Rewolucyjne zmiany w raporcie GINA 2019 – jeden inhalator w terapii podtrzymującej i ratunkowej dla większości chorych na astmę
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Opublikowane:
cze 26, 2019
Słowa kluczowe:
astma, GINA 2019, SMART, glikokortykosteroidy wziewne, budezonid, formoterol, inhalatory suchego proszku
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Abstrakt
Raport GINA 2019 wprowadza rewolucyjne zmiany w farmakoterapii astmy u dzieci w wieku > 5 lat, młodzieży i dorosłych. Ze względów bezpieczeństwa eksperci raportu GINA 2019 nie zalecają już stosowania krótko działających b2-mimetyków (SABA) w monoterapii, lecz zawsze w połączeniu z glikokortykosteroidem wziewnym (GKSw). U wszystkich dorosłych oraz dzieci w wieku ≥ 12 lat preferowanym leczeniem kontrolującym są GKSw w dawce zależnej od objawów astmy lub glikokortykosteroidy wziewne z formoterolem w schemacie SMART/MART (terapia podtrzymująca i ratunkowa z tego samego inhalatora). Alternatywa to glikokortykosteroidy wziewne z długo działającym b2-mimetykiem w dawkowaniu „sztywnym” oraz SABA „na żądanie”. Optymalnym sposobem leczenia dla zdecydowanej większości chorych na astmę w wieku ≥ 12 lat jest obecnie terapia SMART/MART, najskuteczniej zapobiegająca zaostrzeniom choroby. Może być ona realizowana za pomocą budezonidu z formoterolem z inhalatorów suchego proszku (Easyhaler®, Turbuhaler® i Spiromax®) lub beklometazonu z formoterolem z inhalatora ciśnieniowego dozującego.
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Emeryk , A., & Emeryk-Maksymiuk , J. (2019). Rewolucyjne zmiany w raporcie GINA 2019 – jeden inhalator w terapii podtrzymującej i ratunkowej dla większości chorych na astmę . Alergoprofil, 15(2), 3-11. https://doi.org/10.24292/01.AP.152200619
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Utwór dostępny jest na licencji Creative Commons Uznanie autorstwa – Użycie niekomercyjne 4.0 Międzynarodowe.
Copyright: © Medical Education sp. z o.o. This is an Open Access article distributed under the terms of the Attribution-NonCommercial 4.0 International (CC BY-NC 4.0). License (https://creativecommons.org/licenses/by-nc/4.0/), allowing third parties to copy and redistribute the material in any medium or format and to remix, transform, and build upon the material, provided the original work is properly cited and states its license.
Address reprint requests to: Medical Education, Marcin Kuźma (marcin.kuzma@mededu.pl)
Bibliografia
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6. Bateman ED, Harrison TW, Quirce S et al. Overall asthma control achieved with budesonide/formoterol maintenance and reliever therapy for patients on different treatment steps. Respir Res 2011, 12: 38.
7. Bousquet J, Boulet LP, Peters MJ et al. Budesonide/formoterol for maintenance and relief in uncontrolled asthma vs. high-dose salmeterol/fluticasone. Respir Med 2007, 101(12): 2437-1446.
8. Vogelmeier C, D’Urzo A, Pauwels R et al. Budesonide/formoterol maintenance and reliever therapy: an effective asthma treatment option? Eur Respir J 2005, 26(5): 819-828.
9. Buhl R, Vogelmeier C. Budesonide/formoterol maintenance and reliever therapy: a new treatment approach for adult patients with asthma. Curr Med Res Opin 2007, 23(8): 1867-1878.
10. O’Byrne PM, Bisgaard H, Godard PP et al. Budesonide/formoterol combination therapy as both maintenance and reliever medication in asthma. Am J Respir Crit Care Med 2005, 171: 129-136.
11. O’Byrne PM. Acute asthma intervention: insights from the STAY study. J Allergy Clin Immunol 2007, 119(6): 1332-1336.
12. Kuna P, Peters MJ, Manjra AI et al. Effect of budesonide/formoterol maintenance and reliever therapy on asthma exacerbations. Int J Clin Pract 2007, 61: 725-736.
13. Bisgaard H, Le Roux P, Bjåmer D et al. Budesonide/formoterol maintenance plus reliever therapy: a new strategy in pediatric asthma. Chest 2006, 130(6): 1733-1743.
14. Laube BL, Janssens HM, de Jongh FH et al. What the pulmonary specialist should know about the new inhalation therapies. Eur Respir J 2011, 37: 1308-1331.
15. Braido F, Chrystyn H, Baiardini I et al. ″Trying, but failing″ – the role of inhaler technique and mode of delivery in respiratory medication adherence. J Allergy Clin Immunol Pract 2016, 4: 823-832.
16. Mäkelä MJ, Backer V, Hedegaard M et al. Adherence to inhaled therapies, health outcomes and costs in patients with asthma and COPD. Respir Med 2013, 107: 1481-1490.
17. Raport Global Strategy for Asthma Management and Prevention – Revised 2014 [online: http://www.ginasthma.org] . Dostęp: 12.05.2019 r.
18. Papi A, Corradi M, Pigeon-Francisco C et al. Beclometasone-formoterol as maintenance and reliever treatment in patients with asthma: a double-blind, randomised controlled trial. Lancet Respir Med 2013, 1: 23-31.
19. Kupryś-Lipińska I, Kuna P. Zmiany w najnowszych Wytycznych Leczenia i Prewencji Astmy – GINA 2014. Na co powinniśmy zwrócić uwagę? Pneumonol Alergol Pol 2014, 82: 393-401.
20. Lin J, Zhou X, Wang C et al. Symbicort® Maintenance and Reliever Therapy (SMART) and the evolution of asthma management within the GINA guidelines. Expert Rev Respir Med 2018, 12(3): 191-202.
21. Czarnecka K, Chapman KR. The clinical impact of single inhaler therapy in asthma. Clin Exp Allergy 2012, 42(7): 1006-1013.
22. Sobieraj DM, Weeda ER, Nguyen E et al. Association of inhaled corticosteroids and long-acting β-agonists as controller and quick relief therapy with exacerbations and symptom control in persistent asthma: a systematic review and meta-analysis. JAMA 2018, 319(14): 1485-1496.
23. Bateman ED, Reddel HK, O’Byrne PM et al. As-needed budesonide– formoterol versus maintenance budesonide in mild asthma. N Engl J Med 2018, 378: 1877-1887.
24. O’Byrne PM, FitzGerald JM, Bateman ED et al. Inhaled Combined Budesonide-Formoterol as Needed in Mild Asthma. N Engl J Med 2018, 378(20): 1865-1876.
25. Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention. [online: http://ginasthma.org/2018-gina-report-global-strategy-for-asthma-management-and-prevention/]]. Dostęp: 20.05.2019 r.
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27. National Heart, Lung, and Blood Institute Advisory Council Asthma Expert Working Group Needs Assessment Report for Potential Update of the Expert Panel Report-3 (2007). Guidelines for the Diagnosis and Management of Asthma; Bethesda, MD: National Heart, Lung, and Blood Institute. Updated 2011. [online: https://www.nhlbi.nih.gov/health-topics/guidelines-fordiagnosis-management-of-asthma] ]. Dostęp: 20.05.2019 r.
28. Pavord ID, Jeffery PK, Qiu Y et al. Airway inflammation in patients with asthma with high-fixed or low-fixed plus as-needed budesonide/formoterol. J Allergy Clin Immunol 2009, 123: 1083-1089.
29. O’Byrne PM, Jenkins C, Bateman ED. The paradoxes of asthma management: time for a new approach? Eur Respir J 2017, 50: 1701103.
30. Szefler SJ, Chipps B. Challenges in the treatment of asthma in children and adolescents. Ann Allergy Asthma Immunol 2018, 120: 382-388.
31. Belhassen M, Nibber A, Van Ganse E et al. Inappropriate asthma therapy-a tale of two countries: a parallel population-based cohort study. NPJ Prim Care Respir Med 2016, 26: 16076.
32. Rabe KF, Vermeire PA, Soriano JB, Maier WC. Clinical management of asthma in 1999: the Asthma Insights and Reality in Europe (AIRE) study. Eur Respir J 2000, 16(5): 802-807.
33. Sadatsafavi M, Tavakoli H, Lynd L et al. Has asthma medication use caught up with the evidence? A 12-year population-based study of trends. Chest 2017, 151: 612-618.
34. Hancox RJ, Cowan JO, Flannery EM et al. Bronchodilator tolerance and rebound bronchoconstriction during regular inhaled beta-agonist treatment. Respir Med 2000, 94(8): 767-771.
35. Sears MR. Adverse effects of beta-agonists. J Allergy Clin Immunol 2002, 110(6): S322-328.
36. Drazen JM, Israel E, Boushey HA et al. Comparison of regularly scheduled with as-needed use of albuterol in mild asthma. Asthma Clinical Research Network. N Engl J Med 1996, 335: 841-847.
37. Stanford RH, Shah MB, D’Souza AO et al. Short-acting β-agonist use and its ability to predict future asthma-related outcomes. Ann Allergy Asthma Immunol 2012, 109: 403-407.
38. Sears MR, Lötvall J. Past, present and future – β2-adrenoceptor agonists in asthma management. Respir Med 2005, 99: 152-170.
39. Suissa S, Ernst P, Boivin JF et al. A cohort analysis of excess mortality in asthma and the use of inhaled beta-agonists. Am J Respir Crit Care Med 1994, 149(3 Pt 1): 604-610.
40. Aldridge RE, Hancox RJ, Taylor DR et al. Effects of terbutalineand budesonide on sputum cells and bronchial hyperresponsiveness in asthma. Am J Respir Crit Care Med 2000, 161(5): 1459-1464.
41. Aldridge RE, Hancox RJ, Cowant JO et al. Eosinophils and eosinophilic cationic protein in induced sputum and blood: effects of budesonide and terbutaline treatment. Ann Allergy Asthma Immunol 2002, 89: 492-497.
42. Papi A, Canonica GW, Maestrelli P et al. Rescue use of beclomethasone and albuterol in a single inhaler for mild asthma.N Engl J Med 2007, 356: 2040-2052.
43. [online http://leki.urpl.gov.pl/files/25n_BufomixEasyhaler_160.pdf]. Dostęp: 15.05.2019 r.
44. [online: http://leki.urpl.gov.pl/files/37_DuoResp_Spiromax_CEN.pdf]. Dostęp: 15.05.2019 r.
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48. Bodzenta-Lukaszyk A, Buhl R, Balint B et al. Fluticasone/formoterol combination therapy versus budesonide/formoterol for the treatment of asthma: a randomized, controlled, non-inferiority trial of efficacy and safety. J Asthma 2012, 49(10): 1060-1070.
49. Napp Pharmaceuticals Limited. flutiform® summary of product characteristics. (Last updated: October 2018) [online: http://www.medicines.org.uk/emc/medicine/26954]. Dostęp: May 2019.
50. Emeryk A, Pirożyński M, Emeryk-Maksymiuk J. Dry powder inhalers – between the doctor and the patient. Adv Respir Med 2018, 86: 44-52.
51. Emeryk A, Janeczek K, Emeryk-Maksymiuk J. Inhalatory suchego proszku – stare, nowe, generyczne. Terapia 2019, 27: 68-77.
52. Haidl P, Heindl S, Siemon K et al. Inhalation device requirements for patients’ inhalation maneuvers. Respir Med 2016, 118: 65-75.
53. Rönmark P, Jagorstrand B, Safioti G et al. Comparison of correct technique and preference for Spiromax®, Easyhaler® and Turbuhaler®: a single-site, single-visit, crossover study in inhaler-naïve adult volunteers. Eur Clin Respir J 2018, 5: 1529536.
54. Janson C, Lööf T, Telg G et al. Difference in resistance to humidity between commonly used dry powder inhalers: an in vitro study. NPJ Prim Care Respir Med 2016, 26: 16053.
55. Sandler N, Holländer J, Långström D et al. Evaluation of inhaler handling-errors, inhaler perception and preference with Spiromax, Easyhaler and Turbuhaler devices among healthy Finnish volunteers: a single site, single visit crossover study (Finhaler). BMJ Open Respir Res 2016, 3: e000119.
56. Sandler N, Holländer J, Långström D et al. Evaluation of inhaler perception and preference of Spiromax®, Easyhaler®, And Turbuhaler® devices (Finhaler). Value Health 2015, 18: A363.
57. Lewis A, Torvinen S, Dekhuijzen PNR et al. Budesonide + formoterol delivered via Spiromax® for the management of asthma and COPD: The potential impact on unscheduled healthcare costs of improving inhalation technique compared with Turbuhaler®. Respir Med 2017, 129: 179-188.
2. [online: https://ginasthma.org/]. Dostęp: 15.05.2019 r.
3. Chung LP, Paton JY. Two sides of the same coin? – treatment of chronic asthma in children and adults. Front Pediatr 2019, 7: 62.
4. [online: https://ginasthma.org/wp-content/uploads/2019/04/ GINA-2019-main-Pocket-Guide-wms.pdf]. Dostęp: 15.05.2019 r.
5. Zetterström O, Buhl R, Mellem H et al. Improved asthma control with budesonide/formoterol in a single inhaler, compared with budesonide alone. Eur Respir J 2001, 18: 262-268.
6. Bateman ED, Harrison TW, Quirce S et al. Overall asthma control achieved with budesonide/formoterol maintenance and reliever therapy for patients on different treatment steps. Respir Res 2011, 12: 38.
7. Bousquet J, Boulet LP, Peters MJ et al. Budesonide/formoterol for maintenance and relief in uncontrolled asthma vs. high-dose salmeterol/fluticasone. Respir Med 2007, 101(12): 2437-1446.
8. Vogelmeier C, D’Urzo A, Pauwels R et al. Budesonide/formoterol maintenance and reliever therapy: an effective asthma treatment option? Eur Respir J 2005, 26(5): 819-828.
9. Buhl R, Vogelmeier C. Budesonide/formoterol maintenance and reliever therapy: a new treatment approach for adult patients with asthma. Curr Med Res Opin 2007, 23(8): 1867-1878.
10. O’Byrne PM, Bisgaard H, Godard PP et al. Budesonide/formoterol combination therapy as both maintenance and reliever medication in asthma. Am J Respir Crit Care Med 2005, 171: 129-136.
11. O’Byrne PM. Acute asthma intervention: insights from the STAY study. J Allergy Clin Immunol 2007, 119(6): 1332-1336.
12. Kuna P, Peters MJ, Manjra AI et al. Effect of budesonide/formoterol maintenance and reliever therapy on asthma exacerbations. Int J Clin Pract 2007, 61: 725-736.
13. Bisgaard H, Le Roux P, Bjåmer D et al. Budesonide/formoterol maintenance plus reliever therapy: a new strategy in pediatric asthma. Chest 2006, 130(6): 1733-1743.
14. Laube BL, Janssens HM, de Jongh FH et al. What the pulmonary specialist should know about the new inhalation therapies. Eur Respir J 2011, 37: 1308-1331.
15. Braido F, Chrystyn H, Baiardini I et al. ″Trying, but failing″ – the role of inhaler technique and mode of delivery in respiratory medication adherence. J Allergy Clin Immunol Pract 2016, 4: 823-832.
16. Mäkelä MJ, Backer V, Hedegaard M et al. Adherence to inhaled therapies, health outcomes and costs in patients with asthma and COPD. Respir Med 2013, 107: 1481-1490.
17. Raport Global Strategy for Asthma Management and Prevention – Revised 2014 [online: http://www.ginasthma.org] . Dostęp: 12.05.2019 r.
18. Papi A, Corradi M, Pigeon-Francisco C et al. Beclometasone-formoterol as maintenance and reliever treatment in patients with asthma: a double-blind, randomised controlled trial. Lancet Respir Med 2013, 1: 23-31.
19. Kupryś-Lipińska I, Kuna P. Zmiany w najnowszych Wytycznych Leczenia i Prewencji Astmy – GINA 2014. Na co powinniśmy zwrócić uwagę? Pneumonol Alergol Pol 2014, 82: 393-401.
20. Lin J, Zhou X, Wang C et al. Symbicort® Maintenance and Reliever Therapy (SMART) and the evolution of asthma management within the GINA guidelines. Expert Rev Respir Med 2018, 12(3): 191-202.
21. Czarnecka K, Chapman KR. The clinical impact of single inhaler therapy in asthma. Clin Exp Allergy 2012, 42(7): 1006-1013.
22. Sobieraj DM, Weeda ER, Nguyen E et al. Association of inhaled corticosteroids and long-acting β-agonists as controller and quick relief therapy with exacerbations and symptom control in persistent asthma: a systematic review and meta-analysis. JAMA 2018, 319(14): 1485-1496.
23. Bateman ED, Reddel HK, O’Byrne PM et al. As-needed budesonide– formoterol versus maintenance budesonide in mild asthma. N Engl J Med 2018, 378: 1877-1887.
24. O’Byrne PM, FitzGerald JM, Bateman ED et al. Inhaled Combined Budesonide-Formoterol as Needed in Mild Asthma. N Engl J Med 2018, 378(20): 1865-1876.
25. Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention. [online: http://ginasthma.org/2018-gina-report-global-strategy-for-asthma-management-and-prevention/]]. Dostęp: 20.05.2019 r.
26. British guideline on the management of asthma. A national clinical guideline. British Thoracic Society Scottish Intercollegiate Guidelines Network. Revised 2016. [online: https://www.brit-thoracic.org.uk/quality-improvement/guidelines/asthma]]. Dostęp: 20.05.2019 r.
27. National Heart, Lung, and Blood Institute Advisory Council Asthma Expert Working Group Needs Assessment Report for Potential Update of the Expert Panel Report-3 (2007). Guidelines for the Diagnosis and Management of Asthma; Bethesda, MD: National Heart, Lung, and Blood Institute. Updated 2011. [online: https://www.nhlbi.nih.gov/health-topics/guidelines-fordiagnosis-management-of-asthma] ]. Dostęp: 20.05.2019 r.
28. Pavord ID, Jeffery PK, Qiu Y et al. Airway inflammation in patients with asthma with high-fixed or low-fixed plus as-needed budesonide/formoterol. J Allergy Clin Immunol 2009, 123: 1083-1089.
29. O’Byrne PM, Jenkins C, Bateman ED. The paradoxes of asthma management: time for a new approach? Eur Respir J 2017, 50: 1701103.
30. Szefler SJ, Chipps B. Challenges in the treatment of asthma in children and adolescents. Ann Allergy Asthma Immunol 2018, 120: 382-388.
31. Belhassen M, Nibber A, Van Ganse E et al. Inappropriate asthma therapy-a tale of two countries: a parallel population-based cohort study. NPJ Prim Care Respir Med 2016, 26: 16076.
32. Rabe KF, Vermeire PA, Soriano JB, Maier WC. Clinical management of asthma in 1999: the Asthma Insights and Reality in Europe (AIRE) study. Eur Respir J 2000, 16(5): 802-807.
33. Sadatsafavi M, Tavakoli H, Lynd L et al. Has asthma medication use caught up with the evidence? A 12-year population-based study of trends. Chest 2017, 151: 612-618.
34. Hancox RJ, Cowan JO, Flannery EM et al. Bronchodilator tolerance and rebound bronchoconstriction during regular inhaled beta-agonist treatment. Respir Med 2000, 94(8): 767-771.
35. Sears MR. Adverse effects of beta-agonists. J Allergy Clin Immunol 2002, 110(6): S322-328.
36. Drazen JM, Israel E, Boushey HA et al. Comparison of regularly scheduled with as-needed use of albuterol in mild asthma. Asthma Clinical Research Network. N Engl J Med 1996, 335: 841-847.
37. Stanford RH, Shah MB, D’Souza AO et al. Short-acting β-agonist use and its ability to predict future asthma-related outcomes. Ann Allergy Asthma Immunol 2012, 109: 403-407.
38. Sears MR, Lötvall J. Past, present and future – β2-adrenoceptor agonists in asthma management. Respir Med 2005, 99: 152-170.
39. Suissa S, Ernst P, Boivin JF et al. A cohort analysis of excess mortality in asthma and the use of inhaled beta-agonists. Am J Respir Crit Care Med 1994, 149(3 Pt 1): 604-610.
40. Aldridge RE, Hancox RJ, Taylor DR et al. Effects of terbutalineand budesonide on sputum cells and bronchial hyperresponsiveness in asthma. Am J Respir Crit Care Med 2000, 161(5): 1459-1464.
41. Aldridge RE, Hancox RJ, Cowant JO et al. Eosinophils and eosinophilic cationic protein in induced sputum and blood: effects of budesonide and terbutaline treatment. Ann Allergy Asthma Immunol 2002, 89: 492-497.
42. Papi A, Canonica GW, Maestrelli P et al. Rescue use of beclomethasone and albuterol in a single inhaler for mild asthma.N Engl J Med 2007, 356: 2040-2052.
43. [online http://leki.urpl.gov.pl/files/25n_BufomixEasyhaler_160.pdf]. Dostęp: 15.05.2019 r.
44. [online: http://leki.urpl.gov.pl/files/37_DuoResp_Spiromax_CEN.pdf]. Dostęp: 15.05.2019 r.
45. [online: http://leki.urpl.gov.pl/files/25_Fostex_aeroz_inhal.pdf]. Dostęp: 15.05.2019 r.
46. [online: https://pub.rejestrymedyczne.csioz.gov.pl/Pobieranie. ashx?type=29165-c]. Dostęp: 15.05.2019 r.
47. [online: https://pub.rejestrymedyczne.csioz.gov.pl/Pobieranie. ashx?type=29165-c]. Dostęp: 15.05.2019 r.
48. Bodzenta-Lukaszyk A, Buhl R, Balint B et al. Fluticasone/formoterol combination therapy versus budesonide/formoterol for the treatment of asthma: a randomized, controlled, non-inferiority trial of efficacy and safety. J Asthma 2012, 49(10): 1060-1070.
49. Napp Pharmaceuticals Limited. flutiform® summary of product characteristics. (Last updated: October 2018) [online: http://www.medicines.org.uk/emc/medicine/26954]. Dostęp: May 2019.
50. Emeryk A, Pirożyński M, Emeryk-Maksymiuk J. Dry powder inhalers – between the doctor and the patient. Adv Respir Med 2018, 86: 44-52.
51. Emeryk A, Janeczek K, Emeryk-Maksymiuk J. Inhalatory suchego proszku – stare, nowe, generyczne. Terapia 2019, 27: 68-77.
52. Haidl P, Heindl S, Siemon K et al. Inhalation device requirements for patients’ inhalation maneuvers. Respir Med 2016, 118: 65-75.
53. Rönmark P, Jagorstrand B, Safioti G et al. Comparison of correct technique and preference for Spiromax®, Easyhaler® and Turbuhaler®: a single-site, single-visit, crossover study in inhaler-naïve adult volunteers. Eur Clin Respir J 2018, 5: 1529536.
54. Janson C, Lööf T, Telg G et al. Difference in resistance to humidity between commonly used dry powder inhalers: an in vitro study. NPJ Prim Care Respir Med 2016, 26: 16053.
55. Sandler N, Holländer J, Långström D et al. Evaluation of inhaler handling-errors, inhaler perception and preference with Spiromax, Easyhaler and Turbuhaler devices among healthy Finnish volunteers: a single site, single visit crossover study (Finhaler). BMJ Open Respir Res 2016, 3: e000119.
56. Sandler N, Holländer J, Långström D et al. Evaluation of inhaler perception and preference of Spiromax®, Easyhaler®, And Turbuhaler® devices (Finhaler). Value Health 2015, 18: A363.
57. Lewis A, Torvinen S, Dekhuijzen PNR et al. Budesonide + formoterol delivered via Spiromax® for the management of asthma and COPD: The potential impact on unscheduled healthcare costs of improving inhalation technique compared with Turbuhaler®. Respir Med 2017, 129: 179-188.