Single-Inhaler Triple versus Dual Bronchodilator Therapy in COPD: Real-World Comparative Effectiveness and Safety

References

• Vogelmeier CF, Criner GJ, Martinez FJ., et al. Global strategy for the diagnosis, management, and prevention of chronic obstructive lung disease 2017 Report: GOLD Executive Summary. Eur Respir J. 2017;49(3):548. doi:10.1183/13993003.00214-2017
   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
• 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
• 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
• 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
• Suissa S, Drazen JM. Making sense of triple inhaled therapy for COPD. N Engl J Med. 2018;378(18):1723–1724. doi:10.1056/NEJMe1716802
   PubMed Web of Science ®Google Scholar
• Suissa S, Ariel A. Triple therapy trials in COPD: a precision medicine opportunity. Eur Respir J. 2018;52(6):1801848. doi:10.1183/13993003.01848-2018
   PubMed Web of Science ®Google Scholar
• Wedzicha JA, Banerji D, Kostikas K. Single-inhaler triple versus dual therapy in patients with COPD. N Eng J Med. 2018;379(6):590–593.
   PubMed Web of Science ®Google Scholar
• Suissa S. Perplexing mortality data from triple therapy trials in COPD. Lancet Respir Med. 2021;9(7):684–685. doi:10.1016/S2213-2600(21)00238-1
   PubMed Web of Science ®Google Scholar
• Han MK, Dransfield MT, Dransfield MT, et al. The effect of ICS withdrawal and baseline inhaled treatment on exacerbations in the IMPACT study. Am J Respir Crit Care Med. 2020;202(9):1237–1243. doi:10.1164/rccm.201912-2478OC
   PubMed Web of Science ®Google Scholar
• Suissa S. Triple Therapy in COPD: time for adaptive selection trials. COPD. 2021;18(6):597–601. doi:10.1080/15412555.2021.1982886
   PubMedGoogle Scholar
• Wolf A, Dedman D, Campbell J, et al. Data resource profile: Clinical Practice Research Datalink (CPRD) Aurum. Int J Epidemiol. 2019;48(6):1740–1740g. doi:10.1093/ije/dyz034
   PubMed Web of Science ®Google Scholar
• Herrett E, Thomas SL, Schoonen WM, Smeeth L, Hall AJ. Validation and validity of diagnoses in the general practice research database: a systematic review. Br J Clin Pharmacol. 2010;69(1):4–14. doi:10.1111/j.1365-2125.2009.03537.x
   PubMed Web of Science ®Google Scholar
• Herrett E, Gallagher AM, Bhaskaran K, et al. Data Resource Profile: Clinical Practice Research Datalink (CPRD). Int J Epidemiol. 2015;44(3):827–836. doi:10.1093/ije/dyv098
   PubMed Web of Science ®Google Scholar
• Quint JK, Mullerova H, DiSantostefano RL, et al. Validation of chronic obstructive pulmonary disease recording in the Clinical Practice Research Datalink (CPRD-GOLD). BMJ Open. 2014;4(7):e005540. doi:10.1136/bmjopen-2014-005540
   PubMed Web of Science ®Google Scholar
• Rothnie KJ, Müllerová H, Thomas SL, et al. Recording of hospitalizations for acute exacerbations of COPD in UK electronic health care records. Clin Epidemiol. 2016;8:771–782. doi:10.2147/CLEP.S117867
   PubMed Web of Science ®Google Scholar
• Suissa S, Dell’Aniello S, Ernst P. Comparative effectiveness of LABA-ICS versus LAMA as initial treatment in COPD targeted by blood eosinophils: a population-based cohort study. Lancet Respir Med. 2018;6(11):855–862. doi:10.1016/S2213-2600(18)30368-0
   PubMed Web of Science ®Google Scholar
• Johnson ES, Bartman BA, Briesacher BA, et al. The incident user design in comparative effectiveness research. Pharmacoepidemiol Drug Saf. 2013;22(1):1–6. doi:10.1002/pds.3334
   PubMed Web of Science ®Google Scholar
• Suissa S, Moodie EE, Dell’Aniello S. Prevalent new-user cohort designs for comparative drug effect studies by time-conditional propensity scores. Pharmacoepidemiol Drug Saf. 2017;26(4):459–468. doi:10.1002/pds.4107
   PubMed Web of Science ®Google Scholar
• Meropol SB, Metlay JP. Accuracy of pneumonia hospital admissions in a primary care electronic medical record database. Pharmacoepidemiol Drug Saf. 2012;21(6):659–665. doi:10.1002/pds.3207
   PubMed Web of Science ®Google Scholar
• Suissa S, Dell’Aniello S, Ernst P. Comparative effectiveness and safety of LABA-LAMA vs LABA-ICS treatment of COPD in Real-world clinical practice. CHEST. 2019;155(6):1158–1165. doi:10.1016/j.chest.2019.03.005
   PubMed Web of Science ®Google Scholar
• Suissa S, Dell’Aniello S, Ernst P. Comparative effectiveness of initial LAMA versus LABA in COPD: real-world cohort study. J Chronic Obstructive Pulmonary Dis. 2021;18(1):1–8. doi:10.1080/15412555.2021.1877649
   PubMed Web of Science ®Google Scholar
• Rebordosa C, Plana E, Aguado J, et al. GOLD assessment of COPD severity in the Clinical Practice Research Datalink (CPRD). Pharmacoepidemiol Drug Saf. 2019;28(2):126–133. doi:10.1002/pds.4448
   PubMed Web of Science ®Google Scholar
• Whittaker HR, Pimenta JM, Jarvis D, Kiddle SJ, Quint JK. Characteristics associated with accelerated lung function decline in a primary care population with chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2020;15:3079–3091. doi:10.2147/COPD.S278981
   PubMed Web of Science ®Google Scholar
• Quanjer PH, Stanojevic S, Cole TJ, et al. Multi-ethnic reference values for spirometry for the 3–95-yr age range: the global lung function 2012 equations. Eur Respir J. 2012;40(6):1324–1343. doi:10.1183/09031936.00080312
   PubMed Web of Science ®Google Scholar
• Desai RJ, Franklin JM. Alternative approaches for confounding adjustment in observational studies using weighting based on the propensity score: a primer for practitioners. BMJ. 2019;367:l5657. doi:10.1136/bmj.l5657
   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
• Rothnie KJ, Müllerová H, Hurst JR, et al. Validation of the recording of acute exacerbations of COPD in UK primary care electronic healthcare records. PLoS One. 2016;11(3):e0151357. doi:10.1371/journal.pone.0151357
   PubMed Web of Science ®Google Scholar
• Suissa S. Run-in bias in randomised trials: the case of COPD medications. Eur Respir J. 2017;49(6):1700361. doi:10.1183/13993003.00361-2017
   PubMed Web of Science ®Google Scholar
• Sherman RE, Anderson SA, Dal Pan GJ, et al. Real-world evidence — what is it and what can it tell us? N Engl J Med. 2016;375(23):2293–2297. doi:10.1056/NEJMsb1609216
   PubMed Web of Science ®Google Scholar
• Frieden TR, Drazen JM, Harrington DP, McMurray JJV, Ware JH, Woodcock J. Evidence for health decision making — beyond randomized, controlled trials. N Engl J Med. 2017;377(5):465–475. doi:10.1056/NEJMra1614394
   PubMed Web of Science ®Google Scholar
• Eichler HG, Koenig F, Arlett P, et al. Are novel, nonrandomized analytic methods fit for decision making? The need for prospective, controlled, and transparent validation. Clin Pharmacol Ther. 2020;107(4):773–779. doi:10.1002/cpt.1638
   PubMed Web of Science ®Google Scholar