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Tiotropium for stable chronic obstructive pulmonary disease: A meta-analysis.

ABSTRACT: A systematic review was undertaken to evaluate the efficacy of tiotropium, a long acting anticholinergic drug, on clinical events, symptom scales, pulmonary function, and adverse events in stable chronic obstructive pulmonary disease (COPD).A systematic search was made of the Cochrane trials database, MEDLINE, EMBASE, CINAHL, and a hand search of 20 respiratory journals. Missing data were obtained from authors and the manufacturer. Randomised controlled trials of > or =12 weeks' duration comparing tiotropium with placebo, ipratropium bromide, or long acting beta2 agonists (LABA) were reviewed. Studies were pooled to yield odds ratios (OR) or weighted mean differences with 95% confidence intervals (CI).Nine trials (8002 patients) met the inclusion criteria. Tiotropium reduced the odds of a COPD exacerbation (OR 0.73; 95% CI 0.66 to 0.81) and related hospitalisation (OR 0.68; 95% CI 0.54 to 0.84) but not pulmonary (OR 0.50; 95% CI 0.19 to 1.29) or all-cause (OR 0.96; 95% CI 0.63 to 1.47) mortality compared with placebo and ipratropium. Reductions in exacerbations and hospitalisations compared with LABA were not statistically significant. Similar patterns were evident for quality of life and symptom scales. Tiotropium yielded greater increases in forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) from baseline to 6-12 months than did placebo, ipratropium, and LABA. Decline in FEV1 over 1 year was 30 ml (95% CI 7 to 53) slower with tiotropium than with placebo and ipratropium (data were not available for LABA). Reports of dry mouth and urinary tract infections were increased with tiotropium.Tiotropium reduced COPD exacerbations and related hospitalisations, improved quality of life and symptoms, and may have slowed the decline in FEV1. Long term trials are warranted to evaluate the effects of tiotropium on decline in FEV1 and to clarify its role compared with LABA.

SUBMITTER: Barr RG

PROVIDER: S-EPMC2104759 | biostudies-literature | 2006 Oct

REPOSITORIES: biostudies-literature

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Tiotropium for stable chronic obstructive pulmonary disease: A meta-analysis.

Barr R G RG Bourbeau J J Camargo C A CA Ram F S F FS

Thorax 20060714 10

<h4>Background</h4>A systematic review was undertaken to evaluate the efficacy of tiotropium, a long acting anticholinergic drug, on clinical events, symptom scales, pulmonary function, and adverse events in stable chronic obstructive pulmonary disease (COPD).<h4>Methods</h4>A systematic search was made of the Cochrane trials database, MEDLINE, EMBASE, CINAHL, and a hand search of 20 respiratory journals. Missing data were obtained from authors and the manufacturer. Randomised controlled trials ...[more]

PMID: 16844726

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Project description:BACKGROUND:To investigate the effectiveness of Liuzijue exercise on chronic obstructive pulmonary disease (COPD) in the stable phase. METHODS:We searched six electronic bibliographic databases (PubMed, EMBASE, The Cochrane Library, Web of Science, CNKI, and Wan Fang Data) from inception to August 2018. Randomized controlled trials (RCTs) were included if they evaluated the effect of Liuzijue exercise on stable COPD. Cochrane Collaboration risk-of-bias tool (Cochrane Handbook 5.1.0) was used to assess the risk of bias of included RCTs. Meta-analysis was performed using the Review Manager software (RevMan V.5.3.5) provided by the Cochrane Collaboration. Outcomes assessed included dyspnea, exercise capacity, lung function, and quality of life. RESULTS:Fourteen RCTs involving 920 stable COPD patients were included in this systematic review and meta-analysis. The control groups received usual care. The average number of training sessions per participant was 9.3 per week, and the average length of these training sessions was 31.6?min per week. Training duration varied from 3 to 12?months. Meta-analysis results showed that Liuzijue exercise can effectively improve patients' Modified Medical Research Council Dyspnea Scale scores (MD?=?-?0.73, 95% CI: -?1.13 to -?0.33, P?<?0.05), 6MWD (MD?=?17.78, 95% CI: 7.97 to 27.58, P?<?0.05), forced expiratory volume in one second (FEV1) (MD?=?0.23, 95% CI: 0.07 to 0.38, P?<?0.05), the percentage of predicted values of FEV1 (FEV1%pred) (MD?=?7.59, 95% CI: 2.92 to 12.26, P?<?0.05), FEV1/FVC (Forced vital capacity) ratio (MD?=?6.81, 95% CI: 3.22 to 10.40, P?<?0.05), Quality of life: St. George's Respiratory Questionnaire total score (MD?=?-?9.85, 95%CI: -?13.13 to -?6.56, P?<?0.05), and Chronic Obstructive Pulmonary Disease Assessment Test score (MD?=?-?2.29, 95%CI: -?3.27, -?1.30, P?< 0.05). CONCLUSION:Evidence from meta-analysis suggested that Liuzijue exercise could improve dyspnea, exercise endurance, lung function, and quality of life for stable COPD patients. However, owing to the methodological bias and the placebo effect of Liuzijue exercise, there is a need for further research to confirm these findings. TRIAL REGISTRATION:PROSPERO (ID: CRD42019130973 ).

Project description:ObjectiveTo systematically review the risk of mortality associated with long term use of tiotropium delivered using a mist inhaler for symptomatic improvement in chronic obstructive pulmonary disease.Data sourcesMedline, Embase, the pharmaceutical company clinical trials register, the US Food and Drug Administration website, and ClinicalTrials.gov for randomised controlled trials from inception to July 2010.Study selectionTrials were selected for inclusion if they were parallel group randomised controlled trials of tiotropium solution using a mist inhaler (Respimat Soft Mist Inhaler, Boehringer Ingelheim) versus placebo for chronic obstructive pulmonary disease; the treatment duration was more than 30 days, and they reported data on mortality. Relative risks of all cause mortality were estimated using a fixed effect meta-analysis, and heterogeneity was assessed with the I(2) statistic.ResultsFive randomised controlled trials were eligible for inclusion. Tiotropium mist inhaler was associated with a significantly increased risk of mortality (90/3686 v 47/2836; relative risk 1.52, 95% confidence interval, 1.06 to 2.16; P = 0.02; I(2) = 0%). Both 10 µg (2.15, 1.03 to 4.51; P = 0.04; I(2) = 9%) and 5 µg (1.46, 1.01 to 2.10; P = 0.04; I(2) = 0%) doses of tiotropium mist inhaler were associated with an increased risk of mortality. The overall estimates were not substantially changed by sensitivity analysis of the fixed effect analysis of the five trials combined using the random effects model (1.45, 1.02 to 2.07; P = 0.04), limiting the analysis to three trials of one year's duration each (1.50, 1.05 to 2.15), or the inclusion of additional data on tiotropium mist inhaler from another investigational drug programme (1.42, 1.01 to 2.00). The number needed to treat for a year with the 5 µg dose to see one additional death was estimated to be 124 (95% confidence interval 52 to 5682) based on the average control event rate from the long term trials.ConclusionsThis meta-analysis explains safety concerns by regulatory agencies and indicates a 52% increased risk of mortality associated with tiotropium mist inhaler in patients with chronic obstructive pulmonary disease.

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Tiotropium for stable chronic obstructive pulmonary disease: A meta-analysis.

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Tiotropium for stable chronic obstructive pulmonary disease: A meta-analysis.

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