E. D. Bateman;D. Tashkin;N. Siafakas;R. Dahl;L. Towse;D. Massey;D. Pavia;南山 钟
University of Cape Town;University of California at Los Angeles;University of Crete;Aarhus University;Boehringer Ingelheim GmbH;Guangzhou Medical College
发表时间:2010-10
期 刊:Respiratory Medicine
语 言:English
U R L: http://www.scopus.com/inward/record.url?scp=77956338422&partnerID=8YFLogxK
In this randomised double-blind study, patients ≥40 years old with COPD, a smoking history of ≥10 pack-years, a pre-bronchodilator FEV1 of ≤60% predicted and an FEV1/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 FEV1 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 FEV1 was 1.11 L (0.40 L) or 40% (12%) of predicted normal. Adjusted mean differences in trough FEV1 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.
医学与生命科学
Scopus度量
年份 | CiteScore | SJR | SNIP |
---|---|---|---|
1996 | |||
1997 | |||
1998 | |||
1999 | 0.486 | 0.651 | |
2000 | 0.62 | 0.784 | |
2001 | 0.816 | 0.815 | |
2002 | 0.809 | 0.807 | |
2003 | 0.838 | 0.948 | |
2004 | 0.677 | 0.946 | |
2005 | 0.776 | 0.975 | |
2006 | 1.028 | 0.992 | |
2007 | 1.129 | 1.032 | |
2008 | 1.172 | 0.997 | |
2009 | 1.142 | 1.07 | |
2010 | 1.116 | 1.172 | |
2011 | 5.2 | 1.397 | 1.405 |
2012 | 5.6 | 1.34 | 1.282 |
2013 | 6 | 1.492 | 1.513 |
2014 | 6.4 | 1.389 | 1.403 |
2015 | 6.8 | 1.483 | 1.47 |
2016 | 6.5 | 1.527 | 1.381 |
2017 | 5.9 | 1.472 | 1.217 |
2018 | 5.4 | 1.456 | 1.269 |
2019 | 5.5 | 1.25 | 1.287 |
2020 | 5.4 | ||
2021 |
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