Fluticasone furoate and vilanterol and survival in chronic obstructive pulmonary disease with heightened cardiovascular risk (SUMMIT): A double-blind randomised controlled trial

The Lancet

Volumn 387, Issue 10030, 2016, Pages 1817-1826

  Vestbo, Jørgen ^a,i   Anderson, Julie A ^b   Brook, Robert D ^c   Calverley, Peter M A ^d   Celli, Bartolome R ^e   Crim, Courtney ^f   Martinez, Fernando ^c,g   Yates, Julie ^f   Newby, David E ^h  

^a UNIVERSITY OF MANCHESTER   (United Kingdom)

^b GLAXOSMITHKLINE   (United Kingdom)

^c UNIVERSITY OF MICHIGAN HEALTH SYSTEM   (United States)

^d UNIVERSITY OF LIVERPOOL   (United Kingdom)

^e HARVARD MEDICAL SCHOOL   (United States)

^f GLAXOSMITHKLINE   (United States)

^g WEILL CORNELL MEDICAL COLLEGE   (United States)

^h UNIVERSITY OF EDINBURGH   (United Kingdom)

ⁱ MANCHESTER UNIVERSITY NHS FOUNDATION TRUST   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

FLUTICASONE FUROATE; FLUTICASONE FUROATE PLUS VILANTEROL; VILANTEROL; BENZYL ALCOHOL DERIVATIVE; BRONCHODILATING AGENT; CHLOROBENZENE; FLUTICASONE;

ADRENAL DISEASE; ADRENAL SUPPRESSION; ADULT; AGED; ARTICLE; BODY MASS; BONE DISEASE; CARDIOVASCULAR RISK; CHRONIC OBSTRUCTIVE LUNG DISEASE; CONTROLLED STUDY; CORTICOSTEROID THERAPY; DIABETES MELLITUS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; EYE DISEASE; FEMALE; FORCED EXPIRATORY VOLUME; FORCED VITAL CAPACITY; FRACTURE; HEART ARRHYTHMIA; HUMAN; HYPERGLYCEMIA; HYPERKALEMIA; HYPERSENSITIVITY; HYPOKALEMIA; INTENTION TO TREAT ANALYSIS; LOWER RESPIRATORY TRACT INFECTION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OUTCOME ASSESSMENT; PNEUMONIA; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; SMOKING; SURVIVAL; TREMOR; VERY ELDERLY; CARDIOVASCULAR DISEASES; CLINICAL TRIAL; DRUG EFFECTS; MIDDLE AGED; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; RISK FACTOR; TREATMENT OUTCOME;

ADULT; AGED; AGED, 80 AND OVER; BENZYL ALCOHOLS; BRONCHODILATOR AGENTS; CARDIOVASCULAR DISEASES; CHLOROBENZENES; DOUBLE-BLIND METHOD; FEMALE; FLUTICASONE; FORCED EXPIRATORY VOLUME; HUMANS; MALE; MIDDLE AGED; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; RISK FACTORS; TREATMENT OUTCOME;

EID: 84968779698     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(16)30069-1     Document Type: Article

References (28)

1. J Vestbo, SS Hurd, AG Agusti et al. Global strategy for the diagnosis, management and prevention of chronic obstructive pulmonary disease, GOLD Executive Summary Am J Respir Crit Care Med 187 2013 347 365
2. DD Sin, NR Anthonisen, JB Soriano, AG Agusti Mortality in COPD: role of comorbidities Eur Respir J 28 2006 1245 1257
3. LM Fabbri, F Luppi, B Beghé, KF Rabe Complex chronic comorbidities of COPD Eur Respir J 31 2008 204 212
4. DM Mannino, D Thorn, A Swensen, F Holguin Prevalence and outcomes of diabetes, hypertension and cardiovascular disease in COPD Eur Respir J 32 2008 962 969
5. MS Tockman, JD Pearson, JL Fleg et al. Rapid decline in FEV1: a new risk factor for coronary heart disease mortality Am J Respir Crit Care Med 151 1995 390 398
6. SM Curkendall, C DeLuise, JK Jones et al. Cardiovascular disease in patients with chronic obstructive pulmonary disease, Saskatchewan Canada: cardiovascular disease in COPD Am J Epidemiol 16 2006 63 70
7. DJ Hole, GCM Watt, G Davey-Smith, CL Hart, CR Gillis, VM Hawthorne Impaired lung function and mortality risk in men and women: findings from the Renfrew and Paisley prospective population study BMJ 313 1996 711 715
8. NR Anthonisen, MA Skeans, RA Wise, J Manfreda, RE Kanner, JE Connett The effects of a smoking cessation intervention on a 14·5-year mortality Ann Intern Med 142 2005 233 239
9. PMA Calverley, JA Anderson, B Celli on behalf of the TORCH investigators Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease N Engl J Med 356 2007 775 789
10. DD Sin, SFP Man Why are patients with chronic obstructive pulmonary disease at increased risk of cardiovascular disease? The potential role of systemic inflammation in chronic obstructive pulmonary disease Circulation 107 2003 1514 1519
11. JD Maclay, DA McAllister, NL Mills et al. Vascular dysfunction in chronic obstructive pulmonary disease Am J Respir Crit Care Med 180 2009 513 520
12. H Watz, B Waschki, T Meyer, H Magnussen Physical activity in patients with COPD Eur Respir J 33 2009 262 272
13. J Vestbo, J Anderson, RD Brook et al. The study to understand mortality and morbidity in COPD (SUMMIT) study protocol Eur Respir J 41 2013 1017 1022
14. SR Salpeter, TM Ormiston, EE Salpeter Cardiovascular effects of beta-agonists in patients with asthma and COPD: a meta-analysis Chest 125 2004 2309 2321
15. PMA Calverley, JA Anderson, B Celli on behalf of the TORCH investigators Cardiovascular events in patients with chronic obstructive pulmonary disease: TORCH study results Thorax 65 2010 719 725
16. JL Hankinson, JR Odencrantz, KB Fedan Spirometric reference values from a sample of the general US population Am J Respir Crit Care Med 159 1999 179 187
17. LP McGarvey, M John, JA Anderson, M Zvarich, RA Wise Ascertainment of cause-specific mortality in COPD: operations of the TORCH Clinical Endpoint Committee Thorax 62 2007 411 415
18. P Lange, B Celli, A Agustí et al. Lung-function trajectories leading to chronic obstructive pulmonary disease N Engl J Med 373 2015 111 122
19. TS Lapperre, JB Snoeck-Stroband, MME Gosman et al. Effect of fluticasone with and without salmeterol on pulmonary outcomes in chronic obstructive pulmonary disease. A randomized trial Ann Intern Med 151 2009 517 527
20. BR Celli, NE Thomas, JA Anderson et al. Effect of pharmacotherapy on rate of decline of lung function in COPD: results from the TORCH study Am J Respir Crit Care Med 178 2008 332 338
21. J Vestbo, T Sørensen, P Lange, A Brix, P Torre, K Viskum Long-term effect of inhaled budesonide in mild and moderate chronic obstructive pulmonary disease - a randomised, controlled trial Lancet 353 1999 1819 1823
22. RA Pauwels, C-G Löfdahl, LA Laitinen et al. Long-term treatment with inhaled budesonide in persons with mild chronic obstructive pulmonary disease who continue smoking N Engl J Med 340 1999 1948 1953
23. PS Burge, PM Calverley, PW Jones, S Spencer, JA Anderson, TK Maslen Randomised, double blind, placebo controlled study of fluticasone propionate in patients with moderate to severe chronic obstructive pulmonary disease: the ISOLDE trial BMJ 320 2000 1297 1303
24. The Lung Health Study Research Group Effect of inhaled triamcinolone on the decline in pulmonary function in chronic obstructive pulmonary disease N Engl J Med 343 2000 1902 1909
25. C Crim, PMA Calverley, JA Anderson et al. Pneumonia risk in COPD patients receiving inhaled corticosteroids alone or in combination: TORCH study results Eur Respir J 34 2009 89 94
26. KM Kew, A Seniukovich Inhaled steroids and risk of pneumonia for chronic obstructive pulmonary disease Cochrane Database Syst Rev 10 2014 CD010115
27. C Crim, MT Dransfield, J Bourbeau et al. Pneumonia risk with inhaled fluticasone furoate and vilanterol compared with vilanterol alone in patients with COPD Ann Am Thorac Soc 12 2015 27 34
28. R Zalacain, V Sobradillo, J Amilibia et al. Predisposing factors to bacterial colonization in chronic obstructive pulmonary disease Eur Respir J 13 1999 343 348