The study to understand mortality and morbidity in COPD (SUMMIT) study protocol

European Respiratory Journal

Volumn 41, Issue 5, 2013, Pages 1017-1022

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

^a ODENSE UNIVERSITY HOSPITAL   (Denmark)

^b UNIVERSITY OF MANCHESTER   (United Kingdom)

^c GLAXOSMITHKLINE   (United Kingdom)

^d UNIVERSITY OF MICHIGAN HEALTH SYSTEM   (United States)

^e UNIVERSITY OF LIVERPOOL   (United Kingdom)

^f BRIGHAM AND WOMEN S HOSPITAL   (United States)

^g GLAXOSMITHKLINE   (United States)

^h UNIVERSITY OF EDINBURGH   (United Kingdom)

Author keywords

Cardiovascular disease; Chronic obstructive pulmonary disease; Mortality

Indexed keywords

FLUTICASONE FUROATE; PLACEBO; VILANTEROL;

ARTICLE; CHRONIC OBSTRUCTIVE LUNG DISEASE; CLINICAL PROTOCOL; CONTROLLED STUDY; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FORCED EXPIRATORY VOLUME; HUMAN; MAJOR CLINICAL STUDY; MORBIDITY; MORTALITY; MULTICENTER STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; STUDY DESIGN;

CARDIOVASCULAR DISEASE; CHRONIC OBSTRUCTIVE PULMONARY DISEASE; MORTALITY;

ADMINISTRATION, INHALATION; ADULT; AGED; AGED, 80 AND OVER; ANDROSTADIENES; BENZYL ALCOHOLS; CARDIOVASCULAR DISEASES; CHLOROBENZENES; DOUBLE-BLIND METHOD; FEMALE; FORCED EXPIRATORY VOLUME; HEALTH STATUS; HUMANS; INTERNATIONAL COOPERATION; MALE; MIDDLE AGED; PROGNOSIS; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; TIME FACTORS; TREATMENT OUTCOME;

EID: 84877088995     PISSN: 09031936     EISSN: 13993003     Source Type: Journal    
DOI: 10.1183/09031936.00087312     Document Type: Article

References (40)

1. Vestbo J, Hurd SS, Agusti AG, 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. Fabbri LM, Luppi F, Beghé B, et al. Complex chronic comorbidities of COPD. Eur Respir J 2008; 31: 204-212.
3. Mannino DM, Thorn D, Swensen A, et al. Prevalence and outcomes of diabetes, hypertension and cardiovascular disease in COPD. Eur Respir J 2008; 32: 962-969.
4. Agusti AG, Sauleda J, Miralles C, et al. Skeletal muscle apoptosis and weight loss in chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2002; 166: 485-489.
5. Vestbo J, Prescott E, Almdal T, et al. Body mass, fat free body mass and prognosis in COPD patients from a random population sample. Am J Respir Crit Care Med 2006; 173: 79-83.
6. Bolton CE, Ionescu AA, Shiels KM, et al. Associated loss of fat-free mass and bone mineral density in chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2004; 170: 1286-1293. (Pubitemid 39657192)
7. 1: a new risk factor for coronary heart disease mortality. Am J Respir Crit Care Med 1995; 151: 390-398.
8. 1 and peripheral blood leukocyte count to total mortality. The normative Aging Study. Am J Epidemiol 1995; 42: 493-498.
9. Hole DJ, Watt GCM, Davey-Smith G, et al. Impaired lung function and mortality risk in men and females: findings from the Renfrew and Paisley prospective population study. BMJ 1996; 313: 711-715.
10. Tashkin DP, Celli B, Senn S, et al. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med 2008; 359: 1543-1554.
11. Curkendall SM, DeLuise C, Jones JK, et al. Cardiovascular disease in patients with chronic obstructive pulmonary disease, Saskatchewan Canada cardiovascular disease in COPD. Am J Epidemiol 2006; 16: 63-70. (Pubitemid 41783891)
12. Anthonisen NR, Skeans MA, Wise RA, et al. The effects of a smoking cessation intervention on a 14.5-year mortality. Ann Intern Med 2005; 142: 233-239. (Pubitemid 40216240)
13. Mannino DM, Watt G, Hole D, et al. The natural history of chronic obstructive pulmonary disease. Eur Respir J 2006; 27: 627-643. (Pubitemid 43372539)
14. Calverley PMA, Anderson JA, Celli B, et al. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N Engl J Med 2007; 356: 775-789. (Pubitemid 46294610)
15. Sin DD, Man SFP. 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 2003; 107: 1514-1519. (Pubitemid 36378490)
16. Watz H, Waschki B, Meyer T, et al. Physical activity in patients with COPD. Eur Respir J 2009; 33: 262-272.
17. Calverley PMA, Anderson JA, Celli B, et al. Cardiovascular events in patients with chronic obstructive pulmonary disease: TORCH study results. Thorax 2010; 65: 719-725.
18. Hankinson JL, Odencrantz JR, Fedan KB. Spirometric reference values from a sample of the general US population. Am J Respir Crit Care Med 1999; 159: 179-187. (Pubitemid 29036522)
19. Hankinson JL, Kawut SM, Shahar E, et al. Performance of American Thoracic Society recommended spirometry reference values in a multiethnic sample of adults. Chest 2010; 137: 138-145.
20. 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: 411-415. (Pubitemid 46698390)
21. Hogg JC, Macklem PT, Thurlbeck WM. Site and nature of airway obstruction in chronic obstructive lung disease. N Engl J Med 1968; 278: 1355-1360.
22. Hogg JC, Chu F, Utokaparch S, et al. The nature of small-airway obstruction in chronic obstructive pulmonary disease. N Engl J Med 2004; 350: 2645-2653. (Pubitemid 38787999)
23. Sevenoaks MJ, Stockley RA. Chronic obstructive pulmonary disease, inflammation and co-morbidity - a common inflammatory phenotype. Respir Res 2006; 7: 70.
24. Lakatta EG. Arterial and cardiac aging: major shareholders in cardiovascular disease enterprises. Part III: cellular and molecular clues to heart and arterial aging. Circulation 2003; 107: 490-497. (Pubitemid 36158054)
25. Laurent S, Boutouyrie P, Asmar R, et al. Aortic stiffness is an independent predictor of all-cause mortality an cardiovascular mortality in hypertensive patients. Hypertension 2001; 37: 1236-1241. (Pubitemid 34163575)
26. Boutouyrie P, Tropeano AI, Asmar R, et al. Aortic stiffness is an independent predictor of primary coronary events in hypertensive patients; a longitudinal study. Hypertension 2002; 39: 10-15. (Pubitemid 34098081)
27. Laurent S, Katsahian S, Fassot C, et al. Aortic stiffness is an independent predictor of fatal stroke in essential hypertension. Stroke 2003; 34: 1203-1206. (Pubitemid 36547514)
28. Sutton-Tyrrell K, Najjar SS, Boudreau RM, et al. Elevated aortic pulse wave velocity, a marker of arterial stiffness, predicts cardiovascular events in well-functioning older adults. Circulation 2005; 111: 3384-3390. (Pubitemid 40923391)
29. Hansen TW, Staessen JA, Torp-Pedersen C, et al. Prognostic value of aortic pulse wave velocity as index of arterial stiffness in the general population. Circulation 2006; 113: 664-670.
30. Zureik M, Benetos A, Neukirch C, et al. Reduced pulmonary function is associated with central arterial stiffness in men. Am J Respir Crit Care Med 2001; 164: 2181-2185. (Pubitemid 34032932)
31. Sabit R, Bolton CE, Edwards PH, et al. Arterial stiffness and osteoporosis in chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2007; 175: 1259-1265. (Pubitemid 46905751)
32. Celli BR, Locantore N, Yates J, et al. Inflammatory biomarkers improve clinical prediction of mortality in chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2012; 185: 1065-1072.
33. Mills NL, Miller JJ, Anand A, et al. Increased arterial stiffness in patients with chronic obstructive pulmonary disease: a mechanism for increased cardiovascular risk. Thorax 2008; 63: 306-311. (Pubitemid 351497941)
34. Ridker PM. High sensitivity C-reactive protein, inflammation, and cardiovascular risk: from concept to clinical practice to clinical benefit. Am Heart J 2004; 148: Suppl. 1, S19-S26. (Pubitemid 38887094)
35. McAllister DA, Maclay JD, Mills NL, et al. Arterial stiffness is independently associated with emphysema in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2007; 176: 1208-1214. (Pubitemid 350256474)
36. Yang IA, Fong KM, Sim EH, et al. Inhaled corticosteroids for stable chronic obstructive pulmonary disease. Cochrane Database Syst Rev 2007; 2: CD002991.
37. Nannini LJ, Cates CJ, Lasserson TJ, et al. Combined corticosteroid and long-acting β-agonist in one inhaler versus long-acting β-agonists for chronic obstructive pulmonary disease. Cochrane Database Syst Rev 2007; 4: CD006829.
38. McAllister DA, Maclay JD, Mills NL, et al. Diagnosis of myocardial infarction following hospitalization for exacerbation of COPD. Eur Respir J 2012; 39: 1097-1103.
39. Löfdahl C-G, Postma DS, Pride NB, et al. Possible protection by inhaled budesonide against ischaemic cardiac events in mild COPD. Eur Respir J 2007; 29: 1115-1159.
40. Vestbo J, Anderson JA, Calverley PMA, 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.