| Title : Efficacy and safety of tiotropium Respimat SMI in COPD in two 1-year randomized studies - Bateman_2010_Int.J.Chron.Obstruct.Pulmon.Dis_5_197 |
| Author(s) : Bateman E , Singh D , Smith D , Disse B , Towse L , Massey D , Blatchford J , Pavia D , Hodder R |
| Ref : Int J Chron Obstruct Pulmon Dis , 5 :197 , 2010 |
| Abstract : Two 1-year studies evaluated the long-term efficacy and safety of tiotropium 5 or 10 microg versus placebo, inhaled via the Respimat Soft Mist Inhaler (SMI). The two studies were combined and had 4 co-primary endpoints (trough FEV(1) 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 FEV(1): 1.09 L). The mean trough FEV(1) response of tiotropium 5 or 10 microg relative to placebo was 127 or 150 mL, respectively (both P < 0.0001). The COPD exacerbation rate was significantly lower with tiotropium 5 microg (RR = 0.78; P = 0.002) and tiotropium 10 microg (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 microg), 2.7% (10 microg), and 1.6% (placebo) of patients; these differences were not significant. Tiotropium Respimat SMI 5 microg demonstrated sustained improvements in patients with COPD relative to placebo and similar to the 10 microg dose but with a lower frequency of anticholinergic adverse events. |
| ESTHER : Bateman_2010_Int.J.Chron.Obstruct.Pulmon.Dis_5_197 |
| PubMedSearch : Bateman_2010_Int.J.Chron.Obstruct.Pulmon.Dis_5_197 |
| PubMedID: 20714373 |
Bateman E, Singh D, Smith D, Disse B, Towse L, Massey D, Blatchford J, Pavia D, Hodder R (2010)
Efficacy and safety of tiotropium Respimat SMI in COPD in two 1-year randomized studies
Int J Chron Obstruct Pulmon Dis
5 :197
Bateman E, Singh D, Smith D, Disse B, Towse L, Massey D, Blatchford J, Pavia D, Hodder R (2010)
Int J Chron Obstruct Pulmon Dis
5 :197