Mortality risk reduction with budesonide/glycopyrrolate/formoterol fumarate versus fluticasone furoate/umeclidinium/vilanterol in COPD: a matching-adjusted indirect comparison based on ETHOS and IMPACT

References

• Global Initiative for Chronic Obstructive Lung Disease. 2023 GOLD Report. Global strategy for prevention, diagnosis and management of COPD [Internet]. 2023 [cited November 20, 2022]. Available from: https://goldcopd.org/2023-gold-report-2/.
   Google Scholar
• Safiri S, Carson-Chahhoud K, Noori M, et al. Burden of chronic obstructive pulmonary disease and its attributable risk factors in 204 countries and territories, 1990–2019: results from the global burden of disease study 2019. BMJ. 2022;378:e069679. doi: 10.1136/bmj-2021-069679.
   PubMed Web of Science ®Google Scholar
• Roth GA, Abate D, Abate KH, et al. Global, regional, and national age-sex-specific mortality for 282 causes of death in 195 countries and territories, 1980–2017: a systematic analysis for the global burden of disease study 2017. Lancet. 2018;392(10159):1736–1788. doi: 10.1016/S0140-6736(18)32203-7.
   PubMed Web of Science ®Google Scholar
• Rothnie KJ, Connell O, Müllerová H, et al. Myocardial infarction and ischemic stroke after exacerbations of chronic obstructive pulmonary disease. Ann Am Thorac Soc. 2018;15(8):935–946. doi: 10.1513/AnnalsATS.201710-815OC.
   PubMed Web of Science ®Google Scholar
• 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. doi: 10.1056/NEJMoa0909883.
   PubMed Web of Science ®Google Scholar
• Feary JR, Rodrigues LC, Smith CJ, et al. Prevalence of major comorbidities in subjects with COPD and incidence of myocardial infarction and stroke: a comprehensive analysis using data from primary care. Thorax. 2010;65(11):956–962. doi: 10.1136/thx.2009.128082.
   PubMed Web of Science ®Google Scholar
• Berry CE, Wise RA. Mortality in COPD: causes, risk factors, and prevention. COPD. 2010;7(5):375–382. doi: 10.3109/15412555.2010.510160.
   PubMedGoogle Scholar
• McGarvey LP, John M, Anderson JA, et al. Ascertainment of cause-specific mortality in COPD: operations of the TORCH clinical endpoint committee. Thorax. 2007;62(5):411–415. doi: 10.1136/thx.2006.072348.
   PubMed Web of Science ®Google Scholar
• Kunisaki KM, Dransfield MT, Anderson JA, et al. Exacerbations of chronic obstructive pulmonary disease and cardiac events. A post hoc cohort analysis from the SUMMIT randomized clinical trial. Am J Respir Crit Care Med. 2018;198(1):51–57. doi: 10.1164/rccm.201711-2239OC.
   PubMed Web of Science ®Google Scholar
• Suissa S, Dell’Aniello S, Ernst P. Long-term natural history of chronic obstructive pulmonary disease: severe exacerbations and mortality. Thorax. 2012;67(11):957–963. doi: 10.1136/thoraxjnl-2011-201518.
   PubMed Web of Science ®Google Scholar
• Whittaker H, Rubino A, Müllerová H, et al. Frequency and severity of exacerbations of COPD associated with future risk of exacerbations and mortality: a UK routine health care data study. Int J Chron Obstruct Pulmon Dis. 2022;17:427–437. doi: 10.2147/COPD.S346591.
   PubMed Web of Science ®Google Scholar
• Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006;3(11):e442. doi: 10.1371/journal.pmed.0030442.
   PubMed Web of Science ®Google Scholar
• GBD 2016 Causes of Death Collaborators. Global, regional, and national age-sex specific mortality for 264 causes of death, 1980–2016: a systematic analysis for the global burden of disease study 2016. Lancet. 2017;390(10100):1151–1210. doi: 10.1016/S0140-6736(17)32152-9.
   PubMed Web of Science ®Google Scholar
• Rabe KF, Martinez FJ, Ferguson GT, et al. Triple inhaled therapy at two glucocorticoid doses in moderate-to-very-severe COPD. N Engl J Med. 2020;383(1):35–48. doi: 10.1056/NEJMoa1916046.
   PubMed Web of Science ®Google Scholar
• 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. doi: 10.1016/S2213-2600(18)30327-8.
   PubMed Web of Science ®Google Scholar
• Lipson DA, Barnhart F, Brealey N, et al. Once-daily single-inhaler triple versus dual therapy in patients with COPD. N Engl J Med. 2018;378(18):1671–1680. doi: 10.1056/NEJMoa1713901.
   PubMed Web of Science ®Google Scholar
• Lipson DA, Barnacle H, Birk R, et al. FULFIL trial: once-daily triple therapy for patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2017;196(4):438–446. doi: 10.1164/rccm.201703-0449OC.
   PubMed Web of Science ®Google Scholar
• Papi A, Vestbo J, Fabbri L, et al. Extrafine inhaled triple therapy versus dual bronchodilator therapy in chronic obstructive pulmonary disease (TRIBUTE): a double-blind, parallel group, randomised controlled trial. Lancet. 2018;391(10125):1076–1084. doi: 10.1016/S0140-6736(18)30206-X.
   PubMed Web of Science ®Google Scholar
• Singh D, Papi A, Corradi M, et al. Single inhaler triple therapy versus inhaled corticosteroid plus long-acting β2-agonist therapy for chronic obstructive pulmonary disease (TRILOGY): a double-blind, parallel group, randomised controlled trial. Lancet. 2016;388(10048):963–973. doi: 10.1016/S0140-6736(16)31354-X.
   PubMed Web of Science ®Google Scholar
• AstraZeneca Pharmaceuticals LP. Breztri Aerosphere™ Prescribing Information [Internet]. 2020 [cited June 13, 2023]. Available from: https://www.azpicentral.com/breztri/breztri.pdf.
   Google Scholar
• GlaxoSmithKline. Anoro® Ellipta® Prescribing Information [Internet]. 2019 [cited December 15, 2022]. Available from: https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Anoro_Ellipta/pdf/ANORO-ELLIPTA-PI-MG-IFU.PDF.
   Google Scholar
• Chiesi Limited. Trimbow 87 µg/5 µg/9 µg pressurised inhalation solution SmPC [Internet]. 2022 [cited October 31, 2022]. Available from: https://www.medicines.org.uk/emc/product/761/smpc.
   Google Scholar
• Martinez FJ, Rabe KF, Ferguson GT, et al. Reduced all-cause mortality in the ETHOS trial of budesonide/glycopyrrolate/formoterol for chronic obstructive pulmonary disease. A randomized, double-blind, multicenter, parallel-group study. Am J Respir Crit Care Med. 2021;203(5):553–564. doi: 10.1164/rccm.202006-2618OC.
   PubMed Web of Science ®Google Scholar
• Lipson DA, Crim C, Criner GJ, et al. Reduction in all-cause mortality with fluticasone furoate/umeclidinium/vilanterol in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2020;201(12):1508–1516. doi: 10.1164/rccm.201911-2207OC.
   PubMed Web of Science ®Google Scholar
• Vestbo J, Fabbri L, Papi A, et al. Inhaled corticosteroid containing combinations and mortality in COPD. Eur Respir J. 2018;52(6):1801230. doi: 10.1183/13993003.01230-2018.
   PubMed Web of Science ®Google Scholar
• Usmani OS, Roche N, Jenkins M, et al. Consistent pulmonary drug delivery with whole lung deposition using the aerosphere inhaler: a review of the evidence. Int J Chron Obstruct Pulmon Dis. 2021;16:113–124. doi: 10.2147/COPD.S274846.
   PubMed Web of Science ®Google Scholar
• Lee HW, Kim HJ, Jang EJ, et al. Comparisons of efficacy and safety between triple (inhaled corticosteroid/long-acting muscarinic antagonist/long-acting beta-agonist) therapies in chronic obstructive pulmonary disease: systematic review and bayesian network meta-analysis. Respiration. 2021;100(7):631–643. doi: 10.1159/000515133.
   PubMed Web of Science ®Google Scholar
• Rogliani P, Ora J, Cavalli F, et al. Comparing the efficacy and safety profile of triple fixed-dose combinations in COPD: a meta-analysis and IBiS score. J Clin Med. 2022;11(15):4491. doi: 10.3390/jcm11154491.
   PubMed Web of Science ®Google Scholar
• Phillippo DM, Ades AE, Dias S, et al. Methods for population-adjusted indirect comparisons in health technology appraisal. Med Decis Making. 2018;38(2):200–211. doi: 10.1177/0272989X17725740.
   PubMed Web of Science ®Google Scholar
• Phillippo D, Ades T, Dias S, et al. NICE DSU technical support document 18: methods for population-adjusted indirect comparisons in submissions to NICE. Commissioned report. Decision Support Unit, ScHARR, University of Sheffield: NICE Decision Support Unit; 2016.
   Google Scholar
• Signorovitch JE, Sikirica V, Erder MH, et al. Matching-adjusted indirect comparisons: a new tool for timely comparative effectiveness research. Value Health. 2012;15(6):940–947. doi: 10.1016/j.jval.2012.05.004.
   PubMed Web of Science ®Google Scholar
• Signorovitch JE, Wu EQ, Yu AP, et al. Comparative effectiveness without head-to-head trials: a method for matching-adjusted indirect comparisons applied to psoriasis treatment with adalimumab or etanercept. Pharmacoeconomics. 2010;28(10):935–945. doi: 10.2165/11538370-000000000-00000.
   PubMed Web of Science ®Google Scholar
• Zhang Z, Kim HJ, Lonjon G, et al. Balance diagnostics after propensity score matching. Ann Transl Med. 2019;7(1):16. doi: 10.21037/atm.2018.12.10.
   PubMed Web of Science ®Google Scholar
• Rohatgi A. WebPlotDigitizer. v4.6. 2022. Available from: https://automeris.io/WebPlotDigitizer/.
   Google Scholar
• Guyot P, Ades AE, Ouwens MJNM, et al. Enhanced secondary analysis of survival data: reconstructing the data from published Kaplan-Meier survival curves. BMC Medical Res Methodol. 2012;12(1):1–13.
   PubMed Web of Science ®Google Scholar
• André S, Conde B, Fragoso E, et al. COPD and cardiovascular disease. Pulmonology. 2019;25(3):168–176. doi: 10.1016/j.pulmoe.2018.09.006.
   PubMed Web of Science ®Google Scholar
• Böhm M, Schumacher H, Teo KK, et al. Cardiovascular outcomes in patients at high cardiovascular risk with previous myocardial infarction or stroke. J Hypertens. 2021;39(8):1602–1610. doi: 10.1097/HJH.0000000000002822.
   PubMed Web of Science ®Google Scholar
• Chen H, Deng ZX, Sun J, et al. Association of inhaled corticosteroids with all-cause mortality risk in patients with COPD: a meta-analysis of 60 randomized controlled trials. Chest. 2023;163(1):100–114. doi: 10.1016/j.chest.2022.07.015.
   PubMed Web of Science ®Google Scholar
• Suissa S, Dell’Aniello S, Ernst P. Fluticasone-based versus budesonide-based triple therapies in COPD: real-world comparative effectiveness and safety. COPD. 2022;19(1):109–117. doi: 10.1080/15412555.2022.2035705.
   PubMedGoogle Scholar
• Chen H, Sun J, Huang Q, et al. Inhaled corticosteroids and the pneumonia risk in patients with chronic obstructive pulmonary disease: a meta-analysis of randomized controlled trials. Front Pharmacol. 2021;12:691621. doi: 10.3389/fphar.2021.691621.
   PubMed Web of Science ®Google Scholar
• 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. doi: 10.1007/s12325-019-01015-3.
   PubMed Web of Science ®Google Scholar
• Gong Y, Lv Y, Liu H, et al. Quantitative analysis of efficacy and safety of LABA/LAMA fixed-dose combinations in the treatment of stable COPD. Ther Adv Respir Dis. 2022;16. doi: 10.1177/17534666211066068.
   PubMed Web of Science ®Google Scholar
• Lee HW, Park J, Jang EJ, et al. Comparisons of exacerbations and mortality among LAMA/LABA combinations in stable chronic obstructive pulmonary disease: systematic review and bayesian network meta-analysis. Respir Res. 2020;21(1):310. doi: 10.1186/s12931-020-01540-8.
   PubMed Web of Science ®Google Scholar
• Larsson K, Janson C, Lisspers K, et al. 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(6):584–594. doi: 10.1111/joim.12067.
   PubMed Web of Science ®Google Scholar
• Brattsand R, Selroos O. May a different kinetic mode explain the high efficacy/safety profile of inhaled budesonide? Pulm Pharmacol Ther. 2022;77:102167. doi: 10.1016/j.pupt.2022.102167.
   PubMed Web of Science ®Google Scholar
• Marshall J, Li G, Backer JD, et al. Small airways deposition of two fixed-dose triple therapy combinations assessed with functional respiratory imaging (FRI). American Throracic Society International Conference 2023 (poster presentation P406). doi: 10.1164/ajrccm-conference.2023.207.1_MeetingAbstracts.A1556.
   Google Scholar
• Doty A, Schroeder J, Vang K, et al. Drug delivery from an innovative LAMA/LABA co-suspension delivery technology fixed-dose combination MDI: evidence of consistency, robustness, and reliability. AAPS PharmSciTech. 2018;19(2):837–844. doi: 10.1208/s12249-017-0891-1.
   PubMed Web of Science ®Google Scholar
• Taylor G, Warren S, Dwivedi S, et al. Gamma scintigraphic pulmonary deposition study of glycopyrronium/formoterol metered dose inhaler formulated using co-suspension delivery technology. Eur J Pharm Sci. 2018;111:450–457. doi: 10.1016/j.ejps.2017.10.026.
   PubMed Web of Science ®Google Scholar
• Rabe KF, Martinez FJ, Ferguson GT, et al. A phase III study of triple therapy with budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler 320/18/9.6 μg and 160/18/9.6 μg using co-suspension delivery technology in moderate-to-very severe COPD: the ETHOS study protocol. Respir Med. 2019;158:59–66. doi: 10.1016/j.rmed.2019.08.010.
   PubMed Web of Science ®Google Scholar
• Mannino DM, Doherty DE, Sonia Buist A. Global initiative on obstructive lung disease (GOLD) classification of lung disease and mortality: findings from the atherosclerosis risk in communities (ARIC) study. Respir Med. 2006;100(1):115–122. doi: 10.1016/j.rmed.2005.03.035.
   PubMed Web of Science ®Google Scholar
• DeTora LM, Toroser D, Sykes A, et al. Good publication practice (GPP) guidelines for company-sponsored biomedical research: 2022 update. Ann Intern Med. 2022;175(9):1298–1304. doi: 10.7326/M22-1460.
   PubMed Web of Science ®Google Scholar