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Published in: BMC Pulmonary Medicine 1/2015

Open Access 01-12-2015 | Research article

Reliever salbutamol use as a measure of exacerbation risk in chronic obstructive pulmonary disease

Authors: Christine R. Jenkins, Dirkje S. Postma, Antonio R. Anzueto, Barry J. Make, Stefan Peterson, Göran Eriksson, Peter M. Calverley

Published in: BMC Pulmonary Medicine | Issue 1/2015

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Abstract

Background

Debate exists regarding which endpoints most sensitively reflect day-to-day variation in chronic obstructive pulmonary disease (COPD) symptoms and are most useful in clinical practice to predict COPD exacerbations. We hypothesized that short-acting β2-agonist (SABA) reliever use would predict short- and long-term exacerbation risk in COPD patients.

Methods

We performed a retrospective analysis of data from a study (ClinicalTrials.gov registration: NCT00419744) comparing budesonide/formoterol 320/9 μg with formoterol 9 μg (both twice daily) in patients with moderate-to-very-severe COPD; reliever salbutamol 90 μg was provided. First occurrence of reliever use >4 (low), >10 (medium), and >20 (high) inhalations/day was assessed as a predictor of short-term (3-week) exacerbation risk. Mean daily reliever use in the week preceding the 2-month visit was investigated as a predictor of the long-term (10-month) exacerbation risk, using intervals of 2–5, 6–9, and ≥10 inhalations/day.

Results

Overall, 810 patients were included (61 % male; mean age 63.2 years; post-bronchodilator forced expiratory volume in 1 s 37.7 % of predicted). First occurrence of low, medium, or high reliever use was predictive of an exacerbation within the following 3 weeks; exacerbation risk increased significantly with increasing reliever use. Mean reliever use over 1 week was predictive of long-term exacerbation risk. Patients with mean use of 2–5, 6–9, and ≥10 inhalations/day exhibited 21 %, 67 %, and 135 % higher exacerbation rates, respectively, in the following 10 months, compared with <2 inhalations/day. Budesonide/formoterol was associated with lower short- and long-term exacerbation risk than formoterol in all reliever-use groups.

Conclusions

SABA reliever use is a predictor of short- and long-term exacerbation risk in moderate-to-very-severe COPD patients with a history of exacerbations receiving budesonide/formoterol or formoterol.
Literature
1.
go back to reference Vos T, Flaxman AD, Naghavi M, Lozano R, Michaud C, Ezzati M, et al. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990–2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012;380(9859):2163–96.CrossRefPubMed Vos T, Flaxman AD, Naghavi M, Lozano R, Michaud C, Ezzati M, et al. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990–2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012;380(9859):2163–96.CrossRefPubMed
2.
go back to reference Yeatts KB, Lippmann SJ, Waller AE, Hassmiller Lich K, Travers D, Weinberger M, et al. Population-based burden of COPD-related visits in the ED: return ED visits, hospital admissions, and comorbidity risks. Chest. 2013;144(3):784–93.CrossRefPubMedPubMedCentral Yeatts KB, Lippmann SJ, Waller AE, Hassmiller Lich K, Travers D, Weinberger M, et al. Population-based burden of COPD-related visits in the ED: return ED visits, hospital admissions, and comorbidity risks. Chest. 2013;144(3):784–93.CrossRefPubMedPubMedCentral
3.
go back to reference Postma D, Anzueto A, Calverley P, Jenkins C, Make BJ, Sciurba FC, et al. A new perspective on optimal care for patients with COPD. Prim Care Respir J. 2011;20(2):205–9.CrossRefPubMed Postma D, Anzueto A, Calverley P, Jenkins C, Make BJ, Sciurba FC, et al. A new perspective on optimal care for patients with COPD. Prim Care Respir J. 2011;20(2):205–9.CrossRefPubMed
5.
go back to reference Westwood M, Bourbeau J, Jones PW, Cerulli A, Capkun-Niggli G, Worthy G. Relationship between FEV1 change and patient-reported outcomes in randomised trials of inhaled bronchodilators for stable COPD: a systematic review. Respir Res. 2011;12:40.CrossRefPubMedPubMedCentral Westwood M, Bourbeau J, Jones PW, Cerulli A, Capkun-Niggli G, Worthy G. Relationship between FEV1 change and patient-reported outcomes in randomised trials of inhaled bronchodilators for stable COPD: a systematic review. Respir Res. 2011;12:40.CrossRefPubMedPubMedCentral
6.
go back to reference Jones PW, Quirk FH, Baveystock CM, Littlejohns P. A self-complete measure of health status for chronic airflow limitation. The St. George’s Respiratory Questionnaire. Am Rev Respir Dis. 1992;145(6):1321–7.CrossRefPubMed Jones PW, Quirk FH, Baveystock CM, Littlejohns P. A self-complete measure of health status for chronic airflow limitation. The St. George’s Respiratory Questionnaire. Am Rev Respir Dis. 1992;145(6):1321–7.CrossRefPubMed
7.
go back to reference Cazzola M, MacNee W, Martinez FJ, Rabe KF, Franciosi LG, Barnes PJ, et al. Outcomes for COPD pharmacological trials: from lung function to biomarkers. Eur Respir J. 2008;31(2):416–69.CrossRefPubMed Cazzola M, MacNee W, Martinez FJ, Rabe KF, Franciosi LG, Barnes PJ, et al. Outcomes for COPD pharmacological trials: from lung function to biomarkers. Eur Respir J. 2008;31(2):416–69.CrossRefPubMed
8.
go back to reference Landis SH, Muellerova H, Mannino DM, Menezes AM, Han MK, van der Molen T, et al. Continuing to confront COPD international patient survey: methods, COPD prevalence, and disease burden in 2012–2013. Int J Chron Obstruct Pulmon Dis. 2014;9:597–611.PubMedPubMedCentral Landis SH, Muellerova H, Mannino DM, Menezes AM, Han MK, van der Molen T, et al. Continuing to confront COPD international patient survey: methods, COPD prevalence, and disease burden in 2012–2013. Int J Chron Obstruct Pulmon Dis. 2014;9:597–611.PubMedPubMedCentral
9.
go back to reference Bateman ED, Reddel HK, Eriksson G, Peterson S, Ostlund O, Sears MR, et al. Overall asthma control: the relationship between current control and future risk. J Allergy Clin Immunol. 2010;125(3):600–8.CrossRefPubMed Bateman ED, Reddel HK, Eriksson G, Peterson S, Ostlund O, Sears MR, et al. Overall asthma control: the relationship between current control and future risk. J Allergy Clin Immunol. 2010;125(3):600–8.CrossRefPubMed
10.
go back to reference Melosini L, Dente FL, Bacci E, Bartoli ML, Cianchetti S, Costa F, et al. Asthma control test (ACT): comparison with clinical, functional, and biological markers of asthma control. J Asthma. 2012;49(3):317–23.CrossRefPubMed Melosini L, Dente FL, Bacci E, Bartoli ML, Cianchetti S, Costa F, et al. Asthma control test (ACT): comparison with clinical, functional, and biological markers of asthma control. J Asthma. 2012;49(3):317–23.CrossRefPubMed
11.
go back to reference Revicki D, Weiss KB. Clinical assessment of asthma symptom control: review of current assessment instruments. J Asthma. 2006;43(7):481–7.CrossRefPubMed Revicki D, Weiss KB. Clinical assessment of asthma symptom control: review of current assessment instruments. J Asthma. 2006;43(7):481–7.CrossRefPubMed
12.
go back to reference Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management and prevention of chronic obstructive pulmonary disease. Updated 2014 [http://www.goldcopd.com/] Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management and prevention of chronic obstructive pulmonary disease. Updated 2014 [http://​www.​goldcopd.​com/​]
13.
go back to reference Vestbo J, Hurd SS, Agusti AG, Jones PW, Vogelmeier C, Anzueto A, et al. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2013;187(4):347–65.CrossRefPubMed Vestbo J, Hurd SS, Agusti AG, Jones PW, Vogelmeier C, Anzueto A, et al. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2013;187(4):347–65.CrossRefPubMed
14.
go back to reference Kessler R, Partridge MR, Miravitlles M, Cazzola M, Vogelmeier C, Leynaud D, et al. Symptom variability in patients with severe COPD: a pan-European cross-sectional study. Eur Respir J. 2011;37(2):264–72.CrossRefPubMed Kessler R, Partridge MR, Miravitlles M, Cazzola M, Vogelmeier C, Leynaud D, et al. Symptom variability in patients with severe COPD: a pan-European cross-sectional study. Eur Respir J. 2011;37(2):264–72.CrossRefPubMed
15.
go back to reference Cook D, Guyatt G, Wong E, Goldstein R, Bedard M, Austin P, et al. Regular versus as-needed short-acting inhaled beta-agonist therapy for chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2001;163(1):85–90.CrossRefPubMed Cook D, Guyatt G, Wong E, Goldstein R, Bedard M, Austin P, et al. Regular versus as-needed short-acting inhaled beta-agonist therapy for chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2001;163(1):85–90.CrossRefPubMed
16.
go back to reference 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):257–68.CrossRefPubMed 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):257–68.CrossRefPubMed
17.
go back to reference Welte T, Miravitlles M, Hernandez P, Eriksson G, Peterson S, Polanowski T, 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):741–50.CrossRefPubMed Welte T, Miravitlles M, Hernandez P, Eriksson G, Peterson S, Polanowski T, 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):741–50.CrossRefPubMed
18.
go back to reference Donohue JF, Fogarty C, Lotvall J, Mahler DA, Worth H, Yorgancioglu A, et al. Once-daily bronchodilators for chronic obstructive pulmonary disease: indacaterol versus tiotropium. Am J Respir Crit Care Med. 2010;182(2):155–62.CrossRefPubMed Donohue JF, Fogarty C, Lotvall J, Mahler DA, Worth H, Yorgancioglu A, et al. Once-daily bronchodilators for chronic obstructive pulmonary disease: indacaterol versus tiotropium. Am J Respir Crit Care Med. 2010;182(2):155–62.CrossRefPubMed
19.
go back to reference D’Urzo A, Ferguson GT, van Noord JA, Hirata K, Martin C, Horton R, et al. Efficacy and safety of once-daily NVA237 in patients with moderate-to-severe COPD: the GLOW1 trial. Respir Res. 2011;12:156.CrossRefPubMedPubMedCentral D’Urzo A, Ferguson GT, van Noord JA, Hirata K, Martin C, Horton R, et al. Efficacy and safety of once-daily NVA237 in patients with moderate-to-severe COPD: the GLOW1 trial. Respir Res. 2011;12:156.CrossRefPubMedPubMedCentral
20.
go back to reference Fuhr R, Magnussen H, Sarem K, Llovera AR, Kirsten AM, Falques M, et al. Efficacy of aclidinium bromide 400 mug twice daily compared with placebo and tiotropium in patients with moderate to severe COPD. Chest. 2012;141(3):745–52.CrossRefPubMed Fuhr R, Magnussen H, Sarem K, Llovera AR, Kirsten AM, Falques M, et al. Efficacy of aclidinium bromide 400 mug twice daily compared with placebo and tiotropium in patients with moderate to severe COPD. Chest. 2012;141(3):745–52.CrossRefPubMed
21.
go back to reference Vogelmeier C, Hederer B, Glaab T, Schmidt H, Rutten-van Molken MP, Beeh KM, et al. Tiotropium versus salmeterol for the prevention of exacerbations of COPD. N Engl J Med. 2011;364(12):1093–103.CrossRefPubMed Vogelmeier C, Hederer B, Glaab T, Schmidt H, Rutten-van Molken MP, Beeh KM, et al. Tiotropium versus salmeterol for the prevention of exacerbations of COPD. N Engl J Med. 2011;364(12):1093–103.CrossRefPubMed
22.
go back to reference Buhl R, Kuna P, Peters MJ, Andersson TL, Naya IP, Peterson S, et al. The effect of budesonide/formoterol maintenance and reliever therapy on the risk of severe asthma exacerbations following episodes of high reliever use: an exploratory analysis of two randomised, controlled studies with comparisons to standard therapy. Respir Res. 2012;13:59.CrossRefPubMedPubMedCentral Buhl R, Kuna P, Peters MJ, Andersson TL, Naya IP, Peterson S, et al. The effect of budesonide/formoterol maintenance and reliever therapy on the risk of severe asthma exacerbations following episodes of high reliever use: an exploratory analysis of two randomised, controlled studies with comparisons to standard therapy. Respir Res. 2012;13:59.CrossRefPubMedPubMedCentral
23.
go back to reference Tashkin DP, Rennard SI, Martin P, Ramachandran S, Martin UJ, Silkoff PE, 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.CrossRefPubMed Tashkin DP, Rennard SI, Martin P, Ramachandran S, Martin UJ, Silkoff PE, 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.CrossRefPubMed
24.
go back to reference Rennard SI, Tashkin DP, McElhattan J, Goldman M, Ramachandran S, Martin UJ, 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):549–65.CrossRefPubMedPubMedCentral Rennard SI, Tashkin DP, McElhattan J, Goldman M, Ramachandran S, Martin UJ, 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):549–65.CrossRefPubMedPubMedCentral
25.
go back to reference 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):912–9.CrossRefPubMed 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):912–9.CrossRefPubMed
26.
go back to reference Szafranski W, Cukier A, Ramirez A, Menga G, Sansores R, Nahabedian S, et al. Efficacy and safety of budesonide/formoterol in the management of chronic obstructive pulmonary disease. Eur Respir J. 2003;21(1):74–81.CrossRefPubMed Szafranski W, Cukier A, Ramirez A, Menga G, Sansores R, Nahabedian S, et al. Efficacy and safety of budesonide/formoterol in the management of chronic obstructive pulmonary disease. Eur Respir J. 2003;21(1):74–81.CrossRefPubMed
27.
go back to reference Make BJ, Eriksson GS, Calverley PM, Jenkins C, Postma DS, Peterson S, et al. A score to predict short-term risk of COPD exacerbations (SCOPEX). Int J Chron Obstruct Pulmon Dis. 2015;10:201–9.CrossRefPubMedPubMedCentral Make BJ, Eriksson GS, Calverley PM, Jenkins C, Postma DS, Peterson S, et al. A score to predict short-term risk of COPD exacerbations (SCOPEX). Int J Chron Obstruct Pulmon Dis. 2015;10:201–9.CrossRefPubMedPubMedCentral
28.
go back to reference Juniper EF, Bousquet J, Abetz L, Bateman ED. Identifying’well-controlled’ and ’not well-controlled’ asthma using the Asthma Control Questionnaire. Respir Med. 2006;100(4):616–21. Juniper EF, Bousquet J, Abetz L, Bateman ED. Identifying’well-controlled’ and ’not well-controlled’ asthma using the Asthma Control Questionnaire. Respir Med. 2006;100(4):616–21.
29.
go back to reference Juniper EF, Langlands JM, Juniper BA. Patients may respond differently to paper and electronic versions of the same questionnaires. Respir Med. 2009;103(6):932–4.CrossRefPubMed Juniper EF, Langlands JM, Juniper BA. Patients may respond differently to paper and electronic versions of the same questionnaires. Respir Med. 2009;103(6):932–4.CrossRefPubMed
Metadata
Title
Reliever salbutamol use as a measure of exacerbation risk in chronic obstructive pulmonary disease
Authors
Christine R. Jenkins
Dirkje S. Postma
Antonio R. Anzueto
Barry J. Make
Stefan Peterson
Göran Eriksson
Peter M. Calverley
Publication date
01-12-2015
Publisher
BioMed Central
Published in
BMC Pulmonary Medicine / Issue 1/2015
Electronic ISSN: 1471-2466
DOI
https://doi.org/10.1186/s12890-015-0077-0

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