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Eur Respir J 2002; 19:209-216
Copyright ©ERS Journals Ltd 2002

Improved health outcomes in patients with COPD during 1 yr's treatment with tiotropium

W. Vincken1, J.A. van Noord2, A.P.M. Greefhorst3, Th.A. Bantje4, S. Kesten5, L. Korducki5 and P.J.G. Cornelissen6

1 Respiratory Division, Academic Hospital University of Brussels (AZ VUB), Brussels, Belgium. 2 Dept of Respiratory Diseases, Atrium Medisch Centrum, Heerlen, the Netherlands. 3 Dept of Respiratory Diseases, St Streekziekenhuis Midden Twente, Hengelo, the Netherlands. 4 Dept of Respiratory Diseases, Ignatius and Barouie Hospitals, Breda, the Netherlands. 5 Boehringer Ingelheim, Ridgefield, CT, USA. 6 Boehringer Ingelheim, Alkmaar, the Netherlands

CORRESPONDENCE: W. Vincken, Respiratory Division, AZ VUB (Academic Hospital University of Brussels), 101 Laarbeeklaan, 1090, Brussels, Belgium. Fax: 32 2 4776019. E-mail: Walter.vincken@az.vub.ac.be

Keywords: chronic obstructive pulmonary disease, dyspnoea, exacerbations, ipratropium, quality of life, tiotropium.

Received: June 7, 2001
Accepted November 7, 2001

Tiotropium, a novel once-daily inhaled anticholinergic, has been shown to improve lung function over a 24-h period. In order to extend these findings, health-outcomes were evaluated over 1 yr in chronic obstructive pulmonary disease (COPD) patients.

Spirometric results, peak expiratory flow rate (PEFR), salbutamol use and effects on dyspnoea, health-related quality of life and COPD exacerbations were assessed in two identical 1-yr randomized double-blind double-dummy studies of tiotropium 18µg once daily (n=356) compared with ipratropium 40µg q.i.d. (n=179).

Screening forced expiratory volume in one second (FEV1) were 1.25±0.43 L (41.9±12.7% of the predicted value) (tiotropium) and 1.18±0.37 L (39.4±10.7% pred) (ipratropium). Trough FEV1 at 1 yr improved by 0.12±0.01 L with tiotropium and declined by 0.03±0.02 L with ipratropium (p<0.001). Significant improvement in PEFR, salbutamol use, Transition Dyspnea Index focal score, and the St George's Respiratory Questionnaire total and impact scores were seen with tiotropium (p<0.01). Tiotropium reduced the number of exacerbations (by 24%, p<0.01), and increased time to first exacerbation (p<0.01) and time to first hospitalization for a COPD exacerbation (p<0.05) compared with ipratropium. Apart from an increased incidence of dry mouth in the tiotropium group, adverse events were similar between treatments.

Tiotropium was effective in improving dyspnoea, exacerbations, health-related quality of life and lung function in patients with chronic obstructive pulmonary disease, and exceeds the benefits seen with ipratropium. The data support the use of tiotropium once-daily as first-line maintenance treatment in patients with chronic obstructive pulmonary disease.




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D.E. O'Donnell, T. Fluge, F. Gerken, A. Hamilton, K. Webb, B. Aguilaniu, B. Make, and H. Magnussen
Effects of tiotropium on lung hyperinflation, dyspnoea and exercise tolerance in COPD
Eur. Respir. J., June 1, 2004; 23(6): 832 - 840.
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B.R. Celli, W. MacNee, A. Agusti, A. Anzueto, B. Berg, A.S. Buist, P.M.A. Calverley, N. Chavannes, T. Dillard, B. Fahy, et al.
Standards for the diagnosis and treatment of patients with COPD: a summary of the ATS/ERS position paper
Eur. Respir. J., June 1, 2004; 23(6): 932 - 946.
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 ChestHome page
A. Hasani, N. Toms, J. E. Agnew, M. Sarno, A. J. Harrison, and P. Dilworth
The Effect of Inhaled Tiotropium Bromide on Lung Mucociliary Clearance in Patients With COPD
Chest, May 1, 2004; 125(5): 1726 - 1734.
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 ThoraxHome page
M Miravitlles, M Ferrer, A Pont, R Zalacain, J L Alvarez-Sala, F Masa, H Verea, C Murio, F Ros, and R Vidal
Effect of exacerbations on quality of life in patients with chronic obstructive pulmonary disease: a 2 year follow up study
Thorax, May 1, 2004; 59(5): 387 - 395.
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 Chronic Respiratory DiseaseHome page
J A Wedzicha
Short burst oxygen therapy is helpful?
Chronic Respiratory Disease, April 1, 2004; 1(2): 101 - 103.
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 Proc Am Thorac SocHome page
R. A. Pauwels
Similarities and Differences in Asthma and Chronic Obstructive Pulmonary Disease Exacerbations
Proceedings of the ATS, April 1, 2004; 1(2): 73 - 76.
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 Proc Am Thorac SocHome page
P. M. A. Calverley
Reducing the Frequency and Severity of Exacerbations of Chronic Obstructive Pulmonary Disease
Proceedings of the ATS, April 1, 2004; 1(2): 121 - 124.
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 JAMAHome page
R. G. Barr
Management of Chronic Obstructive Pulmonary Disease
JAMA, March 3, 2004; 291(9): 1066 - 1067.
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J.B. Oostenbrink, M.P.M.H. Rutten-van Molken, M.J. Al, J.A. Van Noord, and W. Vincken
One-year cost-effectiveness of tiotropium versus ipratropium to treat chronic obstructive pulmonary disease
Eur. Respir. J., February 1, 2004; 23(2): 241 - 249.
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 J Clin PharmacolHome page
D. Turck, W. Weber, R. Sigmund, K. Budde, H.-H. Neumayer, L. Fritsche, K.-L. Rominger, U. Feifel, and T. Slowinski
Pharmacokinetics of Intravenous, Single-Dose Tiotropium in Subjects with Different Degrees of Renal Impairment
J. Clin. Pharmacol., February 1, 2004; 44(2): 163 - 172.
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 ChestHome page
M. Cazzola and M. G. Matera
Long-Acting Bronchodilators Are the First-Choice Option for the Treatment of Stable COPD
Chest, January 1, 2004; 125(1): 9 - 11.
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D. P. Tashkin and C. B. Cooper
The Role of Long-Acting Bronchodilators in the Management of Stable COPD
Chest, January 1, 2004; 125(1): 249 - 259.
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G.C. Donaldson, T.A.R. Seemungal, I.S. Patel, S.J. Lloyd-Owen, T.M.A. Wilkinson, and J.A. Wedzicha
Longitudinal changes in the nature, severity and frequency of COPD exacerbations
Eur. Respir. J., December 1, 2003; 22(6): 931 - 936.
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N. K. Leidy, S. I. Rennard, J. Schmier, M. K. C. Jones, and M. Goldman
The Breathlessness, Cough, and Sputum Scale: The Development of Empirically Based Guidelines for Interpretation
Chest, December 1, 2003; 124(6): 2182 - 2191.
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B. R. Celli
A 62-Year-Old Woman With Chronic Obstructive Pulmonary Disease
JAMA, November 26, 2003; 290(20): 2721 - 2729.
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M. Decramer
Treatment of chronic respiratory failure: lung volume reduction surgery versus rehabilitation
Eur. Respir. J., November 16, 2003; 22(47_suppl): 47s - 56s.
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D. D. Sin, F. A. McAlister, S. F. P. Man, and N. R. Anthonisen
Contemporary Management of Chronic Obstructive Pulmonary Disease: Scientific Review
JAMA, November 5, 2003; 290(17): 2301 - 2312.
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 ChestHome page
B. Celli, R. ZuWallack, S. Wang, and S. Kesten
Improvement in Resting Inspiratory Capacity and Hyperinflation With Tiotropium in COPD Patients With Increased Static Lung Volumes
Chest, November 1, 2003; 124(5): 1743 - 1748.
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P J Barnes
Chronic obstructive pulmonary disease * 12: New treatments for COPD
Thorax, September 1, 2003; 58(9): 803 - 808.
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S.I. Rennard and P. Calverley
Rescue! Therapy and the paradox of the Barcalounger
Eur. Respir. J., June 1, 2003; 21(6): 916 - 917.
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S. Burge and J.A. Wedzicha
COPD exacerbations: definitions and classifications
Eur. Respir. J., June 1, 2003; 21(41_suppl): 46S - 53s.
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D. Tashkin and S. Kesten
Long-term Treatment Benefits With Tiotropium in COPD Patients With and Without Short-term Bronchodilator Responses
Chest, May 1, 2003; 123(5): 1441 - 1449.
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M R Partridge
Patients with COPD: do we fail them from beginning to end?
Thorax, May 1, 2003; 58(5): 373 - 375.
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