Tiotropium might improve survival in subjects with COPD at high risk of mortality

Respiratory Research

Volumn 15, Issue 1, 2014, Pages

  Burgel, Pierre Régis ^a,b   Paillasseur, Jean Louis ^c   Dusser, Daniel ^a,b   Roche, Nicolas ^a,b   Liu, Dacheng ^d   Liu, Yufeng ^e   Furtwaengler, Armin ^f   Metzdorf, Norbert ^f   Decramer, Marc ^g  

^a ASSISTANCE PUBLIQUE HÔPITAUX DE PARIS   (France)

^b UNIVERSITÉ PARIS DESCARTES   (France)

^c Clindatafirst   (France)

^d BOEHRINGER INGELHEIM PHARMACEUTICALS INC   (United States)

^e UNIVERSITY OF NORTH CAROLINA   (United States)

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

^g UNIVERSITY OF LEUVEN   (Belgium)

Author keywords

COPD; Exacerbations; Mortality; Tiotropium

Indexed keywords

TIOTROPIUM BROMIDE; BRONCHODILATING AGENT; SCOPOLAMINE DERIVATIVE;

ADULT; AGED; ARTICLE; BODY MASS; CHRONIC OBSTRUCTIVE LUNG DISEASE; CLUSTER ANALYSIS; CONTROLLED STUDY; DISEASE EXACERBATION; DRUG SCREENING; FEMALE; FOLLOW UP; FORCED EXPIRATORY VOLUME; HIGH RISK PATIENT; HOSPITALIZATION; HUMAN; LOW RISK PATIENT; MAJOR CLINICAL STUDY; MALE; MORTALITY; OUTCOME ASSESSMENT; PATIENT CODING; PATIENT IDENTIFICATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); RESPIRATORY AIRFLOW; SMOKING; ST. GEORGE RESPIRATORY QUESTIONNAIRE; SURVIVAL; CONTROLLED CLINICAL TRIAL; DOUBLE BLIND PROCEDURE; MIDDLE AGED; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL; RISK FACTOR; SURVIVAL RATE;

AGED; BRONCHODILATOR AGENTS; DOUBLE-BLIND METHOD; FEMALE; FOLLOW-UP STUDIES; HUMANS; MALE; MIDDLE AGED; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; RISK FACTORS; SCOPOLAMINE DERIVATIVES; SURVIVAL RATE;

EID: 84902539786     PISSN: 14659921     EISSN: 1465993X     Source Type: Journal    
DOI: 10.1186/1465-9921-15-64     Document Type: Article

References (21)

1. Halbert RJ, Natoli JL, Gano A, Badamgarav E, Buist AS, Mannino DM. Global burden of COPD: systematic review and meta-analysis. Eur Respir J 2006, 28:523-532. 10.1183/09031936.06.00124605, 16611654.
2. Decramer M, Janssens W, Miravitlles M. Chronic obstructive pulmonary disease. Lancet 2012, 379:1341-1351. 10.1016/S0140-6736(11)60968-9, 22314182.
3. Calverley PM, Anderson JA, Celli B, Ferguson GT, Jenkins C, Jones PW, Yates JC, Vestbo J. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N Engl J Med 2007, 356:775-789. 10.1056/NEJMoa063070, 17314337.
4. Tashkin DP, Celli B, Senn S, Burkhart D, Kesten S, Menjoge S, Decramer M. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med 2008, 359:1543-1554. 10.1056/NEJMoa0805800, 18836213.
5. Celli B, Decramer M, Kesten S, Liu D, Mehra S, Tashkin DP. Mortality in the 4-year trial of tiotropium (UPLIFT) in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2009, 180:948-955. 10.1164/rccm.200906-0876OC, 19729663.
6. Vestbo J, Hurd SS, Agusti AG, Jones PW, Vogelmeier C, Anzueto A, Barnes PJ, Fabbri LM, Martinez FJ, Nishimura M, Stockley RA, Sin DD, Rodriguez-Roisin R. 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. 10.1164/rccm.201204-0596PP, 22878278.
7. Ioannidis JP, Lau J. The impact of high-risk patients on the results of clinical trials. J Clin Epidemiol 1997, 50:1089-1098. 10.1016/S0895-4356(97)00149-2, 9368516.
8. Kent DM, Hayward RA. Limitations of applying summary results of clinical trials to individual patients: the need for risk stratification. JAMA 2007, 298:1209-1212. 10.1001/jama.298.10.1209, 17848656.
9. Burgel PR, Paillasseur JL, Dusser D, Roche N, Liu D, Liu Y, Furtwaengler A, Metzdorf N, Decramer M. Variations in mortality risk among COPD patients in clinical trials: Data from the UPLIFT study [abstract]. Am J Respir Crit Care Med 2013, 187:A5558.
10. Decramer M, Celli B, Tashkin DP, Pauwels RA, Burkhart D, Cassino C, Kesten S. Clinical trial design considerations in assessing long-term functional impacts of tiotropium in COPD: the UPLIFT trial. COPD 2004, 1:303-312. 10.1081/COPD-200026934, 17136995.
11. McGarvey LP, Magder S, Burkhart D, Kesten S, Liu D, Manuel RC, Niewoehner DE. Cause-specific mortality adjudication in the UPLIFT(R) COPD trial: findings and recommendations. Respir Med 2012, 106:515-521. 10.1016/j.rmed.2011.10.009, 22100536.
12. Puhan MA, Garcia-Aymerich J, Frey M, ter RG, Anto JM, Agusti AG, Gomez FP, Rodriguez-Roisin R, Moons KG, Kessels AG, et al. Expansion of the prognostic assessment of patients with chronic obstructive pulmonary disease: the updated BODE index and the ADO index. Lancet 2009, 374:704-711. 10.1016/S0140-6736(09)61301-5, 19716962.
13. Celli BR, Cote CG, Marin JM, Casanova C, Montes de OM, Mendez RA, Pinto PV, Cabral HJ. The body-mass index, airflow obstruction, dyspnea, and exercise capacity index in chronic obstructive pulmonary disease. N Engl J Med 2004, 350:1005-1012. 10.1056/NEJMoa021322, 14999112.
14. Esteban C, Quintana JM, Aburto M, Moraza J, Egurrola M, Espana PP, Perez-Izquierdo J, Capelastegui A. Predictors of mortality in patients with stable COPD. J Gen Intern Med 2008, 23:1829-1834. 10.1007/s11606-008-0783-x, 2585660, 18795373.
15. Hersh CP, DeMeo DL, Al-Ansari E, Carey VJ, Reilly JJ, Ginns LC, Silverman EK. Predictors of survival in severe, early onset COPD. Chest 2004, 126:1443-1451. 10.1378/chest.126.5.1443, 15539711.
16. Domingo-Salvany A, Lamarca R, Ferrer M, Garcia-Aymerich J, Alonso J, Felez M, Khalaf A, Marrades RM, Monso E, Serra-Batlles J, Anto JM. Health-related quality of life and mortality in male patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2002, 166:680-685. 10.1164/rccm.2112043, 12204865.
17. Burgel PR, Paillasseur JL, Caillaud D, Tillie-Leblond I, Chanez P, Escamilla R, Court-Fortune I, Perez T, Carre P, Roche N. Clinical COPD phenotypes: a novel approach using principal component and cluster analyses. Eur Respir J 2010, 36:531-539. 10.1183/09031936.00175109, 20075045.
18. Webinar draft GFI on enrichment strategies for clinical trials to support approval of human drugs and biological products. http://www.fda.gov/Drugs/ucm343578.htm.
19. Hoogendoorn M, Hoogenveen RT, Rutten-van Molken MP, Vestbo J, Feenstra TL. Case fatality of COPD exacerbations: a meta-analysis and statistical modelling approach. Eur Respir J 2011, 37:508-515. 10.1183/09031936.00043710, 20595157.
20. Piquet J, Chavaillon JM, David P, Martin F, Blanchon F, Roche N. High-risk patients following hospitalisation for an acute exacerbation of COPD. Eur Respir J 2013, 42:946-955. 10.1183/09031936.00180312, 23349446.
21. Soler-Cataluna JJ, Martinez-Garcia MA, Roman SP, Salcedo E, Navarro M, Ochando R. Severe acute exacerbations and mortality in patients with chronic obstructive pulmonary disease. Thorax 2005, 60:925-931. 10.1136/thx.2005.040527, 1747235, 16055622.