A one-year trial of tiotropium Respimat ® plus usual therapy in COPD patients

In this randomised double-blind study, patients ≥40 years old with COPD, a smoking history of ≥10 pack-years, a pre-bronchodilator FEV 1 of ≤60% predicted and an FEV 1/FVC of ≤70% received tiotropium 5 μg or placebo via Respimat ® inhaler once daily for 48 weeks. Other medications were permitted exc...

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Vydané v:	Respiratory medicine Ročník 104; číslo 10; s. 1460 - 1472
Hlavní autori:	Bateman, E.D., Tashkin, D., Siafakas, N., Dahl, R., Towse, L., Massey, D., Pavia, D., Zhong, N.S.
Médium:	Journal Article
Jazyk:	English
Vydavateľské údaje:	Kidlington Elsevier Ltd 01.10.2010 Elsevier Elsevier Limited
Predmet:	Aged Biological and medical sciences Bronchodilator Agents - administration & dosage Bronchodilator Agents - adverse effects Chronic obstructive pulmonary disease, asthma Clinical trials COPD Disease Progression Double-Blind Method Drug therapy Exacerbation Female Forced Expiratory Volume - drug effects Forced Expiratory Volume - physiology Humans Male Medical sciences Patient Compliance Pharmaceutical industry Pneumology Pulmonary Disease, Chronic Obstructive - drug therapy Pulmonary Disease, Chronic Obstructive - mortality Pulmonary Disease, Chronic Obstructive - physiopathology Pulmonary/Respiratory Quality of life Respiratory Function Tests Scopolamine Derivatives - administration & dosage Scopolamine Derivatives - adverse effects Smoking - physiopathology Spirometry Tiotropium Tiotropium Bromide Exacerbation Spirometry Tiotropium COPD Human Lung disease Respiratory disease Tiotropium bromide Exploration Chronic Lung function Treatment Bronchus disease Chronic obstructive pulmonary disease Obstructive pulmonary disease Pneumology
ISSN:	0954-6111, 1532-3064, 1532-3064
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Shrnutí:	In this randomised double-blind study, patients ≥40 years old with COPD, a smoking history of ≥10 pack-years, a pre-bronchodilator FEV 1 of ≤60% predicted and an FEV 1/FVC of ≤70% received tiotropium 5 μg or placebo via Respimat ® inhaler once daily for 48 weeks. Other medications were permitted except inhaled anticholinergics. Co-primary endpoints were trough FEV 1 and the time to first exacerbation. Adverse events were followed and vital status regularly assessed. In all, 3991 patients (mean age, 65 years [SD, 9 years]) were evaluable. Mean baseline FEV 1 was 1.11 L (0.40 L) or 40% (12%) of predicted normal. Adjusted mean differences in trough FEV 1 and trough FVC at Week 48 (tiotropium minus placebo) were 102 and 168 ml respectively ( p < 0.0001, both). Tiotropium delayed time to first exacerbation relative to placebo (hazard ratio [HR], 0.69 [95% CI, 0.63–0.77]) and time to first hospital-treated exacerbation (HR, 0.73 [0.59–0.90]). SGRQ score at Week 48 was 2.9 units lower with tiotropium ( p < 0.0001). Adverse and serious adverse events were balanced across treatment groups and similar in profile to previous tiotropium trials. The rate ratio for a major adverse cardiovascular event during the treatment period + 30 days was 1.12 (0.67–1.86). By the end of planned treatment (Day 337) 52 patients on tiotropium (incidence rate per 100 years, 2.94) and 38 on placebo (2.13) had died (HR = 1.38 [0.91–2.10]; p = 0.13). Lung function, exacerbations and quality of life were improved by tiotropium 5 μg Respimat ® but a numerical imbalance was seen in all-cause mortality. The protocol is registered on the European Clinical Trials Database as trial number 2006-001009-27 and in the ClinicalTrials.gov database as NCT00387088.
Bibliografia:	ObjectType-Article-2 SourceType-Scholarly Journals-1 content type line 14 ObjectType-Undefined-1 ObjectType-Feature-3 ObjectType-Article-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3 ObjectType-Feature-1
ISSN:	0954-6111 1532-3064 1532-3064
DOI:	10.1016/j.rmed.2010.06.004