Fluticasone furoate, vilanterol, and lung function decline in patients with moderate chronic obstructive pulmonary disease and heightened cardiovascular risk

American Journal of Respiratory and Critical Care Medicine

Volumn 197, Issue 1, 2018, Pages 47-55

  Calverley, Peter M A ^a,b   Anderson, Julie A ^c   Brook, Robert D ^d   Crim, Courtney ^e   Gallot, Natacha ^f   Kilbride, Sally ^c   Martinez, Fernando J ^d,g   Yates, Julie ^e   Newby, David E ^h   Vestbo, Jørgen ⁱ   Wise, Robert ^j   Celli, Bartolomé R ^k  

^a UNIVERSITY OF LIVERPOOL   (United Kingdom)

^b UNIVERSITY HOSPITAL AINTREE   (United Kingdom)

^c GLAXOSMITHKLINE   (United Kingdom)

^d UNIVERSITY OF MICHIGAN HEALTH SYSTEM   (United States)

^e GLAXOSMITHKLINE   (United States)

^f Veramed Ltd ^*  (United Kingdom)

^g WEILL CORNELL MEDICAL COLLEGE   (United States)

^h UNIVERSITY OF EDINBURGH   (United Kingdom)

ⁱ UNIVERSITY OF MANCHESTER   (United Kingdom)

^j JOHNS HOPKINS UNIVERSITY   (United States)

^k BRIGHAM AND WOMEN S HOSPITAL   (United States)

more..

Author keywords

COPD; Fluticasone furoate; Rate of decline in FEV1; Vilanterol

Indexed keywords

FLUTICASONE FUROATE; SALBUTAMOL; VILANTEROL; BENZYL ALCOHOL DERIVATIVE; CHLOROBENZENE; FLUTICASONE;

ADULT; AGED; ARTICLE; BODY MASS; CARDIOVASCULAR DISEASE; CARDIOVASCULAR RISK; CHRONIC OBSTRUCTIVE LUNG DISEASE; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; EOSINOPHIL COUNT; FEMALE; FORCED EXPIRATORY VOLUME; HUMAN; INTENTION TO TREAT ANALYSIS; LUNG FUNCTION; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; SMOKING; SPIROMETRY; CLINICAL TRIAL; COMBINATION DRUG THERAPY; COMPLICATION; DOSE RESPONSE; DRUG ADMINISTRATION; DRUG EFFECT; INTERNATIONAL COOPERATION; MIDDLE AGED; MORTALITY; MULTICENTER STUDY; PROCEDURES; PROGNOSIS; REFERENCE VALUE; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

ADULT; AGED; BENZYL ALCOHOLS; CARDIOVASCULAR DISEASES; CHLOROBENZENES; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; DRUG THERAPY, COMBINATION; FEMALE; FLUTICASONE; FORCED EXPIRATORY VOLUME; HUMANS; INTERNATIONALITY; MALE; MIDDLE AGED; PROGNOSIS; PROSPECTIVE STUDIES; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; REFERENCE VALUES; SEVERITY OF ILLNESS INDEX; SPIROMETRY; TREATMENT OUTCOME;

EID: 85039852333     PISSN: 1073449X     EISSN: 15354970     Source Type: Journal    
DOI: 10.1164/rccm.201610-2086OC     Document Type: Article

References (37)

1. Vestbo J, Hurd SS, Agustí AG, Jones PW, Vogelmeier C, Anzueto A, et al. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med 2013;187:347–365.
2. Peat JK, Woolcock AJ, Cullen K. Decline of lung function and development of chronic airflow limitation: a longitudinal study of non-smokers and smokers in Busselton, Western Australia. Thorax 1990;45:32–37.
3. Fletcher C, Peto R. The natural history of chronic airflow obstruction. BMJ 1977;1:1645–1648.
4. 1: the Lung Health Study. JAMA 1994;272:1497–1505.
5. Burge PS, Calverley PM, Jones PW, Spencer S, Anderson JA, Maslen TK. Randomised, double blind, placebo controlled study of fluticasone propionate in patients with moderate to severe chronic obstructive pulmonary disease: the ISOLDE trial. BMJ 2000;320:1297–1303.
6. Casanova C, Aguirre-Jaíme A, de Torres JP, Pinto-Plata V, Baz R, Marin JM, et al. Longitudinal assessment in COPD patients: multidimensional variability and outcomes. Eur Respir J 2014;43:745–753.
7. Vestbo J, Edwards LD, Scanlon PD, Yates JC, Agusti A, Bakke P, et al.; ECLIPSE Investigators. Changes in forced expiratory volume in 1 second over time in COPD. N Engl J Med 2011;365:1184–1192.
8. Nishimura M, Makita H, Nagai K, Konno S, Nasuhara Y, Hasegawa M, et al.; Hokkaido COPD Cohort Study Investigators. Annual change in pulmonary function and clinical phenotype in chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2012;185:44–52.
9. Kohansal R, Soriano JB, Agusti A. Investigating the natural history of lung function: facts, pitfalls, and opportunities. Chest 2009;135: 1330–1341.
10. 1. Eur Respir J 1989;2:811–816.
11. Scanlon PD, Connett JE, Waller LA, Altose MD, Bailey WC, Buist AS, et al.; Lung Health Study Research Group. Smoking cessation and lung function in mild-to-moderate chronic obstructive pulmonary disease: the Lung Health Study. Am J Respir Crit Care Med 2000;161:381–390.
12. Troosters T, Celli B, Lystig T, Kesten S, Mehra S, Tashkin DP, et al.; Uplift Investigators. Tiotropium as a first maintenance drug in COPD: secondary analysis of the UPLIFT trial. Eur Respir J 2010;36:65–73.
13. Decramer M, Celli B, Kesten S, Lystig T, Mehra S, Tashkin DP; UPLIFT investigators. Effect of tiotropium on outcomes in patients with moderate chronic obstructive pulmonary disease (UPLIFT): a prespecified subgroup analysis of a randomised controlled trial. Lancet 2009;374:1171–1178.
14. Barnes NC, Qiu YS, Pavord ID, Parker D, Davis PA, Zhu J, et al.; SCO30005 Study Group. Antiinflammatory effects of salmeterol/fluticasone propionate in chronic obstructive lung disease. Am J Respir Crit Care Med 2006;173:736–743.
15. Celli BR, Thomas NE, Anderson JA, Ferguson GT, Jenkins CR, Jones PW, et al. Effect of pharmacotherapy on rate of decline of lung function in chronic obstructive pulmonary disease: results from the TORCH study. Am J Respir Crit Care Med 2008;178:332–338.
16. Lapperre TS, Snoeck-Stroband JB, Gosman MM, Jansen DF, van Schadewijk A, Thiadens HA, et al.; Groningen Leiden Universities Corticosteroids in Obstructive Lung Disease Study Group. Effect of fluticasone with and without salmeterol on pulmonary outcomes in chronic obstructive pulmonary disease: a randomized trial. Ann Intern Med 2009;151:517–527.
17. Vestbo J, Anderson J, Brook RD, Calverley PM, Celli BR, Crim C, et al. The Study to Understand Mortality and Morbidity in COPD (SUMMIT) study protocol. Eur Respir J 2013;41:1017–1022.
18. Vestbo J, Anderson JA, Brook RD, Calverley PM, Celli BR, Crim C, et al.; SUMMIT Investigators. Fluticasone furoate and vilanterol and survival in chronic obstructive pulmonary disease with heightened cardiovascular risk (SUMMIT): a double-blind randomised controlled trial. Lancet 2016;387:1817–1826.
19. Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, et al. Standardisation of spirometry. Eur Respir J 2005;26:319–338.
20. Brown H, Prescott R. Applied mixed models in medicine. 3rd ed. Hoboken, NJ: John Wiley & Sons; 2015.
21. Hankinson JL, Odencrantz JR, Fedan KB. Spirometric reference values from a sample of the general U.S. population. Am J Respir Crit Care Med 1999;159:179–187.
22. Hankinson JL, Kawut SM, Shahar E, Smith LJ, Stukovsky KH, Barr RG. Performance of American Thoracic Society-recommended spirometry reference values in a multiethnic sample of adults: the Multi-Ethnic Study of Atherosclerosis (MESA) Lung Study. Chest 2010;137:138–145.
23. Vestbo J, Sørensen T, Lange P, Brix A, Torre P, Viskum K. Long-term effect of inhaled budesonide in mild and moderate chronic obstructive pulmonary disease: a randomised controlled trial. Lancet 1999;353:1819–1823.
24. Wise R, Connett J, Weinmann G, Scanlon P, Skeans M; Lung Health Study Research Group. Effect of inhaled triamcinolone on the decline in pulmonary function in chronic obstructive pulmonary disease. N Engl J Med 2000;343:1902–1909.
25. Pauwels RA, Löfdahl CG, Laitinen LA, Schouten JP, Postma DS, Pride NB, et al.; European Respiratory Society Study on Chronic Obstructive Pulmonary Disease. Long-term treatment with inhaled budesonide in persons with mild chronic obstructive pulmonary disease who continue smoking. N Engl J Med 1999;340:1948–1953.
26. Kiri VA, Pride NB, Soriano JB, Vestbo J. Inhaled corticosteroids in chronic obstructive pulmonary disease: results from two observational designs free of immortal time bias. Am J Respir Crit Care Med 2005;172:460–464.
27. Sutherland ER, Allmers H, Ayas NT, Venn AJ, Martin RJ. Inhaled corticosteroids reduce the progression of airflow limitation in chronic obstructive pulmonary disease: a meta-analysis. Thorax 2003;58:937–941.
28. Lange P, Celli B, Agustí A, Boje Jensen G, Divo M, Faner R, et al. Lung-function trajectories leading to chronic obstructive pulmonary disease. N Engl J Med 2015;373:111–122.
29. Dransfield MT, Bourbeau J, Jones PW, Hanania NA, Mahler DA, Vestbo J, et al. Once-daily inhaled fluticasone furoate and vilanterol versus vilanterol only for prevention of exacerbations of COPD: two replicate double-blind, parallel-group, randomised controlled trials. Lancet Respir Med 2013;1:210–223.
30. 1 in relative terms. COPD 2014;11:96–104.
31. Celli B, Vestbo J, Jenkins CR, Jones PW, Ferguson GT, Calverley PM, et al.; Investigators of the TORCH Study. Sex differences in mortality and clinical expressions of patients with chronic obstructive pulmonary disease: the TORCH experience. Am J Respir Crit Care Med 2011;183:317–322.
32. Barnes PJ. Sex differences in chronic obstructive pulmonary disease mechanisms. Am J Respir Crit Care Med 2016;193:813–814.
33. Martinez FJ, Vestbo J, Anderson JA, Brook RD, Celli BR, Cowans NJ, et al.; SUMMIT Investigators. Effect of fluticasone furoate and vilanterol on exacerbations of chronic obstructive pulmonary disease in patients with moderate airflow obstruction. Am J Respir Crit Care Med 2017;195:881–888.
34. Calverley PM, Spencer S, Willits L, Burge PS, Jones PW; IOSLDE Study Group. Withdrawal from treatment as an outcome in the ISOLDE study of COPD. Chest 2003;124:1350–1356.
35. Vestbo J, Anderson JA, Calverley PM, Celli B, Ferguson GT, Jenkins C, et al. Bias due to withdrawal in long-term randomised trials in COPD: evidence from the TORCH study. Clin Respir J 2011;5:44–49.
36. Barnes NC, Sharma R, Lettis S, Calverley PM. Blood eosinophils as a marker of response to inhaled corticosteroids in COPD. Eur Respir J 2016;47:1374–1382.
37. 1 decline and chronic obstructive pulmonary disease morbidity. Am J Respir Crit Care Med 1996;153:1530–1535.