Tiotropium improves FEV1 in patients with COPD irrespective of smoking status

Abstract

This study evaluated whether the effect of tiotropium on the change in trough forced expiratory volume in 1 s (FEV 1 ), 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 mg once daily or placebo. Baseline mean (standard deviation (SD)) FEV 1 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) FEV 1 after 12 weeks. Trough FEV 1 at 12 weeks was significantly improved with tiotropium vs. placebo: the difference in means was 102 ml, P ¼ 0.0011, 95% confidence interval (CI) (41, 164). The difference in means in smokers was 138 ml, P ¼ 0.0105, CI (32, 244); in ex-smokers it was 66 ml, P ¼ 0.0375, CI (3, 129). The difference between smokers and ex-smokers was not statistically significant (P ¼ 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. r

Long-term efficacy of tiotropium in relation to smoking status in the UPLIFT trial

“…Conversely, tiotropium was associated with consistently significant improvements in lung function compared to the control arm over the course of the 4-yr study in all smoking behaviour categories, except for a more modest and nonsignificant improvement in post-bronchodilator FEV1 in the intermittent smokers at 4 yrs. Interestingly, consistent with the earlier findings of MOITA et al [1], the tiotropium-related improvement FEV1 was numerically greater in the continuing smokers than the ex-smokers at trough and even more so when examined after the administration of study drug and four inhalations of albuterol and ipratropium (table 3). However, the results of the study by MOITA et al [1] may not necessarily be comparable with the results of the UPLIFT trials due to possible differences in the proportion of subjects using concomitant medications in the two studies.…”

“…The sparse publications that have addressed this issue are mainly limited to short-term, 3-month studies involving anticholinergic bronchodilators and have yielded somewhat conflicting findings, as described above [1,2]; one of these studies showed a substantially, although not significantly, greater numerical response to tiotropium in trough FEV1 in continuing smokers than ex-smokers [1], while the other showed a more marked trough FEV1 response to ipratropium in ex-smokers than current smokers [2].…”

“…When comparing the efficacy of the long-acting anticholinergic bronchodilator, tiotropium, in a 3-month study between 80 smokers and 224 ex-smokers with chronic obstructive pulmonary disease (COPD), MOITA et al [1] previously reported twice as large a placeboadjusted improvement in pre-bronchodilator forced expired volume in 1 s (FEV1) in the smokers (138 mL) than the ex-smokers (66 mL), although the difference in the response to tiotropium between the two smoking groups was not statistically significant. In contrast, in a pooled analysis, stratified by smoking status, of seven clinical trials in which the short-acting anticholinergic bronchodilator, ipratropium, was compared with a b 2 -agonist over a 90-day treatment period in a total of 1,836 subjects with moderately severe COPD, the improvement in baseline lung function in the ipratropium-treated patients was found to be more marked in ex-smokers than current smokers [2].…”

The importance of dyspnoea in the diagnosis of chronic obstructive pulmonary disease – a descriptive analysis of a stable cohort in Portugal (SAFE Trial)

“…This trial was a prospective, multicentre, randomized, double-blind, placebo-controlled parallel-group study designed to determine whether the effect on lung function of inhaled tiotropium 18 g once daily over 12 weeks was affected by smoking status, 4 where thirty-one Portuguese respiratory centres participated. The trial was approved by each local ethics committee and institutional review board.…”

Consensus report: indications for use of long-acting antimuscarinic tiotropium in the treatment of bronchial asthma

“…Тиотропий обладает обширной доказательной базой в лечении больных ХОБЛ. Тиотропий оказывает количественно боль шее влияние на показатели спирометрии у курящих больных ХОБЛ, чем у бывших курильщиков [33]. В случае БА ипратропий также оказался более эф фективным именно у курящих пациентов [34].…”