2014
DOI: 10.1097/01.sa.0000443073.86006.ef
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Tiotropium Respimat Inhaler and the Risk of Death in COPD

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Cited by 57 publications
(76 citation statements)
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“…Tiotropium via Respimat (5 lg once daily) improved lung function, health-related quality of life, decreased COPD exacerbations, and was at least as effective as tiotropium via HandiHaler [10,11]. The TIOtropium Safety and Performance In Respimat (TIOSPIR TM ) study demonstrated that tiotropium via Respimat (5 lg once daily) was not inferior to tiotropium via HandiHaler in terms of all-cause mortality, and the risk of cardiovascular mortality or major adverse cardiovascular events did not significantly differ between the two treatment periods [12]. Respimat is now an option among the various inhalation devices and is available world-wide, including Japan, for the treatment of COPD.…”
Section: Introductionmentioning
confidence: 99%
“…Tiotropium via Respimat (5 lg once daily) improved lung function, health-related quality of life, decreased COPD exacerbations, and was at least as effective as tiotropium via HandiHaler [10,11]. The TIOtropium Safety and Performance In Respimat (TIOSPIR TM ) study demonstrated that tiotropium via Respimat (5 lg once daily) was not inferior to tiotropium via HandiHaler in terms of all-cause mortality, and the risk of cardiovascular mortality or major adverse cardiovascular events did not significantly differ between the two treatment periods [12]. Respimat is now an option among the various inhalation devices and is available world-wide, including Japan, for the treatment of COPD.…”
Section: Introductionmentioning
confidence: 99%
“…Надежные данные о безопасности препарата Спирива Респимат получены в крупнейшем на се годня исследовании TIOSPIR (The Tiotropium Safety and Performance in Respimat Trial) [68]. На протяжении в среднем 2,3 года больные ХОБЛ (n = 17 135) при нимали препарат Спирива Респимат в дозах 2,5 или 5 мкг в сутки или Спирива ХандиХалер в дозе 18 мкг в сутки.…”
Section: длительная домашняя вентиляция легких (ддвл)unclassified
“…In fact, the problem was not that the tiotropium treated patients were dying too frequently (their mortality rate was in line with many similar study populations) but that the death rate in placebo-treated patients was unusually low. Once raised, such concerns are not easily allayed and it was not until over 17,000 patients were recruited to the TIOSPIR study that the soft mist system was shown to be safe 35 .…”
Section: Study Design Biasmentioning
confidence: 99%
“…One way to avoid these problems is to simplify the trial protocol as much as possible and focus on your primary outcome. Thus, both the Prevention of Exacerbations with Tiotropium (POET) (7,000 subjects) and the event-driven Tiotropium Safety and Performance in Respimat (TIOSPIR) studies (17,135 subjects) did not monitor spirometry regularly and had relatively simple designs focussed on the primary outcome (exacerbations and mortality respectively) 12,13 . Happily, both gave rise to a clear result.…”
Section: Barcelona Respiratory Networkmentioning
confidence: 99%