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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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