Evidence map›Paper›PMID 28430820›Full record

ArticlePloS one2017

Cardiovascular safety of tiotropium Respimat vs HandiHaler in the routine clinical practice: A population-based cohort study.

Francesco Trotta, Stefania Spila-Alegiani, Roberto Da Cas, Maja Rajevic, Valentino Conti, Mauro Venegoni, Mariangela Rossi, Giuseppe Traversa

Open access · goldAbstract read
In one paragraph

Article in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.9field-weighted citation impact, top 24% 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

3 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Review
  3. 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 at 4 institutions in 1 country.

Francesco TrottaDepartment of Epidemiology, Lazio Regional Health Service, Rome, Italy.
Stefania Spila-AlegianiPharmacoepidemiology Unit, National Centre for Epidemiology, National Institute of Health, Rome, Italy.
Roberto Da CasPharmacoepidemiology Unit, National Centre for Epidemiology, National Institute of Health, Rome, Italy.
Maja RajevicPhD Course, Pharmaceutical Sciences, Drug Chemistry and Technologies Department, "La Sapienza" University of Rome, Rome, Italy.
Valentino ContiRegional Center for Pharmacovigilance, General Directorate for Health, The Lombardy Region, Milan, Italy.
Mauro VenegoniRegional Center for Pharmacovigilance, General Directorate for Health, The Lombardy Region, Milan, Italy.
Mariangela RossiUnit for Pharmaceutical Governance, General Directorate for Health, Umbria Region, Perugia, Italy.
Giuseppe TraversaPharmacoepidemiology Unit, National Centre for Epidemiology, National Institute of Health, Rome, Italy.
National Centre for Disease Prevention and Control · ITRegione LombardiaRegione UmbriaSapienza University of Rome · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The cardiovascular safety of tiotropium Respimat formulation in the routine clinical practice is still an open issue. Our aim was to compare the risk of acute myocardial infarction and heart rhythm disorders in incident users of either tiotropium Respimat or HandiHaler. The study population comprises patients aged ≥45 years, resident in two Italian regions with a first prescription of tiotropium (HandiHaler or Respimat) between 01/07/2011-30/11/2013. The cohort was identified through the database of prescriptions reimbursed by the Italian National Health Service. Comorbidities and clinical outcomes were obtained from hospital records. The primary outcome was the first hospitalization for acute myocardial infarction and/or for heart rhythm disorders during the exposure period. Hazard ratios were estimated in the propensity score-matched groups through Cox regression. After matching, 31,334 patients with incident prescription of tiotropium were included. The two groups were balanced with regard to baseline characteristics. Similar incidence rates of the primary outcome between Respimat and HandiHaler users were identified (adjusted hazard ratio 1.02, 95% CI 0.82-1.28). No risk difference between Respimat and HandiHaler emerged when considering clinical events separately. This large cohort study showed a comparable acute cardiovascular safety profile of the two tiotropium formulations.

Indexed as

AgedAged, 80 and overBronchodilator AgentsCohort StudiesFemaleHumansMaleMiddle AgedTiotropium BromideBronchodilator AgentsTiotropium Bromide

Identifiers

PMID28430820
PMCPMC5400270
OpenAlexW2606958086

What OpenQuestion holds

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LicenceCC BY
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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.