Quantitative analysis of efficacy and safety of LABA/LAMA fixed-dose combinations in the treatment of stable COPD

1. Lopez, AD, Shibuya, K, Rao, C, et al Chronic obstructive pulmonary disease: current burden and future projections. Eur Respir J 2006; 27(2): 397–412.
Google Scholar | Crossref | Medline | ISI2. Chokhani, R, Muttalif, AR, Gunasekera, K, et al. Understanding practice patterns of COPD: a survey of physicians in Nepal, Sri Lanka and Malaysia. Pulm Ther 2021; 7: 251–265.
Google Scholar | Crossref3. Celli, BR . Pharmacological therapy of COPD: reasons for optimism. Chest 2018; 154(6): 1404–1415.
Google Scholar | Crossref | Medline4. Global Initiative for Chronic Obstructive Lung Disease . Global strategy for the diagnosis, management and prevention of chronic obstructive pulmonary disease 2021 report, 2020, https://goldcopd.org/wp-content/uploads/2020/11/GOLD-REPORT-2021-v1.1-25Nov20_WMV.pdf (accessed 17 November 2020).
Google Scholar5. 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.
Google Scholar | Crossref | Medline6. Calverley, PMA, Anzueto, AR, Carter, K, et al Tiotropium and olodaterol in the prevention of chronic obstructive pulmonary disease exacerbations (DYNAGITO): a double-blind, randomised, parallel-group, active-controlled trial. Lancet Respir Med 2018; 6(5): 337–344.
Google Scholar | Crossref | Medline7. Calzetta, L, Di Marco, F, Blasi, F, et al Impact of ICS/LABA and LABA/LAMA FDCs on functional and clinical outcomes in COPD: a network meta-analysis. Pulm Pharmacol Ther 2019; 59: 101855.
Google Scholar | Crossref | Medline8. 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.
Google Scholar | Crossref | Medline | ISI9. 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: 969–979.
Google Scholar | Crossref | Medline | ISI10. Lipworth, BJ, Collier, DJ, Gon, Y, et al Improved lung function and patient-reported outcomes with co-suspension delivery technology glycopyrrolate/formoterol fumarate metered dose inhaler in COPD: a randomized Phase III study conducted in Asia, Europe, and the USA. Int J Chron Obstruct Pulmon Dis 2018; 13: 2969–2984.
Google Scholar | Crossref | Medline11. 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.
Google Scholar | Crossref | Medline | ISI12. Zheng, JP, Zhong, NS, Newlands, AH, et al Efficacy and safety of once-daily inhaled umeclidinium/vilanterol in Asian patients with COPD: results from a randomized, placebo-controlled study. Int J Chron Obstruct Pulmon Dis 2015; 10: 1753–1767.
Google Scholar | Crossref | Medline13. Mandema, JW, Gibbs, M, Boyd, RA, et al Model-based meta-analysis for comparative efficacy and safety: application in drug development and beyond. Clin Pharmacol Ther 2011; 90(6): 766–769.
Google Scholar | Crossref | Medline14. Mould, DR . Model-based meta-analysis: an important tool for making quantitative decisions during drug development. Clin Pharmacol Ther 2012; 92(3): 283–286.
Google Scholar | Crossref | Medline15. Moher, D, Liberati, A, Tetzlaff, J, et al Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ 2009; 339: b2535.
Google Scholar | Crossref | Medline16. Higgins, JPT, Green, S. Cochrane Handbook for Systematic Reviews of Interventions. Version 5.1.0, 2011, http://training.cochrane.org/handbook (accessed 20 November 2020).
Google Scholar17. Price, D, Yawn, B, Brusselle, G, et al Risk-to-benefit ratio of inhaled corticosteroids in patients with COPD. Prim Care Respir J 2013; 22(1): 92–100.
Google Scholar | Crossref | Medline18. Dong, Z, Xu, L, Liu, H, et al Comparative efficacy of five long-term weight loss drugs: quantitative information for medication guidelines. Obes Rev 2017; 18: 1377–1385.
Google Scholar | Crossref | Medline19. Wählby, U, Jonsson, EN, Karlsson, MO. Assessment of actual significance levels for covariate effects in NONMEM. J Pharmacokinet Pharmacodyn 2001; 28(3): 231–252.
Google Scholar | Crossref | Medline20. 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.
Google Scholar | Crossref | Medline21. Donohue, JF, Soong, W, Wu, X, et al Long-term safety of aclidinium bromide/formoterol fumarate fixed-dose combination: results of a randomized 1-year trial in patients with COPD. Respir Med 2016; 116: 41–48.
Google Scholar | Crossref | Medline22. Kalberg, C, O’Dell, D, Galkin, D, et al Dual bronchodilator therapy with umeclidinium/vilanterol versus tiotropium plus indacaterol in chronic obstructive pulmonary disease: a randomized controlled trial. Drugs R D 2016; 16(2): 217–227.
Google Scholar | Crossref | Medline23. Maltais, F, Ferguson, GT, Feldman, GJ, et al A randomized, double-blind, double-dummy study of glycopyrrolate/formoterol fumarate metered dose inhaler relative to umeclidinium/vilanterol dry powder inhaler in COPD. Adv Ther 2019; 36(9): 2434–2449.
Google Scholar | Crossref | Medline24. 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: 340–357.
Google Scholar | Crossref | Medline25. 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.
Google Scholar | Crossref | Medline26. ZuWallack, R, Allen, L, Hernandez, G, et al Efficacy and safety of combining olodaterol Respimat(®) and tiotropium HandiHaler(®) in patients with COPD: results of two randomized, double-blind, active-controlled studies. Int J Chron Obstruct Pulmon Dis 2014; 9: 1133–1144.
Google Scholar | Crossref | Medline27. D’Urzo, A, Rennard, S, Kerwin, E, 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.
Google Scholar | Crossref | Medline | ISI28. Decramer, M, Anzueto, A, Kerwin, E, et al Efficacy and safety of umeclidinium plus vilanterol versus tiotropium, vilanterol, or umeclidinium monotherapies over 24 weeks in patients with chronic obstructive pulmonary disease: results from two multicentre, blinded, randomised controlled trials. Lancet Respir Med 2014; 2(6): 472–486.
Google Scholar | Crossref | Medline29. Donohue, JF, Maleki-Yazdi, MR, Kilbride, S, et al Efficacy and safety of once-daily umeclidinium/vilanterol 62.5/25 mcg in COPD. Respir Med 2013; 107(10): 1538–1546.
Google Scholar | Crossref | Medline | ISI30. Maleki-Yazdi, MR, Kaelin, T, Richard, N, et al Efficacy and safety of umeclidinium/vilanterol 62.5/25 mcg and tiotropium 18 mcg in chronic obstructive pulmonary disease: results of a 24-week, randomized, controlled trial. Respir Med 2014; 108(12): 1752–1760.
Google Scholar | Crossref | Medline31. Celli, B, Crater, G, Kilbride, S, et al Once-daily umeclidinium/vilanterol 125/25 mcg in COPD: a randomized, controlled study. Chest 2014; 145(5): 981–991.
Google Scholar | Crossref | Medline32. Chen, R, Zhong, N, Wang, HY, et al Efficacy and safety of glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI) formulated using co-suspension delivery technology in Chinese patients with COPD. Int J Chron Obstruct Pulmon Dis 2020; 15: 43–56.
Google Scholar | Crossref | Medline33. Siler, TM, Donald, AC, O’Dell, D, et al A randomized, parallel-group study to evaluate the efficacy of umeclidinium/vilanterol 62.5/25 µg on health-related quality of life in patients with COPD. Int J Chron Obstruct Pulmon Dis 2016; 11: 971–979.
Google Scholar | Crossref | Medline34. Buhl, R, Gessner, C, Schuermann, W, et al Efficacy and safety of once-daily QVA149 compared with the free combination of once-daily tiotropium plus twice-daily formoterol in patients with moderate-to-severe COPD (QUANTIFY): a randomised, non-inferiority study. Thorax 2015; 70(4): 311–319.
Google Scholar | Crossref | Medline35. Ferguson, GT, Rabe, KF, Martinez, FJ, et al Triple therapy with budesonide/glycopyrrolate/formoterol fumarate with co-suspension delivery technology versus dual therapies in chronic obstructive pulmonary disease (KRONOS): a double-blind, parallel-group, multicentre, phase 3 randomised controlled trial. Lancet Respir Med 2018; 6(10): 747–758.
Google Scholar | Medline36. Wedzicha, JA, Zhong, N, Ichinose, M, et al Indacaterol/glycopyrronium versus salmeterol/fluticasone in Asian patients with COPD at a high risk of exacerbations: results from the FLAME study. Int J Chron Obstruct Pulmon Dis 2017; 12: 339–349.
Google Scholar | Crossref | Medline37. Donohue, JF, Niewoehner, D, Brooks, J, et al Safety and tolerability of once-daily umeclidinium/vilanterol 125/25 mcg and umeclidinium 125 mcg in patients with chronic obstructive pulmonary disease: results from a 52-week, randomized, double-blind, placebo-controlled study. Respir Res 2014; 15: 78.
Google Scholar | Crossref | Medline | ISI38. European Medicines Agency . Guideline on clinical investigation of medicinal products in the treatment of chronic obstructive pulmonary disease (COPD), 2012, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/08/WC500130880.pdf (accessed 7 March 2021).
Google Scholar39. Schlueter, M, Gonzalez-Rojas, N, Baldwin, M, et al Comparative efficacy of fixed-dose combinations of long-acting muscarinic antagonists and long-acting β2-agonists: a systematic review and network meta-analysis. Ther Adv Respir Dis 2016; 10(2): 89–104.
Google Scholar | SAGE Journals | ISI40. Kim, SJ, Lee, J, Park, YS, et al Age-related annual decline of lung function in patients with COPD. Int J Chron Obstruct Pulmon Dis 2016; 11: 51–60.
Google Scholar | Medline41. Gladysheva, ES, Malhotra, A, Owens, RL. Influencing the decline of lung function in COPD: use of pharmacotherapy. Int J Chron Obstruct Pulmon Dis 2010; 5: 153–164.
Google Scholar | Medline42. Vestbo, J, Edwards, LD, Scanlon, PD, et al Changes in forced expiratory volume in 1 second over time in COPD. N Engl J Med 2011; 365: 1184–1192.
Google Scholar | Crossref | Medline | ISI

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