Brian J. Lipworth, MD
In patients with chronic obstructive pulmonary disease (COPD), does tiotropium delivered by mist inhaler increase mortality?
Included studies compared tiotropium mist inhaler (Respimat Soft Mist Inhaler, Boehringer Ingelheim) with placebo for treatment of COPD, had ≥ 30 days of treatment, and provided mortality data. Outcomes were all-cause and cardiovascular (death due to myocardial infarction or stroke, cardiac death, and sudden death) mortality.
MEDLINE, EMBASE/Excerpta Medica, Boehringer Ingelheim clinical trials register, US Food and Drug Administration Web site, ClinicalTrials.gov (all to Jul 2010), and reference lists were searched for parallel-group, randomized controlled trials (RCTs). 5 RCTs (n = 6522, mean age 65 y, 76% men), all from the same investigational program, met the selection criteria. All trials were double-blind and had adequate allocation concealment. Follow-up duration was 12 weeks for 2 RCTs and 1 year for 3 RCTs. 2839 patients received tiotropium, 5 µg, and 847 received tiotropium, 10 µg.
Meta-analysis showed that tiotropium mist inhaler increased all-cause mortality and cardiovascular mortality compared with placebo (Table).
In patients with chronic obstructive pulmonary disease, tiotropium delivered by mist inhaler increases mortality.
*Abbreviations defined in Glossary. Weighted event rates, RRI, NNH, and CI calculated from risk ratios and control event rates in article using a fixed-effect model.
†Death from myocardial infarction or stroke, cardiac death, and sudden death.
Lipworth BJ. Review: Tiotropium mist inhaler increases mortality in chronic obstructive pulmonary disease. Ann Intern Med. 2011;155:JC4–6. doi: 10.7326/0003-4819-155-8-201110180-02006
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Published: Ann Intern Med. 2011;155(8):JC4-6.
Chronic Obstructive Airway Disease, Pulmonary/Critical Care.
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