Evidence map›Paper›PMID 21428765›Full record

Trial reportThe New England journal of medicine2011

Tiotropium versus salmeterol for the prevention of exacerbations of COPD.

Claus Vogelmeier, Bettina Hederer, Thomas Glaab, Hendrik Schmidt, Maureen P M H Rutten-van Mölken, Kai M Beeh, Klaus F Rabe, Leonardo M Fabbri, POET-COPD Investigators

3 registry-linked trialsOpen access · bronzeAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 241 papers, 16 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
241citing papers in PubMed, 16 pooled it
58.1field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00563381 phase4completednot on this map

Effect of Inhalation of Tiotropium Once Daily 18 Mcg Versus Salmeterol Twice Daily 50 Mcg on Time to First Exacerbation in COPD Patients (a Randomised, Double-blind, Double-dummy, Parallel Group, One-year Study).

TypeinterventionalSponsorBoehringer IngelheimRan2008Enrolled7,376ConditionsPulmonary Disease, Chronic ObstructiveArmsTiotropium bromide, Salmeterol, Placebo Salmeterol, Placebo Tiotropium
NCT04061161 phase4completednot on this mapstarted 2019, after this paper: background citation

Anti-inflammatory Effects of Tiotropium in Patients with Stable COPD- a Multicenter Randomized Controlled Double-blind Study

TypeinterventionalSponsorUniversity Medical Center GroningenRan2019 to 2023Enrolled37ConditionsCOPDArmsTiotropium Bromide
NCT05506865 phase4completednot on this mapstarted 2012, after this paper: background citation

Efficacy and Safety of Indacaterol vs Tiotropium From Baseline to 24 Weeks, in Women With Moderate-severe COPD Secondary to Biomass Exposure: Randomized, Non Inferior, Open Label, Parallel Groups Clinical Trial

TypeinterventionalSponsorNational Institute of Respiratory Diseases, MexicoRan2012 to 2016Enrolled73ConditionsCOPDArmsIndacaterol, Tiotropium
3 · Its place in the literature

Who cites it

241 citing papers in PubMed, 16 syntheses or guidelines pooled it, 679 citations in OpenAlex.

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  5. Risks of budesonide/formoterol for the treatment of stable COPD: a meta-analysis.International journal of chronic obstructive pulmonary disease · 2019
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  9. Treatment of lung disease in alpha-1 antitrypsin deficiency: a systematic review.International journal of chronic obstructive pulmonary disease · 2017
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181 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 5 institutions in 4 countries.

Claus VogelmeierHospital of the Universities of Giessen and Marburg, Marburg, Germany.
Bettina Hederer
Thomas Glaab
Hendrik Schmidt
Maureen P M H Rutten-van Mölken
Kai M Beeh
Klaus F Rabe
Leonardo M Fabbri
POET-COPD Investigators
Boehringer Ingelheim (Egypt) · EGLeiden University Medical Center · NLRespiratory Research Institute · DEUniversitätsklinikum Gießen und Marburg · DEUniversity of Modena and Reggio Emilia · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTreatment guidelines recommend the use of inhaled long-acting bronchodilators to alleviate symptoms and reduce the risk of exacerbations in patients with moderate-to-very-severe chronic obstructive pulmonary disease (COPD) but do not specify whether a long-acting anticholinergic drug or a β(2)-agonist is the preferred agent. We investigated whether the anticholinergic drug tiotropium is superior to the β(2)-agonist salmeterol in preventing exacerbations of COPD.

methodsIn a 1-year, randomized, double-blind, double-dummy, parallel-group trial, we compared the effect of treatment with 18 μg of tiotropium once daily with that of 50 μg of salmeterol twice daily on the incidence of moderate or severe exacerbations in patients with moderate-to-very-severe COPD and a history of exacerbations in the preceding year.

resultsA total of 7376 patients were randomly assigned to and treated with tiotropium (3707 patients) or salmeterol (3669 patients). Tiotropium, as compared with salmeterol, increased the time to the first exacerbation (187 days vs. 145 days), with a 17% reduction in risk (hazard ratio, 0.83; 95% confidence interval [CI], 0.77 to 0.90; P<0.001). Tiotropium also increased the time to the first severe exacerbation (hazard ratio, 0.72; 95% CI, 0.61 to 0.85; P<0.001), reduced the annual number of moderate or severe exacerbations (0.64 vs. 0.72; rate ratio, 0.89; 95% CI, 0.83 to 0.96; P=0.002), and reduced the annual number of severe exacerbations (0.09 vs. 0.13; rate ratio, 0.73; 95% CI, 0.66 to 0.82; P<0.001). Overall, the incidence of serious adverse events and of adverse events leading to the discontinuation of treatment was similar in the two study groups. There were 64 deaths (1.7%) in the tiotropium group and 78 (2.1%) in the salmeterol group.

conclusionsThese results show that, in patients with moderate-to-very-severe COPD, tiotropium is more effective than salmeterol in preventing exacerbations. (Funded by Boehringer Ingelheim and Pfizer; ClinicalTrials.gov number, NCT00563381.).

Indexed as

Administration, InhalationAdrenergic beta-2 Receptor AgonistsAgedAlbuterolBronchodilator AgentsCholinergic AntagonistsDouble-Blind MethodDrug Therapy, CombinationFemaleGlucocorticoidsHumansKaplan-Meier EstimateMaleMiddle AgedPneumoniaProportional Hazards ModelsAdrenergic beta-2 Receptor AgonistsAlbuterolBronchodilator AgentsCholinergic AntagonistsGlucocorticoidsSalmeterol XinafoateScopolamine DerivativesTiotropium Bromide

Identifiers

PMID21428765
OpenAlexW2096723137

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.