Email this article Indacaterol and salmeterol in COPD patients: a comparative study of efficacy and safety
Abstract
Background: Chronic obstructive pulmonary disease (COPD) is an airway disorder characterized by airflow limitation that is not fully reversible. Indacaterol is a novel, inhaled, once-daily, ultra-long-acting β2-agonist bronchodilator recently approved in India for the treatment of chronic obstructive pulmonary disease (COPD). The aim of the present study was to investigate the efficacy and safety of indacaterol compared to twice-daily β2-agonist, salmeterol, as an active control.
Methods: The present study was open, randomized parallel group comparison of two active treatment groups over a 12 week period. A total of 60 patients with moderate-to-severe COPD were randomised to treatment either with indacaterol (150 μg once daily) or with salmeterol (50 μg twice daily) and 51 (85%) patients completed the study. The efficacy parameters were change in FEV1, health related quality of life by measuring St George’s Respiratory Questionnaire (SGRQ) total score and severity of dyspnoea as measured by Transition Dyspnoea Index (TDI) score which were assessed at baseline first and at weeks 4, 8 and 12.
Results: Indacaterol increased FEV1 at week 4 by 50 ml, at week 8 and at week 12 by 60 ml over salmeterol and the increase was highly significant (p<0.001) at all stages of the study. Both treatments improved health status (SGRQ total score) and dyspnoea (TDI score), with differences between them favouring indacaterol. Safety profiles were similar across the treatment groups, and both indacaterol and salmeterol were well tolerated without any severe adverse events.
Conclusions: Once-daily treatment with 150 μg indacaterol had a significant and clinically relevant bronchodilator effect and improved health status and dyspnoea to a greater extent than twice-daily 50 μg salmeterol. Indacaterol should prove a useful addition in the treatment of patients with COPD.
Keywords
Full Text:
PDFReferences
Mannino DM, Buist AS. Global burden of COPD: risk factors, prevalence, and future trends. Lancet 2007; 370: 765–773.
Vermeire P. The burden of chronic obstructive pulmonary disease. Respir Med 2002;96:S3-10.
Jindal SK, Aggarwal AN, Gupta D. A review of population studies from India to estimate national burden of chronic obstructive pulmonary disease and its association with smoking. Indian J Chest Dis Allied Sci 2001;43:139-47.
Sunyer J, Schwartz J, Tobias A, Macfarlane D, Garcia J, Anto JM. Patients with chronic obstructive pulmonary disease are at increased risk of death associated with urban particle air pollution: A case-crossover analysis. Am J Epidemiol 2000;151:50-6.
Smith KR, Mehta S. The burden of disease from indoor air pollution in developing countries: Comparison of estimates. Int J Hyg Environ Health 2003;206:279-89.
Chhabra SK, Chhabra P, Rajpal S, Gupta RK. Ambient air pollution and chronic respiratory morbidity in Delhi. Arch Environ Health 2001;56:58-64.
Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. www.goldcopd.com/ GuidelineItem.asp?intId=1386 Date last accessed: January 17, 2010. Date last updated: 2009.
Feldman G, Siler T, Prasad N, et al. Efficacy and safety of indacaterol 150 microg once-daily in COPD: a double-blind, randomised, 12-week study. BMC Pulm Med. 2010;10:11
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;65:473–479.
Donohue JF, Fogarty C, Lötvall J, et al. INHANCE Study Investigators. Once-daily bronchodilators for chronic obstructive pulmonary disease: indacaterol versus tiotropium. Am J Respir Crit Care Med. 2010;182:155–162.
Jones PW, Quirk FH, Baveystock CM, et al. A self-complete measure of health status for chronic airflow limitation. The St. George's Respiratory Questionnaire. Am Rev Respir Dis 1992; 145: 1321–1327.
Jones PW. St. George's Respiratory Questionnaire: MCID. COPD 2005; 2: 75–79.
Mahler DA, Weinberg DH, Wells CK, et al. The measurement of dyspnea. Contents, interobserver agreement, and physiologic correlates of two new clinical indexes. Chest 1984; 85: 751–758.
Witek TJ Jr., Mahler DA. Minimal important difference of the transition dyspnoea index in a multinational clinical trial. Eur Respir J 2003; 21: 267–272.
Common Toxicity Criteria (CTC) Version 2.0. Available from: http://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/ctcv20_4-30-992.pdf. [Last accessed on 1999 Apr 30].
Mahler DA, Donohue JF, Barbee RA, et al. Efficacy of salmeterol xinafoate in the treatment of COPD. Chest 1999; 115: 957–965.
Hodder R, Kesten S, Menjoge S, et al. Outcomes in COPD patients receiving tiotropium or salmeterol plus treatment with inhaled corticosteroids. Int J Chron Obstruct Pulmon Dis 2007; 2: 157–167.
Donohue JF, van Noord JA, Bateman ED, et al. A 6-month, placebo-controlled study comparing lung function and health status changes in COPD patients treated with tiotropium or salmeterol. Chest 2002; 122: 47–55.
Hanania NA, Darken P, Horstman D, et al. The efficacy and safety of fluticasone propionate (250 μg)/salmeterol (50 μg) combined in the Diskus inhaler for the treatment of COPD. Chest 2003; 124: 834–843.
Partridge MR, Karlsson N, Small IR. Patient insight into the impact of chronic obstructive pulmonary disease in the morning: an internet survey. Curr Med Res Opin 2009; 25: 2043–2048.
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: 741–750.
ZuWallack RL, Mahler DA, Reilly D, et al. Salmeterol plus theophylline combination therapy in the treatment of COPD. Chest 2001; 119: 1661–1670.
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: 449–456.
Celli BR, Cote CG, Marin JM, et al. The body-mass index, airflow obstruction, dyspnea, and exercise capacity index in chronic obstructive pulmonary disease. N Engl J Med 2004; 350: 1005–1012.
Sin DD, Anthonisen NR, Soriano JB, et al. Mortality in COPD: role of comorbidities. Eur Respir J 2006; 28: 1245–1257.
Barnes PJ, Celli BR. Systemic manifestations and comorbidities of COPD. Eur Respir J 2009; 33: 1165–1185.
Huiart L, Ernst P, Suissa S. Cardiovascular morbidity and mortality in COPD. Chest 2005; 128: 2640–2646.
Rennard S, Bantje T, Centanni S, et al. A dose-ranging study of indacaterol in obstructive airways disease, with a tiotropium comparison. Respir Med 2008; 102: 1033–1044.
Beier J, Chanez P, Martinot JB, et al. Safety, tolerability and efficacy of indacaterol, a novel once-daily b2-agonist, in patients with COPD: a 28-day randomised, placebo controlled clinical trial. Pulm Pharmacol Ther 2007; 20: 740–749.
