Tiotropium improves FEV₁ in patients with COPD irrespective of smoking status

详细信息    查看全文

• 作者：J. Moita ; C. Bá ; rbara ; J. Cardoso ; R. Costa ; M. Sousa ; J. Ruiz ; M.L. Santos
• 关键词：Tiotropium ; Lung function ; FEV₁ ; Smoking status ; COPD
• 刊名：Pulmonary Pharmacology & Therapeutics
• 出版年：2008
• 出版时间：February 2008
• 年：2008
• 卷：21
• 期：1
• 页码：146-151
• 全文大小：158 K

文摘

This study evaluated whether the effect of tiotropium on the change in trough forced expiratory volume in 1 s (FEV₁), vs. placebo, is affected by smoking status. In a 3-month, double-blind study in 31 centres in Portugal, 311 (289 completed) patients were randomised to tiotropium 18 μg once daily or placebo. Baseline mean (standard deviation (SD)) FEV₁ was 1.11 (0.39) l in the tiotropium group and 1.13 (0.39) l in the placebo group. Patients had an average smoking history of 55 (25.7) pack-years; 80 (26 % ) were smokers and 224 (74 % ) were ex-smokers. The primary end-point was change in morning pre-dose (i.e. trough) FEV₁ after 12 weeks. Trough FEV₁ at 12 weeks was significantly improved with tiotropium vs. placebo: the difference in means was 102 ml, P=0.0011, 95 % confidence interval (CI) (41, 164). The difference in means in smokers was 138 ml, P=0.0105, CI (32, 244); in ex-smokers it was 66 ml, P=0.0375, CI (3, 129). The difference between smokers and ex-smokers was not statistically significant (P=0.6982) and may be due to greater variability and differences in disease severity. The significant improvement in lung function in patients treated with tiotropium vs. placebo in both smokers and ex-smokers suggests that tiotropium is an effective and well-tolerated therapy in chronic obstructive pulmonary disease (COPD), regardless of smoking status.