Evidence map›Paper›PMID 26506314›Full record

ArticleBritish journal of clinical pharmacology2016

Tiotropium Respimat(®) vs. HandiHaler(®): real-life usage and TIOSPIR trial generalizability.

Sven Schmiedl, Rainald Fischer, Luisa Ibanez, Joan Fortuny, Petra Thürmann, Elena Ballarin, Pili Ferrer, Monica Sabaté, Dominik Rottenkolber, Roman Gerlach and 4 more

Open access · bronzeAbstract readComparative Study
In one paragraph

Article in British journal of clinical pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 25% 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.

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

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Efficacy and cardiovascular safety of LAMA in patients with COPD: a systematic review and meta-analysis.Journal of investigative medicine : the official publication of the American Federation for Clinical Research · 2021
    Pooled it
  2. Trial
  3. Article
  4. Article
  5. The RespimatClinical drug investigation · 2019
    Review
  6. Article
  7. Article
  8. Response to Wise et al. (Tiotropium safety in real life populations).British journal of clinical pharmacology · 2016
    Article
  9. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 10 institutions in 3 countries.

Sven SchmiedlDepartment of Clinical Pharmacology, School of Medicine, Faculty of Health, Witten/Herdecke University, Witten, Germany.
Rainald FischerPneumologische Praxis Muenchen - Pasing, Munich, Germany.
Luisa IbanezFundació Institut Català de Farmacologia, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
Joan FortunyNovartis Farmaceutica S.A., Barcelona, Spain.
Petra ThürmannDepartment of Clinical Pharmacology, School of Medicine, Faculty of Health, Witten/Herdecke University, Witten, Germany.
Elena BallarinFundació Institut Català de Farmacologia, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
Pili FerrerFundació Institut Català de Farmacologia, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
Monica SabatéFundació Institut Català de Farmacologia, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
Dominik RottenkolberInstitute of Health Economics and Management, Ludwig-Maximilians-Universitaet Muenchen, Munich, Germany.
Roman GerlachNational Association of Statutory Health Insurance Physicians of Bavaria, Munich, Germany.
Martin TauscherNational Association of Statutory Health Insurance Physicians of Bavaria, Munich, Germany.
Robert ReynoldsPfizer, New York, NY, USA.
Joerg HasfordInstitute for Medical Information Sciences, Biometry, and Epidemiology, Ludwig-Maximilians-Universitaet Muenchen, Munich, Germany.
Marietta RottenkolberInstitute for Medical Information Sciences, Biometry, and Epidemiology, Ludwig-Maximilians-Universitaet Muenchen, Munich, Germany.
Sociedad Española de Farmacología Clínica · ESLudwig-Maximilians-Universität München · DENational Association of Statutory Health Insurance Physicians · DEHelios Universitätsklinikum Wuppertal · DEHelmholtz Zentrum München · DENovartis (Spain) · ESOrthopädische Praxis · DEPfizer (United States) · USUniversitat Autònoma de Barcelona · ESWitten/Herdecke University · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTwo inhaler devices (Respimat® and HandiHaler®) are available for tiotropium, a long acting anticholinergic agent. We aimed to analyze drug utilization, off-label usage and generalizability of the TIOSPIR trial results for both devices.

methodsPatients aged ≥18 years exhibiting at least one documented prescription of tiotropium in the database of the Association of Statutory Health Insurance Physicians, Bavaria, Germany, were included (years 2004-2008). Annual period prevalence rates (PPRs) were calculated stratified by age, gender and inhaler devices. Off-label usage (patients lacking a chronic obstructive pulmonary disease (COPD) diagnosis) and the proportion of patients meeting the inclusion and exclusion criteria of the TIOSPIR trial were analyzed.

resultsBetween 2004 and 2008, PPRs increased and varied between 49.2 and 74.5 per 10 000 persons for HandiHaler® and between 1.5 and 9.3 per 10 000 persons for Respimat®. Small differences regarding patient characteristics existed between the two inhaler devices. Only about 30% (HandiHaler® 32.1%, Respimat® 30.0%) of the database patients receiving tiotropium could be theoretically included in the TIOSPIR trial.

conclusionsComparing the two tiotropium devices, no clinically relevant differences regarding patient and prescribing characteristics were revealed. Results of the TIOSPIR trial were generalizable only to a minority of our study patients, underlining the need for real-life data.

Indexed as

Dry Powder InhalersMetered Dose InhalersAdministration, InhalationAgedCholinergic AntagonistsClinical Trials as TopicDatabases, FactualDrug UtilizationFemaleHumansMaleOff-Label UsePulmonary Disease, Chronic ObstructiveTiotropium BromideCholinergic AntagonistsTiotropium BromideCOPDreal-life usagesecondary data analysisTIOSPIR trialtiotropium

Identifiers

PMID26506314
PMCPMC4833170
OpenAlexW1832934934

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.