Tiotropium versus placebo for chronic obstructive pulmonary disease

Karner, Charlotta; Chong, Jimmy; Poole, Phillippa

doi:10.1002/14651858.cd009285.pub3

Cited by 150 publications

(78 citation statements)

References 94 publications

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“…Both the Cochrane [4] and Thorax [5] meta-analyses have reported no effect of tiotropium HandiHaler on mortality risk, and a significant difference in mortality risk between the HandiHaler and Respimat inhalers. It has been suggested that this difference may weaken the evidence of mortality risk with tiotropium Respimat [12].…”

Section: Differential Risk With Tiotropium Productsmentioning

confidence: 99%

“…The overall estimates were not substantially changed by sensitivity analyses using the random effects model, limiting the analysis to three trials of 1-year duration period each, or the inclusion of additional preliminary data on tiotropium Respimat from an unpublished study. An accompanying editorial calculated, based on these figures, that one excess death is expected for every 121 (COPD) patients treated with a 5 mg dose of tiotropium by Respimat for 12 months [11].The 2012 Cochrane Review of tiotropium included the same five randomised placebo-controlled clinical trials of tiotropium Respimat, but used the Peto method for pooled estimation of odds ratio, which is arguably more appropriate for the combined analysis of rare events such as death [4]. Tiotropium Respimat significantly increased the risk of mortality, OR 1.47 (95% CI 1.04-2.08).…”

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confidence: 99%

“…Tiotropium Respimat should not be prescribed in COPD http://ow.ly/mzPGL Systematic reviews and meta-analyses of randomised controlled trials of medications provide a high standard of evidence to inform clinical practice, and can be considered the ''gold standard'' for assessing the risk/benefit profile of treatments [1,2]. Three systematic reviews and meta-analyses (including a Cochrane Review) of randomised placebo-controlled trials of tiotropium Respimat, each using different methods, have demonstrated a 50% increased risk of mortality, with its use in patients with chronic obstructive pulmonary disease (COPD) [3][4][5]. These analyses provide substantive evidence that tiotropium Respimat increases mortality in the treatment of COPD [6,7].…”

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confidence: 99%

“…The 2012 Cochrane Review of tiotropium included the same five randomised placebo-controlled clinical trials of tiotropium Respimat, but used the Peto method for pooled estimation of odds ratio, which is arguably more appropriate for the combined analysis of rare events such as death [4]. Tiotropium Respimat significantly increased the risk of mortality, OR 1.47 (95% CI 1.04-2.08).…”

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Tiotropium Respimat increases the risk of mortality: pro

Beasley

2013

Eur Respir J

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@ERSpublications Tiotropium Respimat increases mortality risk. First do no harm. Tiotropium Respimat should not be prescribed in COPD http://ow.ly/mzPGL Systematic reviews and meta-analyses of randomised controlled trials of medications provide a high standard of evidence to inform clinical practice, and can be considered the ''gold standard'' for assessing the risk/benefit profile of treatments [1,2]. Three systematic reviews and meta-analyses (including a Cochrane Review) of randomised placebo-controlled trials of tiotropium Respimat, each using different methods, have demonstrated a 50% increased risk of mortality, with its use in patients with chronic obstructive pulmonary disease (COPD) [3][4][5]. These analyses provide substantive evidence that tiotropium Respimat increases mortality in the treatment of COPD [6,7]. It is informative to review each of the systematic reviews and the issues that have been raised relevant to their interpretation.In 2011 the British Medical Journal (BMJ) published the first systematic review and meta-analysis, which included all parallel-group, randomised, placebo-controlled trials of tiotropium Respimat in the treatment of COPD that had reported data on mortality and were of a minimum 30-day duration [3] (table 1 [ [8][9][10]). Five trials were included in the analysis, two 12-week trials and three 12-month trials, studying 6522 participants. All five trials were judged to be at low risk of bias. Tiotropium Respimat significantly increased the risk of all-cause mortality, relative risk 1.52 (95% CI 1.06-2.16). There was an apparent dose-response effect on all-cause mortality, with RR 1.46 (95% CI 1.01-2.10) and 2.15 (95% CI 1.03-4.51), for the 5-mg and 10-mg preparations, respectively ( fig. 1). The overall estimates were not substantially changed by sensitivity analyses using the random effects model, limiting the analysis to three trials of 1-year duration period each, or the inclusion of additional preliminary data on tiotropium Respimat from an unpublished study. An accompanying editorial calculated, based on these figures, that one excess death is expected for every 121 (COPD) patients treated with a 5 mg dose of tiotropium by Respimat for 12 months [11].The 2012 Cochrane Review of tiotropium included the same five randomised placebo-controlled clinical trials of tiotropium Respimat, but used the Peto method for pooled estimation of odds ratio, which is arguably more appropriate for the combined analysis of rare events such as death [4]. Tiotropium Respimat significantly increased the risk of mortality, OR 1.47 (95% CI 1.04-2.08). In contrast there was no increased risk of mortality with tiotropium HandiHaler, OR 0.92 (95% CI 0.80-1.05).In 2012 Thorax published a systematic review with direct comparison and mixed treatment comparison meta-analyses of randomised controlled trials of medications used in the treatment of COPD that provided data about overall or cardiovascular death, and were a minimum 6 months in trial duration [5]. In the direct comparison meta-analysis, ti...

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Section: Differential Risk With Tiotropium Productsmentioning

confidence: 99%

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confidence: 99%

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confidence: 99%

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Tiotropium Respimat increases the risk of mortality: pro

Beasley

2013

Eur Respir J

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“…It has been revealed in many studies that inhaled tiotropium is effective in improving lung functions and the quality of life in patients with COPD compared with a placebo (15). Moreover, according to the results of many studies, tiotropium shows an equivalent effect with long-acting β 2 agonists in many parameters, such as the rates of hospitalization and pulmonary functions and the improvement of symptoms in COPD treatment (16).…”

Section: Discussionmentioning

confidence: 99%

The Effects of Budesonid That Added to Tiotropium Therapy on Health Related Quality of Life, Exercise Capacity and Pulmonary Functions in COPD Patients

Arslan¹,

Turgut²

2015

Eurasian J Pulmonol

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Objective: The aim of this study was to evaluate the effects of adding inhaled budesonide to the tiotropium treatment on the pulmonary function tests, health-related quality of life and exercise capacity of patients with chronic obstructive pulmonary disease (COPD). Methods:Forty study subjects with COPD were randomized to two groups. The patients in the first group was treated with 1x1 18 mcg of Tiotropium and the patients in the second group was treated with the combination of tiotropium (18 mcg 1x1) and budesonide (400 mcg 2x1) for three months. Pulmonary function tests, six minute walk test, body mass index and Saint George Respiratory Questionnaire (SGRQ) scores were recorded both at the beginning and 3 months later and the results at the begining and third month were compared with each other. There were no statistically significant difference in all basline parameters between the two groups. Results:At the end of the study, no statistically significant differences were obtained between two groups in terms of pulmonary function tests (p>0.05). Significant improvements were observed on the parameters of walking distance (p=0.023) and SGRQ scores (symptom score: p<0.001, activity score: p=0.001, impact score: p=0.003 and total score: p<0.001) in Group 2 when compared with Group 1. Conclusion:These results show that, in patients with COPD, tiotropium/budesonide combination is more effective than alone tiotropium inhalation in quality of life and exercise performance. But this combination is not more effective in improving lung functions.

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