Withdrawal of inhaled corticosteroids can be safe in COPD patients at low risk of exacerbation: a real-life study on the appropriateness of treatment in moderate COPD patients (OPTIMO)

Respiratory Research

Antonio Corrado¹  Massimo Guerriero³  Andrea Rossi² 

[1] Respiratory Intensive Care Unit and Thoracic Physiopathology, University and General Hospital Careggi, Florence, Italy;Pulmonary Unit, General Hospital and University of Verona, Verona, Italy;Department of Computer Science, University of Verona, Verona, Italy

关键词: Exacerbations;    Bronchodilators;    Inhaled corticosteroids;    COPD;   

Others  :  1146644
DOI  :  10.1186/1465-9921-15-77

 received in 2014-01-15, accepted in 2014-06-16,  发布年份 2014

【 摘 要 】

Background

It has been suggested that withdrawal of inhaled corticosteroids (ICS) in COPD patients on maintenance treatment results in deterioration of symptoms, lung function and exacerbations. The aim of this real-life, prospective, multicentric study was to investigate whether withdrawal of ICS in COPD patients at low risk of exacerbation is linked to a deterioration in lung function and symptoms and to a higher frequency of exacerbations.

Methods

914 COPD patients, on maintenance therapy with bronchodilators and ICS, FEV₁>50% predicted, and <2 exacerbations/year were recruited. Upon decision of the primary physicians, 59% of patients continued their ICS treatment whereas in 41% of patients ICS were withdrawn and regular therapy was continued with long-acting bronchodilators mostly (91% of patients). FEV₁, CAT (COPD Assessment Test), and occurrence of exacerbations were measured at the beginning (T0) and at the end (T6) of the 6 months observational period.

Results

816 patients (89.3%) concluded the study. FEV₁, CAT and exacerbations history were similar in the two groups (ICS and no ICS) at T0 and at T6. We did not observe any deterioration of lung function symptoms, and exacerbation rate between the two groups at T0 and T6.

Conclusions

We conclude that the withdrawal of ICS, in COPD patients at low risk of exacerbation, can be safe provided that patients are left on maintenance treatment with long-acting bronchodilators.

【 授权许可】

   
2014 Rossi et al.; licensee BioMed Central Ltd.

【 图 表 】

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【 参考文献 】

• [1]Murray CJL, Lopez AD: Measuring the global burden of disease. New Eng J Med 2013, 369:448-457.
• [2]Qaseem A, Wilt TJ, Weinberger SE, Hanania NA, Criner G, van der Molen T, Marciniuk DD, Denberg T, Schünemann H, Wedzicha W, MacDonald R, Shekelle P, American College of Physicians; American College of Chest Physicians; American Thoracic Society; European Respiratory Society: 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.
• [3]Wedzicha JA, Decramer M, Seemugal TA: The role of bronchodilator treatment in the prevention of exacerbations of COPD. Eur Respir J 2012, 40:1545-1554.
• [4]Vestbo J, Hurd SS, Agustí AG, Jones PW, Vogelmeier C, Anzueto A, Barnes PJ, Fabbri LM, Martinez FJ, Nishimura M, Stockley RA, Sin DD, Rodriguez-Roisin R: Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2013, 187:347-365.
• [5]Corrado A, Rossi A: How far is real life from COPD therapy guidelines? An Italian observational study. Respir Med 2012, 106:989-997.
• [6]Roche N, Lepage T, Bourcereau J, Terrioux P: Guidelines versus clinical practice in the treatment of chronic obstructive pulmonary disease. Eur Respir J 2001, 18:903-908.
• [7]Seaman J, Leonard AC, Panos RJ: Health care utilization history, GOLD guidelines, and respiratory medication prescriptions in patients with COPD. Int J COPD 2010, 5:89-97.
• [8]Rabe KF, Hurd S, Anzueto A, Barnes PJ, Buist SA, Calverley P, Fukuchi Y, Jenkins C, Rodriguez-Roisin R, van Weel C, Zielinski J: Global initiative for chronic obstructive lung disease: global strategies for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2007, 176:532-555.
• [9]National Clinical Guideline Centre: Chronic Obstructive Pulmonary Disease: Management Of Chronic Obstructive Pulmonary Disease In Adults In Primary And Secondary Care. London, UK: National Clinical Guideline Centre; Available from: https://www.nice.org.uk/guidance/CG101/chapter/Introduction webcite.
• [10]Miravitlles M, Soler-Cataluña JJ, Calle M, Soriano JB: Treatment of COPD by clinical phenotypes: putting old evidence into clinical practice. Eur Respir J 2013, 41:1252-1256.
• [11]Agarwal R, Aggarwal AN, Gupta D, Jindal SK: Inhaled corticosteroids vs placebo for preventing COPD exacerbations: a systematic review and metaregression of randomized controlled trial. Chest 2010, 137:318-325.
• [12]Price D, Yawn B, Brusselle G, Rossi A: Risk-to-benefit ratio of inhaled corticosteroids in patients with COPD. Prim Care Respir J 2013, 22:92-100.
• [13]Calverley PM, Anderson JA, Celli B, Ferguson GT, Jenkins C, Jones PW, Yates JC, Vestbo J: TORCH investigators: salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N Engl J Med 2007, 356:775-789.
• [14]Suissa S: Number needed to treat in COPD: exacerbations versus pneumonias. Thorax 2013, 68:540-543.
• [15]Larsson K, Janson C, Lisspers K, Jørgensen L, Stratelis G, Telg G, Ställberg B, Johansson G: Combination of budesonide/formoterol more effective than fluticasone/salmeterol in preventing exacerbations in chronic obstructive pulmonary disease: the PATHOS study. J Intern Med 2013, 273:584-594.
• [16]Yawn BP, Li YF, Tian HJ, Zhang J, Arcona S, Kahler KH: Inhaled corticosteroid use in patients with chronic obstructive pulmonary disease and the risk of pneumonia: a retrospective claims data analysis. Int J COPD 2013, 8:295-304.
• [17]O’Brien A, Russo-Magno P, Karki A, Hiranniramol S, Hardin M, Kaszuba M, Sherman C, Rounds S: Effects of withdrawal of inhaled steroids in men with severe irreversible airflow obstruction. Am J Respir Crit Care Med 2001, 164:365-371.
• [18]van der Valk P, Monninkhof E, van der Palen J, Zielhuis G, van Herwaarden C: Effect of discontinuation of inhaled corticosteroids in patients with chronic obstructive pulmonary disease: the COPE study. Am J Respir Crit Care Med 2002, 166:1358-1363.
• [19]Choudhury AB, Dawson CM, Kilvington HE, Eldridge S, James WY, Wedzicha JA, Feder GS, Griffiths CJ: Withdrawal of inhaled corticosteroids in people with COPD in primary care: a randomized controlled trial. Respir Res 2007, 8:93.
• [20]Wouters EF, Postma DS, Fokkens B, Hop WC, Prins J, Kuipers AF, Pasma HR, Hensing CA, Creutzberg EC: COSMIC (COPD and seretide: a multi-center intervention and characterization) study group: withdrawal of fluticasone propionate from combined salmeterol/fluticasone treatment in patients with COPD causes immediate and sustained disease deterioration: a randomized controlled trial. Thorax 2005, 60:480-487.
• [21]Sin DD, Man SFP: Steroids in COPD: still up in the air? Eur Respir J 2010, 35:949-951.
• [22]Bettoncelli G, Blasi F, Brusasco V, Centanni S, Corrado A, De Benedetto F, De Michele F, Di Maria GU, Donner CF, Falcone F, Mereu C, Nardini S, Pasqua F, Polverino M, Rossi A, Sanguinetti CM: The clinical and integrated management of COPD. An official document of AIMAR (Interdisciplinary Association for research in Lung Disease), AIPO (Italian Association of Hospital Pulmonologists), SIMER (Italian Society of Respiratory Medicine), SIMG (Italian Society of General Medicine). Sarcoidosis Vasc Diffuse Lung Dis 2014, 31(Suppl 1):3-21.
• [23]Siafakas NM, Vermeire P, Pride NB, Paoletti P, Gibson J, Howard P, Yernault JC, Decramer M, Higenbottam T, Postma DS, Rees J, On behalf of the Task Force: Optimal assessment and management of chronic obstructive pulmonary disease (COPD). A consensus statement of the European respiratory society (ERS). Eur Respir J 1995, 8:1398-1420.
• [24]Pellegrino R, Viegi G, Brusasco V, Crapo RO, Burgos F, Casaburi R, Coates A, van der Grinten CP, Gustafsson P, Hankinson J, Jensen R, Johnson DC, MacIntyre N, McKay R, Miller MR, Navajas D, Pedersen OF, Wanger J: Interpretative strategies for lung function tests. Eur Respir J 2005, 26:948-968.
• [25]Enright P, Brusasco V: Counterpoint: should we abandon FEV1/FVC, 0.70 to detect airway obstruction? Yes. Chest 2010, 138:1040-1042.
• [26]Quanjer PH, Tammeling GJ, Cotes JE, Pedersen OF, Peslin R, Yernault JC: Lung volumes and ventilator flows. Report working party “standardization of lung function tests”. European community for steel and coal and European respiratory Society. Eur Respir J 1993, 6(Suppl.16):5-40.
• [27]Hurst JR, Vestbo J, Anzueto A, Locantore N, Müllerova H, Tal-Singer R, Miller B, Lomas DA, Agusti A, Macnee W, Calverley P, Rennard S, Wouters EF, Wedzicha JA: Evaluation of COPD longitudinally to identify predictive surrogate endpoints (ECLIPSE) investigators: susceptibility to exacerbation in chronic obstructive pulmonary disease. N Engl J Med 2010, 363:1128-1138.
• [28]Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy N: Development and first validation of the COPD assessment test. Eur Respir J 2009, 34:648-654.
• [29]Ofir D, Laveneziana P, Webb KA, Lam YM, O’Donnell DE: Mechanisms of dyspnea during cycle exercise in symptomatic patients with GOLD stage I chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2008, 177:622-629.
• [30]Decramer M, Celli B, Kesten S, Lystig T, Mehra S, Tashkin DP: UPLIFT investigators: effect of tiotropium on outcomes in patients with moderate chronic obstructive pulmonary disease (UPLIFT): a prespecified subgroup analysis of a randomized controlled trial. Lancet 2009, 374:1171-1178.
• [31]Nadeem NJ, Taylor SJC, Eldridge SM: Withdrawal of inhaled corticosteroids in individuals with COPD – a systematic review and comment on trial methodology. Respir Res 2011, 12:107.
• [32]Mahler DA, D’Urzo A, Bateman ED, Ozkan SA, White T, Peckitt C, Lassen C, Kramer B: INTRUST-1 and INTRUST-2 study investigators: 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.
• [33]Vogelmeier CF, Bateman ED, Pallante J, Alagappan VKT, D’Andrea P, Chen H, Banerji D: 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, 1:51-60.