Bayesian or frequentist: there is no question when comparing single-inhaler triple therapies via network meta-analysis. Focus on fluticasone furoate/umeclidinium/vilanterol fixed-dose combination in chronic obstructive pulmonary disease

References

• Chaimani A, Caldwell D, Li T, et al. Chapter 11: undertaking network meta-analyses. In: Cochrane handbook for systematic reviews of interventions version 6.3. 2023 [cited 2022 Feb]. Available from: www.training.cochrane.org/handbook Cochrane.
   Google Scholar
• Caldwell DM, Dias S, Welton NJ. Extending treatment networks in health technology assessment: how far should we go? Value Heal. 2015;18(5):673–681. doi: 10.1016/j.jval.2015.03.1792
   PubMed Web of Science ®Google Scholar
• Cooper NJ, Peters J, Lai MCW, et al. How valuable are multiple treatment comparison methods in evidence-based health-care evaluation? Value Heal. 2011;14(2):371–380. doi: 10.1016/j.jval.2010.09.001
   PubMed Web of Science ®Google Scholar
• Moher D, Shamseer L, Clarke M, et al. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. Syst Rev. 2015;4:1. doi: 10.1186/2046-4053-4-1
   PubMed Web of Science ®Google Scholar
• Calzetta L, Ritondo BL, de Marco P, et al. Evaluating triple ICS/LABA/LAMA therapies for COPD patients: a network meta-analysis of ETHOS, KRONOS, IMPACT, and TRILOGY studies. Expert Rev Respir Med. 2021;15(1):143–152. doi: 10.1080/17476348.2020.1816830
   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. Syst Rev Bayes Net Meta-Analysis Res. 2021;100(7):631–643. doi: 10.1159/000515133
   Google Scholar
• Rogliani P, Ritondo BL, Calzetta L. Triple therapy in uncontrolled asthma: a network meta-analysis of phase III studies. Eur Respir J. 2021;58(3):2004233. doi: 10.1183/13993003.04233-2020
   PubMed Web of Science ®Google Scholar
• Kim LHY, Saleh C, Whalen-Browne A, et al. Triple vs dual inhaler therapy and asthma outcomes in moderate to severe asthma: a systematic review and meta-analysis. JAMA. 2021;325(24):2466. doi: 10.1001/jama.2021.7872
   PubMed Web of Science ®Google Scholar
• Ismaila AS, Haeussler K, Czira A, et al. Fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy compared with other therapies for the treatment of COPD: a network meta-analysis. Adv Ther. 2022;39(9):3957–3978. doi:10.1007/S12325-022-02231-0
   PubMed Web of Science ®Google Scholar
• Marshall J, Sharma A, Darken P, et al. Letter to the Editor regarding “fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy compared with other therapies for the treatment of COPD: a network meta-analysis”. Adv Ther. 2023;40(5):2549–2555. doi: 10.1007/S12325-023-02491-4
   PubMed Web of Science ®Google Scholar
• Sadeghirad B, Foroutan F, Zoratti MJ, et al. Theory and practice of bayesian and frequentist frameworks for network meta-analysis. BMJ Evidence-Based Med. 2022;28(3). doi: 10.1136/bmjebm-2022-111928
   PubMedGoogle Scholar
• Harvey R, Charokopou M, Arteaga Duarte C, et al. PNS22 network meta-analysis: a comparison of bayesian and frequentist approaches to synthesis, and evaluation of their suitability for decision-making. Value Heal. 2020;23:S647.
   Web of Science ®Google Scholar
• Comparing bayesian and frequentist approaches for network meta-analysis: an empirical study | colloquium abstracts, (n.d.). [cited 2023 Apr 28]. Available from: https://abstracts.cochrane.org/2017-global-evidence-summit/comparing-bayesian-and-frequentist-approaches-network-meta-analysis
   Google Scholar
• Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials. 1996;17(1):1–12. doi: 10.1016/0197-2456(95)00134-4
   PubMedGoogle Scholar
• Gianinazzi ME, Rueegg CS, Zimmerman K, et al. Intra-rater and inter-rater reliability of a medical record abstraction study on transition of care after childhood cancer. PLoS One. 2015;10(5):e0124290. doi: 10.1371/journal.pone.0124290
   PubMed Web of Science ®Google Scholar
• Owen RK, Bradbury N, Xin Y, et al. MetaInsight: an interactive web-based tool for analyzing, interrogating, and visualizing network meta-analyses using R-shiny and netmeta. Res Synth Methods. 2019;10(4):569–581.
   PubMed Web of Science ®Google Scholar
• Spiegelhalter DJ, Abrams KR, Myles JP. Bayesian approaches to clinical trials and health-care evaluation. Hoboken, New Jersey, US: John Wiley & Sons; 2004.
   Google Scholar
• Lu G, Ades AE. Assessing evidence inconsistency in mixed treatment comparisons. J Am Stat Assoc. 2006;101(474):447–459. doi: 10.1198/016214505000001302
   Web of Science ®Google Scholar
• van Valkenhoef G, Lu G, de Brock B, et al. Automating network meta-analysis. Res Synth Methods. 2012;3(4):285–299. doi: 10.1002/jrsm.1054
   PubMed Web of Science ®Google Scholar
• van Valkenhoef G, Dias S, Ades AE, et al. Automated generation of node‐splitting models for assessment of inconsistency in network meta‐analysis. Res Synth Methods. 2016;7(1):80–93. doi: 10.1002/jrsm.1167
   PubMed Web of Science ®Google Scholar
• Dias S, Welton NJ, Sutton AJ, et al. Evidence synthesis for decision making 4: inconsistency in networks of evidence based on randomized controlled trials. Med Decis Mak. 2013;33(5):641–656. doi: 10.1177/0272989X12455847
   PubMed Web of Science ®Google Scholar
• Stogiannis D, Siannis F, Androulakis E. Heterogeneity in meta-analysis: a comprehensive overview. Int J Biostat. 2023. doi: 10.1515/ijb-2022-0070
   PubMedGoogle Scholar
• 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. doi: 10.1016/j.chest.2016.02.646
   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;383:35–48. doi: 10.1056/nejmoa1916046
   PubMed Web of Science ®Google Scholar
• Rabe KF, Martinez FJ, Singh D, et al. Improvements in lung function with budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler versus dual therapies in patients with COPD: a sub-study of the ETHOS trial, ther. Adv Respir Dis. 2021;15:175346662110343. doi: 10.1177/17534666211034329
   Web of Science ®Google Scholar
• NCT02465567, Study to assess the efficacy and safety of PT010 relative to PT003 and PT009 in subjects with moderate to very severe COPD (ethos), (2015).
   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
• NCT02345161, A comparison study between the fixed dose triple combination of fluticasone furoate/umeclidinium/vilanterol trifenatate (FF/UMEC/VI) with budesonide/formoterol in subjects with chronic obstructive pulmonary disease (COPD), (2015).
   Google Scholar
• GlaxoSmithKline (116853), A comparison study between the fixed dose triple combination of fluticasone furoate/umeclidinium/vilanterol trifenatate (FF/UMEC/VI) with budesonide/formoterol in subjects with chronic obstructive pulmonary disease (COPD), 2015.
   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.
   PubMed Web of Science ®Google Scholar
• NCT02164513, A study comparing the efficacy, safety and tolerability of fixed dose combination (FDC) of FF/UMEC/VI with the FDC of FF/VI and UMEC/VI; administered once-daily via a dry powder inhaler (DPI) in subjects with chronic obstructive pulmonary disease (COPD), (2014).
   Google Scholar
• GlaxoSmithKline (116855), A study comparing the efficacy, safety and tolerability of fixed dose combination (FDC) of FF/UMEC/VI with the FDC of FF/VI and UMEC/VI; administered once-daily via a dry powder inhaler (DPI) in subjects with chronic obstructive pulmonary disease, 2014.
   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;6:747–758. doi: 10.1016/S2213-2600(18)30327-8
   Web of Science ®Google Scholar
• NCT02497001, A randomized, double-blind, parallel-group, 24-week, chronic-dosing, multi-center study to assess the efficacy and safety of PT010, PT003, and PT009 compared with symbicort® turbuhaler® (Kronos) (KRONOS), (2015).
   Google Scholar
• Bremner PR, Birk R, Brealey N, et al. Single-inhaler fluticasone furoate/umeclidinium/vilanterol versus fluticasone furoate/vilanterol plus umeclidinium using two inhalers for chronic obstructive pulmonary disease: a randomized non-inferiority study, Respir. Res. 2018;19. doi: 10.1186/S12931-018-0724-0
   Google Scholar
• NCT02729051. Comparative study of fluticasone furoate(FF)/umeclidinium bromide (umec)/vilanterol (VI) closed therapy versus FF/VI plus UMEC Open therapy in subjects with chronic obstructive pulmonary disease (COPD). 2015. https://clinicaltrials.gov/study/NCT02729051
   Google Scholar
• GlaxoSmithKline (200812). Comparative study of fluticasone furoate(FF)/umeclidinium bromide (umec)/vilanterol (VI) closed therapy versus FF/VI plus UMEC open therapy in subjects with chronic obstructive pulmonary disease (COPD). 2016. https://www.gsk-studyregister.com/en/trial-details/?id=200812
   Google Scholar
• Röver C, Bender R, Dias S, et al. On weakly informative prior distributions for the heterogeneity parameter in Bayesian random-effects meta-analysis. Res Synth Methods. 2021;12(4):448–474. doi: 10.1002/JRSM.1475
   PubMed Web of Science ®Google Scholar
• Röver C, Sturtz S, Lilienthal J, et al. Summarizing empirical information on between-study heterogeneity for Bayesian random-effects meta-analysis. Stat Med. 2023;42(14):2439–2454. doi: 10.1002/sim.9731
   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
• Eriksson G, Calverley PM, Jenkins CR, et al. The effect of COPD severity and study duration on exacerbation outcome in randomized controlled trials. Int J COPD. 2017;12. doi: 10.2147/COPD.S130713
   Google Scholar
• 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):160043. doi: 10.1183/16000617.0043-2016
   PubMed Web of Science ®Google Scholar
• Ye F, Wang C, O’Connor AM. When we shouldn’t borrow information from an existing network of trials for planning a new trial. Front Pharmacol. 2023;14. doi: 10.3389/fphar.2023.1157708
   Web of Science ®Google Scholar
• GOLD, 2024 GOLD report - global initiative for chronic obstructive lung disease - GOLD. Available from: https://goldcopd.org/2024-gold-report/, (2024).
   Google Scholar
• Hurst JR, Skolnik N, Hansen GJ, et al. Understanding the impact of chronic obstructive pulmonary disease exacerbations on patient health and quality of life. Eur J Intern Med. 2020;73:1–6. doi: 10.1016/j.ejim.2019.12.014
   PubMed Web of Science ®Google Scholar
• van Haarst A, McGarvey L, Paglialunga S. Review of drug development guidance to treat chronic obstructive pulmonary disease: US and EU Perspectives. Clin Pharmacol Ther. 2019;106(6):1222–1235. doi: 10.1002/cpt.1540
   PubMed Web of Science ®Google Scholar
• Mapel DW, McMillan GP, Frost FJ, et al. Predicting the costs of managing patients with chronic obstructive pulmonary disease. Respir med. 2005;99(10):1325–1333. doi: 10.1016/j.rmed.2005.03.001
   PubMed Web of Science ®Google Scholar
• Ke J, Marvel X, Yu TC, et al. Impact of lung function on exacerbations, health care utilization, and costs among patients with COPD. Int J COPD. 2016;11:1689–1703. doi: 10.2147/COPD.S108967
   Google Scholar
• 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. doi: 10.1016/S0140-6736(17)30188-5
   PubMed Web of Science ®Google Scholar
• Salvi S, Balki A, Krishnamurthy S, et al. Efficacy and safety of single-inhaler triple therapy of glycopyrronium, formoterol and fluticasone in patients with COPD: a double-blind, randomised controlled trial. ERJ Open Res. 2021;7(3):00255–2021. doi: 10.1183/23120541.00255-2021
   PubMedGoogle Scholar
• Guyatt G, Murad MH, Heels-Ansdell D, et al., Problems with Bayesian random effects in network meta-analysis | colloquium abstracts, (n.d.) [cited 2023 Jul 4]. Available from: https://abstracts.cochrane.org/2015-vienna/problems-bayesian-random-effects-network-meta-analysis
   Google Scholar
• Jansen JP, Trikalinos T, Cappelleri JC, et al. Indirect treatment comparison/network meta-analysis study questionnaire to assess relevance and credibility to inform health care decision making: an ISPOR-AMCP-NPC good practice task force report. Value Health. 2014;17:157–173. doi: 10.1016/J.JVAL.2014.01.004
   PubMed Web of Science ®Google Scholar
• Deeks J, Higgins JP, Altman DG, Chapter 10: Analysing Data And Undertaking Meta-Analyses. Cochrane Training, (n.d.) [cited 2023 Jul 4]. https://training.cochrane.org/handbook/current/chapter-10
   Google Scholar
• Tonin FS, Rotta I, Mendes AM, et al. Network meta-analysis: a technique to gather evidence from direct and indirect comparisons. Pharm Pract (Granada). 2017;15(1):943–943. doi: 10.18549/PHARMPRACT.2017.01.943
   PubMed Web of Science ®Google Scholar
• Dias S, Caldwell DM. Network meta-analysis explained. Arch Dis Child Fetal Neonatal Ed. 2019;104(1):F8. doi: 10.1136/ARCHDISCHILD-2018-315224
   PubMed Web of Science ®Google Scholar
• Higgins JPT, Jackson D, Barrett JK, et al. Consistency and inconsistency in network meta-analysis: concepts and models for multi-arm studies. Res Synth Methods. 2012;3(2):98–110. doi: 10.1002/JRSM.1044
   PubMed Web of Science ®Google Scholar
• Hoaglin DC, Hawkins N, Jansen JP, et al. Conducting indirect-treatment-comparison and network-meta-analysis studies: report of the ISPOR task force on indirect treatment comparisons good research practices: part 2. Value Health. 2011;14:429–437. doi: 10.1016/J.JVAL.2011.01.011
   PubMed Web of Science ®Google Scholar
• Hackenberger BK. Bayesian meta-analysis now – let’s do it. Med J. 2020;61(6):564. doi: 10.3325/CMJ.2020.61.564
   Google Scholar
• Efthimiou O, White IR. The dark side of the force: multiplicity issues in network meta-analysis and how to address them. Res Synth Methods. 2020;11(1):105–122.
   PubMed Web of Science ®Google Scholar
• Seide SE, Jensen K, Kieser M. A comparison of Bayesian and frequentist methods in random-effects network meta-analysis of binary data. Res Synth Methods. 2020;11(3):363–378.
   PubMed Web of Science ®Google Scholar