Tiotropium versus salmeterol for the prevention of exacerbations of COPD

New England Journal of Medicine

Volumn 364, Issue 12, 2011, Pages 1093-1103

  Vogelmeier, Claus ^a   Hederer, Bettina ^b   Glaab, Thomas ^b   Schmidt, Hendrik ^b   Rutten van Mölken, Maureen P M H ^d   Beeh, Kai M ^c   Rabe, Klaus F ^e   Fabbri, Leonardo M ^f  

^a UNIVERSITY HOSPITAL MARBURG   (Germany)

^b BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

^c Institut fur Atemwegsforschung INSAF   (Germany)

^d ERASMUS UNIVERSITY ROTTERDAM   (Netherlands)

^e LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^f UNIVERSITY OF MODENA AND REGGIO EMILIA   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBIOTIC AGENT; GLUCOCORTICOID; SALMETEROL; SALMETEROL XINAFOATE; TIOTROPIUM BROMIDE;

ADULT; ARTICLE; CARDIOVASCULAR DISEASE; CHRONIC OBSTRUCTIVE LUNG DISEASE; CONNECTIVE TISSUE DISEASE; CONTROLLED STUDY; DISEASE EXACERBATION; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; GASTROINTESTINAL DISEASE; HEART DISEASE; HUMAN; INFECTION; INJURY; INTOXICATION; MAJOR CLINICAL STUDY; MALE; MEDIASTINUM DISEASE; MUSCULOSKELETAL DISEASE; NEOPLASM; NEUROLOGIC DISEASE; PNEUMONIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT DISEASE; RISK REDUCTION; THORAX DISEASE; TREATMENT DURATION; TREATMENT RESPONSE;

EID: 79953166862     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa1008378     Document Type: Article

References (31)

1. Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: 2009 update. (http://www.goldcopd.com.)
2. National Institute for Health and Clinical Excellence. Chronic obstructive pulmonary disease: management of chronic obstructive pulmonary disease in adults in primary and secondary care. London: National Clinical Guideline Centre, 2010. (http://guidance.nice.org.uk/CG101/Guidance/pdf/English. )
3. Niewoehner DE. Outpatient management of severe COPD. N Engl J Med 2010;362:1407-16.
4. Donaldson GC, Seemungal TAR, Bhowmik A, Wedzicha JA. Relationship between exacerbation frequency and lung function decline in chronic obstructive pulmonary disease. Thorax 2002;57:847-52. [Erratum, Thorax 2008;63:753.]
5. Soler-Cataluña JJ, Martínez-García MÁ, Román Sánchez P, Salcedo E, Navarro M, Ochando R. Severe acute exacerbations and mortality in patients with chronic obstructive pulmonary disease. Thorax 2005;60:925-31. (Pubitemid 41598207)
6. Wedzicha JA, Seemungal TA. COPD exacerbations: defining their cause and prevention. Lancet 2007;370:786-96. (Pubitemid 47320802)
7. Hurst JR, Vestbo J, Anzueto A, et al. Susceptibility to exacerbation in chronic obstructive pulmonary disease. N Engl J Med 2010;363:1128-38.
8. Calverley PMA, Anderson JA, Celli B, et al. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N Engl J Med 2007;356:775-89. (Pubitemid 46294610)
9. Casaburi R, Mahler DA, Jones PW, et al. A long-term evaluation of once-daily inhaled tiotropium in chronic obstructive pulmonary disease. Eur Respir J 2002;19:217-24. (Pubitemid 34162820)
10. Mahler DA, Donohue JF, Barbee RA, et al. Efficacy of salmeterol xinafoate in the treatment of COPD. Chest 1999;115:957-65. (Pubitemid 29193661)
11. 2-adrenergic agonist, salmeterol xinafoate, in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2001;163:1087-92.
12. Tashkin DP, Celli B, Senn S, et al. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med 2008;359:1543-54.
13. Briggs DD Jr, Covelli H, Lapidus R, Bhattycharya S, Kesten S, Cassino C. Improved daytime spirometric efficacy of tiotropium compared with salmeterol in patients with COPD. Pulm Pharmacol Ther 2005;18:397-404. (Pubitemid 41354265)
14. Brusasco V, Hodder R, Miravitlles M, Korducki L, Towse L, Kesten S. Health outcomes following treatment for six months with once daily tiotropium compared with twice daily salmeterol in patients with COPD. Thorax 2003;58:399-404. [Erratum, Thorax 2005;60:105.]
15. Mushlin AI, Ghomrawi H. Health care reform and the need for comparative-effectiveness research. N Engl J Med 2010;362(3):e6. (Available at NEJM.org.)
16. Sawicki PT. Communal responsibility for health care - the example of benefit assessment in Germany. N Engl J Med 2009;361(20):e42. (Available at NEJM.org.)
17. Beeh KM, Hederer B, Glaab T, et al. Study design considerations in a large COPD trial comparing effects of tiotropium with salmeterol on exacerbations. Int J Chron Obstruct Pulmon Dis 2009;4:119-25.
18. Quanjer PH, Tammeling GJ, Cotes JE, Pedersen OF, Peslin R, Yernault JC. Lung volumes and forced ventilatory flows: Report Working Party Standardization of Lung Function Tests, European Community for Steel and Coal: official statement of the European Respiratory Society. Eur Respir J Suppl 1993;16:5-40.
19. American Thoracic Society. Standardization of spirometry, 1994 update. Am J Respir Crit Care Med 1995;152:1107-36.
20. Keene ON, Vestbo J, Anderson JA, et al. Methods for therapeutic trials in COPD: lessons from the TORCH trial. Eur Respir J 2009;34:1018-23.
21. Bateman ED, Rennard S, Barnes PJ, et al. Alternative mechanisms for tiotropium. Pulm Pharmacol Ther 2009;22:533-42.
22. Johnson M, Rennard S. Alternative mechanisms for long-acting beta(2)-adrenergic agonists in COPD. Chest 2001;120:258-70.
23. Calverley P, Pauwels R, Vestbo J, et al. Combined salmeterol and fluticasone in the treatment of chronic obstructive pulmonary disease: a randomised controlled trial. Lancet 2003;361:449-56. [Erratum, Lancet 2003;361:1660.]
24. Dahl R, Chung KF, Buhl R, et al. Efficacy of a new once-daily long-acting inhaled beta2-agonist indacaterol versus twice-daily formoterol in COPD. Thorax 2010;65:473-9.
25. Wouters EF, Postma DS, Fokkens B, et al. Withdrawal of fluticasone propionate from combined salmeterol/fluticasone treatment in patients with COPD causes immediate and sustained disease deterioration: a randomised controlled trial. Thorax 2005;60:480-7. (Pubitemid 40814047)
26. Calverley PM, Spencer S, Willits L, Burge PS, Jones PW. Withdrawal from treatment as an outcome in the ISOLDE study of COPD. Chest 2003;124:1350-6. (Pubitemid 37290045)
27. Niewoehner DE, Rice K, Cote C, et al. Prevention of exacerbations of chronic obstructive pulmonary disease with tiotropium, a once-daily inhaled anticholinergic bronchodilator: a randomized trial. Ann Intern Med 2005;143:317-26.
28. Celli B, Decramer M, Leimer I, Vogel U, Kesten S, Tashkin DP. Cardiovascular safety of tiotropium in patients with COPD. Chest 2010;137:20-30.
29. Kesten S, Celli B, Decramer M, Leimer I, Tashkin D. Tiotropium HandiHaler in the treatment of COPD: a safety review. Int J Chron Obstruct Pulmon Dis 2009;4:397-409.
30. Ferguson GT, Funck-Brentano C, Fischer T, Darken P, Reisner C. Cardiovascular safety of salmeterol in COPD. Chest 2003;123:1817-24.
31. Calverley PMA, Anderson JA, Celli B, et al. Cardiovascular events in patients with COPD: TORCH study results. Thorax 2010;65:719-25.