S, Loke YK, Enright P, Furberg CD. Pro-arrhythmic and pro-ischaemic effects of inhaled anticholinergic medications. Thorax 2013; 68 (1): 114–6.
53. Sturton RG, Trifilieff A, Nicholson AG, Barnes PJ. Pharmacological characterization of indacaterol, a novel once daily inhaled _2 adrenoceptor agonist, on small airways in human and rat precision-cut lung slices. J Pharmacol Exp Ther 2008; 324: 270–5.
54. Sugihara N, Kanada S, Haida M et al. 24-h bronchodilator efficacy of single doses of indacaterol in Japanese patients with asthma: A comparison with placebo and salmeterol. Respir Med 2010; 104: 1629–37.
55. Tashkin DP, Celli B, Senn S et al. UPLIFT Study Investigators. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med 2004; 359: 1543–54.
56. Van den Boom G, Van Schayck CP, Van Mollen MP et al. Active detection of chronic obstructive pulmonary disease and asthma in the general population. Results and economic consequences of the DIMCA program. Am J Respir Crit Care Med 1998; 158: 1730–8.
57. Van Noord JA, Smeets JJ, Drenth BM et al. 24Hour bronchodilation following a single dose of the novel β2agonist olodaterol in COPD. Pulm Pharmacol Ther 2011; 24: 666–72.
58. Yang WH, Martinot JB, Pohunek P et al. Tolerability of indacaterol, a novel once-daily beta2-agonist, in patients with asthma: a randomized, placebo-controlled, 28-day safety study. Ann Allergy Asthma Immunol 2007; 99: 555–61.
59. Zhou Y, Wang X, Zeng X et al. Positive benefits of theophylline in a randomized, double-blind, parallel group, placebo controlled study of low-dose, slow-release theophylline in the treatment of COPD for 1 year. Respirology 2006; 11 (5): 603–10.
Авторы
М.А.Куценко
ГБОУ ВПО Российский национальный исследовательский медицинский университет им. Н.И.Пирогова Минздрава. 117997, Россия, Москва, ул. Островитянова, д. 1;
ФГБУ НИИ пульмонологии ФМБА России. 105077, Россия, Москва, 11-я Парковая ул., д. 32
mkmed@yandex.ru
ГБОУ ВПО Российский национальный исследовательский медицинский университет им. Н.И.Пирогова Минздрава. 117997, Россия, Москва, ул. Островитянова, д. 1;
ФГБУ НИИ пульмонологии ФМБА России. 105077, Россия, Москва, 11-я Парковая ул., д. 32
mkmed@yandex.ru
________________________________________________
M.A.Koutsenko
N.I.Pirogov Russian National Research Medical University of the Ministry of Health of the Russian Federation. 117997, Russian Federation, Moscow, ul. Ostrovitianova, d. 1;
Research Institute for Pulmonology. 105077, Russian Federation, Moscow, 11-ia Parkovaia ul., d. 32
mkmed@yandex.ru
N.I.Pirogov Russian National Research Medical University of the Ministry of Health of the Russian Federation. 117997, Russian Federation, Moscow, ul. Ostrovitianova, d. 1;
Research Institute for Pulmonology. 105077, Russian Federation, Moscow, 11-ia Parkovaia ul., d. 32
mkmed@yandex.ru
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