Evidence map›Paper›PMID 26540491›Full record

Trial reportNPJ primary care respiratory medicine2015

Safety and efficacy of tiotropium Respimat versus HandiHaler in patients naive to treatment with inhaled anticholinergics: a post hoc analysis of the TIOSPIR trial.

Robert Wise, Peter M A Calverley, Ronald Dahl, Daniel Dusser, Norbert Metzdorf, Achim Müller, Andy Fowler, Antonio Anzueto

Abstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in NPJ primary care respiratory medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Trial
  2. Review
  3. Review
  4. Article
  5. Article
  6. Tiotropium formulations and safety: a network meta-analysis.Therapeutic advances in drug safety · 2017
    Article
  7. Response to Wise et al. (Tiotropium safety in real life populations).British journal of clinical pharmacology · 2016
    Article
  8. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Robert WiseDepartment of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Peter M A CalverleyRespiratory Medicine, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.
Ronald DahlAllergy Centre, Odense University Hospital, Odense C, Denmark.
Daniel DusserService de Pneumologie, Hôpital Cochin, AP-HP, Université Paris Descartes, Sorbonne Paris Cité, Paris, France.
Norbert MetzdorfMedical Affairs, Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany.
Achim MüllerGlobal Clinical Operations, Biometry and Data Management, Boehringer Ingelheim Pharma GmbH & Co KG, Biberach, Germany.
Andy FowlerMedical Affairs, Boehringer Ingelheim Pharma Ltd, Bracknell, UK.
Antonio AnzuetoDepartment of Medicine, Pulmonary Critical Care Center, University of Texas Health Science Center, San Antonio, TX, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients with chronic obstructive pulmonary disease (COPD) who were naive to anticholinergics before the TIOtropium Safety and Performance In Respimat (TIOSPIR) trial may reflect patients seen in practice, in particular in primary care. In addition, investigating safety in these patients avoids the potential bias in patients who previously received anticholinergics and may be tolerant of their effects.

aimsThe aim of this study was to evaluate whether patients naive to anticholinergic therapy who were treated with tiotropium Respimat 2.5 or 5 μg had different safety and efficacy outcomes than patients treated with tiotropium HandiHaler 18 μg.

methodsA post hoc analysis of patients who were not receiving anticholinergics before TIOSPIR (N=6,966/17,135) was conducted. Primary end points were risk of death from any cause and risk of COPD exacerbation. Secondary outcomes included severe exacerbation and major adverse cardiovascular events (MACE). Additional analysis of exacerbations was carried out in anticholinergic-naive patients with moderate (GOLD II) disease.

resultsAnticholinergic-naive patients had less severe disease than the total TIOSPIR population. Discontinuations because of anticholinergic side effects were infrequent (0.9% overall). Similar to the primary study, patients in the tiotropium Respimat groups had no difference in the risk of death or risk of any or severe exacerbation than patients treated with tiotropium HandiHaler. Risk of MACE was similar across the Respimat and HandiHaler groups. Rates of exacerbations in the subgroup of patients with moderate disease were similar across the Respimat and HandiHaler groups.

conclusionsTiotropium Respimat and HandiHaler have similar safety and efficacy profiles in patients who are naive to anticholinergic therapy.

Indexed as

Dry Powder InhalersAdministration, InhalationAgedCholinergic AntagonistsDouble-Blind MethodFemaleForced Expiratory VolumeHumansMaleMiddle AgedNebulizers and VaporizersProportional Hazards ModelsPulmonary Disease, Chronic ObstructiveTiotropium BromideTreatment OutcomeVital CapacityCholinergic AntagonistsTiotropium Bromide

Identifiers

PMID26540491
PMCPMC4634206

What OpenQuestion holds

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Registered trials

None linked

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.