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Review

A review of current and developing fixed-dose LABA/LAMA combinations for treating COPD

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Pages 1833-1843 | Received 04 Jul 2017, Accepted 07 Nov 2017, Published online: 15 Nov 2017

References

  • Global strategy for the diagnosis, management and prevention of COPD, global initiative for chronic obstructive lung disease (GOLD). 2017. Available from: http://goldcopd.org.
  • Lozano R, Naghavi M, Foreman K, et al. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012;380(9859):2095–2128.
  • Montuschi P, Ciabattoni G. Bronchodilating drugs for chronic obstructive pulmonary disease: current status and future trends. J Med Chem. 2015;58(10):4131–4164.
  • Sibila O, Soto-Gomez N, Restrepo MI. The risk and outcomes of pneumonia in patients on inhaled corticosteroids. Pulm Pharmacol Ther. 2015;32:130–136.
  • Fuso L, Mores N, Valente S, et al. Long-acting beta-agonists and their association with inhaled corticosteroids in COPD. Curr Med Chem. 2013;20(12):1477–1495.
  • Cazzola M, Page CP, Calzetta L, et al. Pharmacology and therapeutics of bronchodilators. Pharmacol Rev. 2012;64(3):450–504.
  • Baur F, Beattie D, Beer D, et al. The identification of indacaterol as an ultralong-acting inhaled beta2-adrenoceptor agonist. J Med Chem. 2010;53(9):3675–3684.
  • Bouyssou T, Hoenke C, Rudolf K, et al. Discovery of olodaterol, a novel inhaled beta2-adrenoceptor agonist with a 24 h bronchodilatory efficacy. Bioorg Med Chem Lett. 2010;20(4):1410–1414.
  • Slack RJ, Barrett VJ, Morrison VS, et al. In vitro pharmacological characterization of vilanterol, a novel long-acting beta2-adrenoceptor agonist with 24-hour duration of action. J Pharmacol Exp Ther. 2013;344(1):218–230.
  • Tashkin DP, Celli B, Senn S, et al. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med. 2008;359(15):1543–1554.
  • Tashkin DP, Ferguson GT. Combination bronchodilator therapy in the management of chronic obstructive pulmonary disease. Respir Res. 2013;14:49.
  • Spina D. Pharmacology of novel treatments for COPD: are fixed dose combination LABA/LAMA synergistic? Eur Clin Respir J. 2015 Mar 16;2.
  • Smit M, Zuidhof AB, Bos SI, et al. Bronchoprotection by olodaterol is synergistically enhanced by tiotropium in a guinea pig model of allergic asthma. J Pharmacol Exp Ther. 2014;348(2):303–310.
  • Rossoni G, Manfredi B, Razzetti R, et al. Positive interaction of the novel beta2-agonist carmoterol and tiotropium bromide in the control of airway changes induced by different challenges in guinea-pigs. Pulm Pharmacol Ther. 2007;20(3):250–257.
  • Calzetta L, Rogliani P, Mattei M, et al. Pharmacological characterization of the interaction between tiotropium and olodaterol administered at 5:5 concentration-ratio in equine bronchi. Copd. 2017;14(5):526–532.
  • Cazzola M, Calzetta L, Segreti A, et al. Translational study searching for synergy between glycopyrronium and indacaterol. Copd. 2015;12(2):175–181.
  • Cazzola M, Calzetta L, Puxeddu E, et al. Pharmacological characterisation of the interaction between glycopyrronium bromide and indacaterol fumarate in human isolated bronchi, small airways and bronchial epithelial cells. Respir Res. 2016;17(1):70.
  • Cazzola M, Calzetta L, Ora J, et al. Searching for the synergistic effect between aclidinium and formoterol: from bench to bedside. Respir Med. 2015;109(10):1305–1311.
  • Calzetta L, Rogliani P, Facciolo F, et al. Pharmacological characterization of the interaction between umeclidinium and vilanterol in human bronchi. Eur J Pharmacol. 2017;812:147–154.
  • Calzetta L, Matera MG, Cazzola M. Pharmacological interaction between LABAs and LAMAs in the airways: optimizing synergy. Eur J Pharmacol. 2015;761:168–173.
  • Ficker JH, Rabe KF, Welte T. Role of dual bronchodilators in COPD: a review of the current evidence for indacaterol/glycopyrronium. Pulm Pharmacol Ther. 2017;45:19–33.
  • Thomason MJ, Strachan DP. Which spirometric indices best predict subsequent death from chronic obstructive pulmonary disease? Thorax. 2000;55(9):785–788.
  • McCartney CT, Weis MN, Ruppel GL, et al. Residual volume and total lung capacity to assess reversibility in obstructive lung disease. Respir Care. 2016;61(11):1505–1512.
  • Faisal A, Alghamdi BJ, Ciavaglia CE, et al. Common mechanisms of dyspnea in chronic interstitial and obstructive lung disorders. Am J Respir Crit Care Med. 2016;193(3):299–309.
  • Vestbo J, Anderson W, Coxson HO, et al. Evaluation of COPD longitudinally to identify predictive surrogate end-points (ECLIPSE). Eur Respir J. 2008;31(4):869–873.
  • Buhl R, Maltais F, Abrahams R, et al. Tiotropium and olodaterol fixed-dose combination versus mono-components in COPD (GOLD 2-4). Eur Respir J. 2015;45(4):969–979.
  • Singh D, Jones PW, Bateman ED, et al. Efficacy and safety of aclidinium bromide/formoterol fumarate fixed-dose combinations compared with individual components and placebo in patients with COPD (ACLIFORM-COPD): a multicentre, randomised study. BMC Pulm Med. 2014;14:178.
  • D’Urzo AD, Rennard SI, Kerwin EM, et al. Efficacy and safety of fixed-dose combinations of aclidinium bromide/formoterol fumarate: the 24-week, randomized, placebo-controlled AUGMENT COPD study. Respir Res. 2014;15:123.
  • Donohue JF, Maleki-Yazdi MR, Kilbride S, et al. Efficacy and safety of once-daily umeclidinium/vilanterol 62. 5/25mcg in COPD. Respiratory Medicine. 2013;107(10):1538–1546.
  • Maleki-Yazdi MR, Kaelin T, Richard N, et al. Efficacy and safety of umeclidinium/vilanterol 62.5/25mcg and tiotropium 18 mcg in chronic obstructive pulmonary disease: results of a 24-week, randomized, controlled trial. Respiratory Medicine. 2014;108(12):1752–1760.
  • Bateman ED, Ferguson GT, Barnes N, et al. Dual bronchodilation with QVA149 versus single bronchodilator therapy: the SHINE study. Eur Respir J. 2013;42(6):1484–1494.
  • Dahl R, Chapman KR, Rudolf M, et al. Safety and efficacy of dual bronchodilation with QVA149 in COPD patients: the ENLIGHTEN study. Respir Med. 2013;107(10):1558–1567.
  • Wedzicha JA, Decramer M, Ficker JH, et al. Analysis of chronic obstructive pulmonary disease exacerbations with the dual bronchodilator QVA149 compared with glycopyrronium and tiotropium (SPARK): a randomised, double-blind, parallel-group study. Lancet Respir Med. 2013;1(3):199–209.
  • Vogelmeier CF, Bateman ED, Pallante J, et al. 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(1):51–60.
  • Mahler DA, Kerwin E, Ayers T, et al. FLIGHT1 and FLIGHT2: efficacy and safety of QVA149 (Indacaterol/Glycopyrrolate) versus its monocomponents and placebo in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2015;192(9):1068–1079.
  • Vogelmeier CF, Gaga M, Aalamian-Mattheis M, et al. Efficacy and safety of direct switch to indacaterol/glycopyrronium in patients with moderate COPD: the CRYSTAL open-label randomised trial. Respir Res. 2017;18(1):140.
  • Martinez FJ, Rabe KF, Ferguson GT, et al. Efficacy and safety of glycopyrrolate/formoterol metered dose inhaler formulated using co-suspension delivery technology in patients with COPD. Chest. 2017;151(2):340–357.
  • Lal C, Strange C. Aclidinium bromide plus formoterol for the treatment of chronic obstructive pulmonary disease. Expert Opin Pharmacother. 2015;16(3):427–434.
  • Wedzicha JA, Banerji D, Chapman KR, et al. Indacaterol-glycopyrronium versus salmeterol-fluticasone for COPD. N Engl J Med. 2016;374(23):2222–2234.
  • Tashkin DP, Pearle J, Iezzoni D, et al. Formoterol and tiotropium compared with tiotropium alone for treatment of COPD. Copd. 2009;6(1):17–25.
  • Tashkin DP, Littner M, Andrews CP, et al. Concomitant treatment with nebulized formoterol and tiotropium in subjects with COPD: a placebo-controlled trial. Respir Med. 2008;102(4):479–487.
  • Tashkin DP, Donohue JF, Mahler DA, et al. Effects of arformoterol twice daily, tiotropium once daily, and their combination in patients with COPD. Respir Med. 2009;103(4):516–524.
  • Van Noord JA, Aumann JL, Janssens E, et al. Comparison of tiotropium once daily, formoterol twice daily and both combined once daily in patients with COPD. Eur Respir J. 2005;26(2):214–222.
  • Van Noord JA, Aumann JL, Janssens E, et al. Effects of tiotropium with and without formoterol on airflow obstruction and resting hyperinflation in patients with COPD. Chest. 2006;129(3):509–517.
  • Wang J, Jin D, Zuo P, et al. Comparison of tiotropium plus formoterol to tiotropium alone in stable chronic obstructive pulmonary disease: a meta-analysis. Respirology. 2011;16(2):350–358.
  • Horita N, Goto A, Shibata Y, et al. Long-acting muscarinic antagonist (LAMA) plus long-acting beta-agonist (LABA) versus LABA plus inhaled corticosteroid (ICS) for stable chronic obstructive pulmonary disease (COPD). Cochrane Database Syst Rev. 2017;2:CD012066.
  • Berton DC, Reis M, Siqueira AC, et al. Effects of tiotropium and formoterol on dynamic hyperinflation and exercise endurance in COPD. Respir Med. 2010;104(9):1288–1296.
  • Tashkin DP, Fabbri LM. Long-acting beta-agonists in the management of chronic obstructive pulmonary disease: current and future agents. Respir Res. 2010;11:149.
  • Salpeter SR, Buckley NS, Ormiston TM, et al. Meta-analysis: effect of long-acting beta-agonists on severe asthma exacerbations and asthma-related deaths. Ann Intern Med. 2006;144(12):904–912.
  • Salpeter SR, Ormiston TM, Salpeter EE. Cardiovascular effects of beta-agonists in patients with asthma and COPD: a meta-analysis. Chest. 2004;125(6):2309–2321.
  • Cazzola M, Matera MG, Donner CF. Inhaled beta2-adrenoceptor agonists: cardiovascular safety in patients with obstructive lung disease. Drugs. 2005;65(12):1595–1610.
  • Kesten S, Jara M, Wentworth C, et al. Pooled clinical trial analysis of tiotropium safety. Chest. 2006;130(6):1695–1703.
  • Yohannes AM, Willgoss TG, Vestbo J. Tiotropium for treatment of stable COPD: a meta-analysis of clinically relevant outcomes. Respir Care. 2011;56(4):477–487.
  • Singh S, Loke YK, Enright PL, et al. Mortality associated with tiotropium mist inhaler in patients with chronic obstructive pulmonary disease: systematic review and meta-analysis of randomised controlled trials. BMJ. 2011;342:d3215.
  • Kanner RE, Anthonisen NR, Connett JE; Lung Health Study Research G. Lower respiratory illnesses promote FEV(1) decline in current smokers but not ex-smokers with mild chronic obstructive pulmonary disease: results from the lung health study. Am J Respir Crit Care Med. 2001;164(3):358–364.
  • Seemungal TA, Donaldson GC, Paul EA, et al. Effect of exacerbation on quality of life in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1998;157(5 Pt 1):1418–1422.
  • Rennard SI, Farmer SG. Exacerbations and progression of disease in asthma and chronic obstructive pulmonary disease. Proc Am Thorac Soc. 2004;1(2):88–92.
  • Singh D. Evaluation of new drugs for asthma and COPD: endpoints, biomarkers and clinical trial design. Handb Exp Pharmacol. 2017;237:243–264.
  • 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.
  • Vestbo J, Anderson JA, Brook RD, et al. Fluticasone furoate and vilanterol and survival in chronic obstructive pulmonary disease with heightened cardiovascular risk (SUMMIT): a double-blind randomised controlled trial. Lancet. 2016;387(10030):1817–1826.
  • Calzetta L, Ora J, Cavalli F, et al. Impact of LABA/LAMA combination on exercise endurance and lung hyperinflation in COPD: a pair-wise and network meta-analysis. Respir Med. 2017;129:189–198.
  • Calzetta L, Rogliani P, Ora J, et al. LABA/LAMA combination in COPD: a meta-analysis on the duration of treatment. Eur Respir Rev. 2017;26(143). pii 160043.
  • Montuschi P, Malerba M, Macis G, et al. Triple inhaled therapy for chronic obstructive pulmonary disease. Drug Discov Today. 2016;21(11):1820–1827.
  • Singh D, Papi A, Corradi M, et al. Single inhaler triple therapy versus inhaled corticosteroid plus long-acting beta2-agonist therapy for chronic obstructive pulmonary disease (TRILOGY): a double-blind, parallel group, randomised controlled trial. Lancet. 2016;388(10048):963–973.
  • Vestbo J, Papi A, Corradi M, et al. Single inhaler extrafine triple therapy versus long-acting muscarinic antagonist therapy for chronic obstructive pulmonary disease (TRINITY): a double-blind, parallel group, randomised controlled trial. Lancet. 2017;389(10082):1919–1929.
  • Novartis out-licenses three COPD products in the US [news release]. Available from: https://wwwpharmausnovartiscom/news/media-releases/novartis-out-licenses-three-copd-products-us. Last accessed on October 4th, 2017.
  • Huisman EL, Cockle SM, Ismaila AS, et al. Comparative efficacy of combination bronchodilator therapies in COPD: a network meta-analysis. Int J Chron Obstruct Pulmon Dis. 2015;10:1863–1881.
  • Calzetta L, Rogliani P, Matera MG, et al. A systematic review with meta-analysis of dual bronchodilation with LAMA/LABA for the treatment of stable COPD. Chest. 2016;149(5):1181–1196.
  • Montuschi P, Malerba M, Santini G, et al. Pharmacological treatment of chronic obstructive pulmonary disease: from evidence-based medicine to phenotyping. Drug Discov Today. 2014;19(12):1928–1935.
  • Carpagnano GE, Lacedonia D, Malerba M, et al. Analysis of mitochondrial DNA alteration in new phenotype ACOS. BMC Pulm Med. 2016;16:31.
  • Hizawa N. LAMA/LABA vs ICS/LABA in the treatment of COPD in Japan based on the disease phenotypes. Int J Chron Obstruct Pulmon Dis. 2015;10:1093–1102.
  • Hurst JR, Vestbo J, Anzueto A, et al. Susceptibility to exacerbation in chronic obstructive pulmonary disease. N Engl J Med. 2010;363(12):1128–1138.
  • Pistolesi M, Camiciottoli G, Paoletti M, et al. Identification of a predominant COPD phenotype in clinical practice. Respir Med. 2008;102(3):367–376.

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