Risk of pneumonia with budesonide-containing treatments in COPD: An individual patient-level pooled analysis of interventional studies

International Journal of COPD

Volumn 12, Issue , 2017, Pages 1071-1084

  Hollis, Sally ^a   Jorup, Carin ^b   Lythgoe, Dan ^c   Martensson, Gunnar ^b   Regnell, Pontus ^b   Eckerwall, Göran ^b  

^a ASTRAZENECA   (United Kingdom)

^b ASTRAZENECA R AND D   (Sweden)

^c PHASTAR   (United Kingdom)

Author keywords

Budesonide; COPD; Inhaled corticosteroid; Pneumonia

Indexed keywords

BUDESONIDE; BUDESONIDE PLUS FORMOTEROL; FORMOTEROL; PLACEBO; BRONCHODILATING AGENT; GLUCOCORTICOID;

ADULT; AGED; ARTICLE; CHRONIC OBSTRUCTIVE LUNG DISEASE; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FEMALE; HUMAN; INCIDENCE; INTERVENTION STUDY; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; OUTCOME ASSESSMENT; PARALLEL DESIGN; PNEUMONIA; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; TREATMENT DURATION; TREATMENT RESPONSE; CHEMICALLY INDUCED; DRUG EFFECTS; INHALATIONAL DRUG ADMINISTRATION; LUNG; PATHOPHYSIOLOGY; PROPORTIONAL HAZARDS MODEL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK FACTOR; TIME FACTOR; TREATMENT OUTCOME;

ADMINISTRATION, INHALATION; AGED; BRONCHODILATOR AGENTS; BUDESONIDE; FEMALE; GLUCOCORTICOIDS; HUMANS; LUNG; MALE; MIDDLE AGED; PNEUMONIA; PROPORTIONAL HAZARDS MODELS; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RISK ASSESSMENT; RISK FACTORS; TIME FACTORS; TREATMENT OUTCOME;

EID: 85017320054     PISSN: 11769106     EISSN: 11782005     Source Type: Journal    
DOI: 10.2147/COPD.S128358     Document Type: Article

References (44)

1. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for Diagnosis, Management, and Prevention of COPD; 2016. Available from: http://goldcopd.org/global-strategy-diagnosis-management-prevention-copd-2016/. Accessed April 2, 2016.
2. 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;361(9356):449-456.
3. Calverley PM, Anderson JA, Celli B, et al. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N Engl J Med. 2007;356(8):775-789.
4. Singh S, Loke YK. Risk of pneumonia associated with long-term use of inhaled corticosteroids in chronic obstructive pulmonary disease: a critical review and update. Curr Opin Pulm Med. 2010;16(2): 118-122.
5. Yang IA, Clarke MS, Sim EH, Fong KM. Inhaled corticosteroids for stable chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2012(7):CD002991.
6. Suissa S, Patenaude V, Lapi F, Ernst P. Inhaled corticosteroids in COPD and the risk of serious pneumonia. Thorax. 2013;68(11): 1029-1036.
7. Suissa S, Coulombe J, Ernst P. Discontinuation of inhaled corticosteroids in COPD and the risk reduction of pneumonia. Chest. 2015;148(5): 1177-1183.
8. Kew KM, Seniukovich A. Inhaled steroids and risk of pneumonia for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2014;3:CD010115.
9. European Medicines Agency. Inhaled corticosteroids containing medicinal products indicated in the treatment of chronic obstructive pulmonary disease. 2015; Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Inhaled_corticosteroids_for_chronic_obstructive_pulmonary_disease/human_referral_prac_000050.jsp&mid=WC0b01ac05805c516f. Accessed July 2, 2016.
10. ICH Harmonised Tripartite Guideline. Clinical Safety Data Management: Definitions and Standards for Expedited Reporting E2A (1994; updated 2005). Available from: http://www.gmp-compliance.org/guidemgr/files/E2A_GUIDELINE.PDF. Accessed April 2, 2016.
11. Smith CT, Williamson PR, Marson AG. Investigating heterogeneity in an individual patient data meta-analysis of time to event outcomes. Stat Med. 2005;24(9):1307-1319.
12. Higgins JP, Thompson SG. Quantifying heterogeneity in a meta-analysis. Stat Med. 2002;21(11):1539-1558.
13. Sin DD, Tashkin D, Zhang X, et al. Budesonide and the risk of pneumonia: a meta-analysis of individual patient data. Lancet. 2009; 374(9691):712-719.
14. Bourbeau J, Rouleau MY, Boucher S. Randomised controlled trial of inhaled corticosteroids in patients with chronic obstructive pulmonary disease. Thorax. 1998;53(6):477-482.
15. Calverley PM, Boonsawat W, Cseke Z, Zhong N, Peterson S, Olsson H. Maintenance therapy with budesonide and formoterol in chronic obstructive pulmonary disease. Eur Respir J. 2003;22(6):912-919.
16. Fukuchi Y, Samoro R, Fassakhov R, et al. Budesonide/formoterol via Turbuhaler(R) versus formoterol via Turbuhaler(R) in patients with moderate to severe chronic obstructive pulmonary disease: phase III multinational study results. Respirology. 2013;18(5):866-873.
17. Pauwels RA, Löfdahl CG, Laitinen LA, et al. Long-term treatment with inhaled budesonide in persons with mild chronic obstructive pulmonary disease who continue smoking. European Respiratory Society Study on Chronic Obstructive Pulmonary Disease. N Engl J Med. 1999; 340(25):1948-1953.
18. Rennard SI, Tashkin DP, McElhattan J, et al. Efficacy and tolerability of budesonide/formoterol in one hydrofluoroalkane pressurized metered-dose inhaler in patients with chronic obstructive pulmonary disease: results from a 1-year randomized controlled clinical trial. Drugs. 2009; 69(5):549-565.
19. Sharafkhaneh A, Southard JG, Goldman M, Uryniak T, Martin UJ. Effect of budesonide/formoterol pMDI on COPD exacerbations: a double-blind, randomized study. Respir Med. 2012;106(2): 257-268.
20. Szafranski W, Cukier A, Ramirez A, et al. Efficacy and safety of budesonide/formoterol in the management of chronic obstructive pulmonary disease. Eur Respir J. 2003;21(1):74-81.
21. Tashkin DP, Rennard SI, Martin P, et al. Efficacy and safety of budesonide and formoterol in one pressurized metered-dose inhaler in patients with moderate to very severe chronic obstructive pulmonary disease: results of a 6-month randomized clinical trial. Drugs. 2008; 68(14):1975-2000.
22. Vestbo J, Sørensen T, Lange P, Brix A, Torre P, Viskum K. Long-term effect of inhaled budesonide in mild and moderate chronic obstructive pulmonary disease: a randomised controlled trial. Lancet. 1999; 353(9167):1819-1823.
23. Welte T, Miravitlles M, Hernandez P, et al. Efficacy and tolerability of budesonide/formoterol added to tiotropium in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2009;180(8): 741-750.
24. Shaker SB, Dirksen A, Ulrik CS. The effect of inhaled corticosteroids on the development of emphysema in smokers assessed by annual computed tomography. COPD. 2009;6(2):104-111.
25. Sin D, Tashkin D, Radner F, et al. An update on the risk of pneumonia related to budesonide use in COPD: Pooled analysis. Am J Respir Crit Care Med. 2012;185:A2945.
26. Laptseva IM, Laptseva EA, Borshchevsky VV, Gurevich G, Kalechits O. Inhaled budesonide in the management of chronic obstructive pulmonary disease. Eur Respir J. 2002;20(Suppl 38):244s.
27. Mirici A, Bektas Y, Ozbakis G, Erman Z. Effect of inhaled corticosteroids on respiratory function tests and airway inflammation in stable chronic obstructive pulmonary disease. Clin Drug Investig. 2001;21(12): 835-842.
28. Ozol D, Aysan T, Solak ZA, Mogulkoc N, Veral A, Sebik F. The effect of inhaled corticosteroids on bronchoalveolar lavage cells and IL-8 levels in stable COPD patients. Respir Med. 2005;99(12):1494-1500.
29. Renkema TE, Schouten JP, Koëter GH, Postma DS. Effects of long-term treatment with corticosteroids in COPD. Chest. 1996;109(5): 1156-1162.
30. Senderovitz T, Vestbo J, Frandsen J, et al. Steroid reversibility test followed by inhaled budesonide or placebo in outpatients with stable chronic obstructive pulmonary disease. The Danish Society of Respiratory Medicine. Respir Med. 1999;93(10):715-718.
31. Yildiz F, Basyigit I, Yildirim E, Boyaci H, Ilgazli A. Does addition of inhaled steroid to combined bronchodilator therapy affect health status in patients with COPD? Respirology. 2004;9(3):352-355.
32. Calverley PM, Kuna P, Monsó E, et al. Beclomethasone/formoterol in the management of COPD: a randomised controlled trial. Respir Med. 2010;104(12):1858-1868.
33. European Federation of Pharmaceutical Industries and Associations (efpia) and Pharmaceutical Research and Manufacturers of America (PhRMA) 2013. Principles for Responsible Clinical Trial Data Sharing. Available from: http://www.phrma.org/sites/default/files/pdf/PhRMAPrinciplesForResponsibleClinicalTrialDataSharing.pdf. Accessed April 2, 2016.
34. Pauwels RA, Sears MR, Campbell M, et al. Formoterol as relief medication in asthma: a worldwide safety and effectiveness trial. Eur Respir J. 2003;22(5):787-794.
35. Sheffer AL, Silverman M, Woolcock AJ, Díaz PV, Lindberg B, Lindmark B. Long-term safety of once-daily budesonide in patients with early-onset mild persistent asthma: results of the Inhaled Steroid Treatment as Regular Therapy in Early Asthma (START) study. Ann Allergy Asthma Immunol. 2005;94(1):48-54.
36. Halpin DM, Gray J, Edwards SJ, Morais J, Singh D. Budesonide/formoterol vs. salmeterol/fluticasone in COPD: a systematic review and adjusted indirect comparison of pneumonia in randomised controlled trials. Int J Clin Pract. 2011;65(7):764-774.
37. Roberts M, Mapel D, Petersen H, Blanchette C, Ramachandran S. Comparative effectiveness of budesonide/formoterol and fluticasone/salmeterol for COPD management. J Med Econ. 2011;14(6):769-776.
38. Miller-Larsson A, Jansson P, Runström A, Brattsand R. Prolonged airway activity and improved selectivity of budesonide possibly due to esterification. Am J Respir Crit Care Med. 2000;162(4 Pt 1): 1455-1461.
39. Crim C, Calverley PM, Anderson JA, et al. Pneumonia risk in COPD patients receiving inhaled corticosteroids alone or in combination: TORCH study results. Eur Respir J. 2009;34(3):641-647.
40. Janson C, Larsson K, Lisspers KH, et al. Pneumonia and pneumonia related mortality in patients with COPD treated with fixed combinations of inhaled corticosteroid and long acting beta2 agonist: observational matched cohort study (PATHOS). BMJ. 2013;346:f3306.
41. Jen R, Rennard SI, Sin DD. Effects of inhaled corticosteroids on airway inflammation in chronic obstructive pulmonary disease: a systematic review and meta-analysis. Int J Chron Obstruct Pulmon Dis. 2012;7:587-595.
42. Ek A, Larsson K, Siljerud S, Palmberg L, et al. Fluticasone and budesonide inhibit cytokine release in human lung epithelial cells and alveolar macrophages. Allergy. 1999;54(7):691-699.
43. Latorre M, Novelli F, Vagaggini B, et al. Differences in the efficacy and safety among inhaled corticosteroids (ICS)/long-acting beta2-agonists (LABA) combinations in the treatment of chronic obstructive pulmonary disease (COPD): Role of ICS. Pulmo Pharmacol Ther. 2015; 30:44-50.
44. EMA. PRAC Reviews Known Risk of Pneumonia with Inhaled Corticosteroids for Chronic Obstructive Pulmonary Disease; 2016. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Inhaled_corticosteroids_Article_31/Recommendation_provided_by_Pharmacovigilance:Risk_Assessment_Committee/WC500203472.pdf. Accessed April, 2016.