Efficacy and safety of tiotropium Respimat^® SMI in COPD in two 1-year randomized studies

Original Research

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Authors: Eric Bateman, Dave Singh, David Smith, et al

Published Date June 2010 Volume 2010:5 Pages 197 - 208

DOI: http://dx.doi.org/10.2147/COPD.S9616

Eric Bateman¹, Dave Singh², David Smith³, Bernd Disse⁴, Lesley Towse⁵, Dan Massey⁵, Jon Blatchford⁵, Demetri Pavia⁵, Rick Hodder⁶

¹Division of Pulmonology, Department of Medicine, University of Cape Town, Cape Town, South Africa; ²University Hospital of South Manchester Foundation Trust, University of Manchester, Manchester, UK; ³North Bristol Lung Centre, Southmead Hospital, Bristol, UK; ⁴Boehringer Ingelheim, GmbH, Ingelheim, Germany; ⁵Boehringer Ingelheim, Ltd., Bracknell, Berkshire, UK; ⁶Divisions of Pulmonary and Critical Care Medicine, University of Ottawa, Ottawa, Ontario, Canada

Abstract: Two 1-year studies evaluated the long-term efficacy and safety of tiotropium 5 or 10 μg versus placebo, inhaled via the Respimat^® Soft Mist^TM Inhaler (SMI). The two studies were combined and had 4 co-primary endpoints (trough FEV₁ response, Mahler Transition Dyspnea Index [TDI] and St George’s Respiratory Questionnaire scores all at week 48, and COPD exacerbations per patient-year). A total of 1990 patients with COPD participated (mean FEV₁: 1.09 L). The mean trough FEV₁ response of tiotropium 5 or 10 μg relative to placebo was 127 or 150 mL, respectively (both P < 0.0001). The COPD exacerbation rate was significantly lower with tiotropium 5 μg (RR = 0.78; P = 0.002) and tiotropium 10 μg (RR = 0.73; P = 0.0008); the health-related quality of life and Mahler TDI co-primary endpoints were significantly improved with both doses (both P < 0.0001). Adverse events were generally balanced except anticholinergic class effects, which were more frequent with active treatment. Fatal events occurred in 2.4% (5 μg), 2.7% (10 μg), and 1.6% (placebo) of patients; these differences were not significant. Tiotropium Respimat^® SMI 5 μg demonstrated sustained improvements in patients with COPD relative to placebo and similar to the 10 μg dose but with a lower frequency of anticholinergic adverse events.

Keywords: COPD, exacerbations, FEV₁, quality of life, Respimat^®, tiotropium

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