Evidence map›Paper›PMID 26031308›Full record

Trial reportRespiratory research2015

Cardiac safety of tiotropium in patients with cardiac events: a retrospective analysis of the UPLIFT® trial.

Donald P Tashkin, Inge Leimer, Norbert Metzdorf, Marc Decramer

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Respiratory research, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 2 pooled it
6.0field-weighted citation impact, top 3% 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

21 citing papers in PubMed, 2 syntheses or guidelines pooled it, 49 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. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Long-term safety of tiotropium/olodaterol RespimatInternational journal of chronic obstructive pulmonary disease · 2018
    Trial
  8. Article
  9. Review
  10. Review
  11. Article
  12. Effectiveness and safety of concurrent beta-blockers and inhaled bronchodilators in COPD with cardiovascular comorbidities.European respiratory review : an official journal of the European Respiratory Society · 2017
    Review
  13. Tiotropium formulations and safety: a network meta-analysis.Therapeutic advances in drug safety · 2017
    Article
  14. Article
  15. Response to Wise et al. (Tiotropium safety in real life populations).British journal of clinical pharmacology · 2016
    Article
  16. Article
  17. Article
  18. Observational
  19. Review
  20. 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

4 authors at 3 institutions in 3 countries.

Donald P TashkinDepartment of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA. dtashkin@mednet.ucla.edu.
Inge LeimerMedical Affairs, Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany. inge.leimer@boehringer-ingelheim.com.
Norbert MetzdorfMedical Affairs, Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany. norbert.metzdorf@boehringer-ingelheim.com.
Marc DecramerRespiratory Division, University of Leuven, Leuven, Belgium. marc.decramer@uzleuven.be.
Boehringer Ingelheim (Germany) · DEKU Leuven · BEUniversity of California, Los Angeles · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTiotropium is an anticholinergic bronchodilator for symptom relief and reducing exacerbations with an established safety profile in patients with chronic obstructive pulmonary disease (COPD). Using data from the 4-year Understanding Potential Long-term Impacts on Function with Tiotropium (UPLIFT®) study, we re-evaluated the safety of tiotropium HandiHaler® in patients who experienced recent myocardial infarction (MI), heart failure or unstable rhythm disorder during the study.

methodsA post-hoc analysis of all-cause mortality and serious cardiac adverse events (cardiac SAEs), including cardiac deaths and death unknown, was conducted in patients who had experienced cardiac arrhythmia, MI or cardiac failure during UPLIFT® and who completed the study. Descriptive analyses were performed.

resultsMost patients experiencing cardiac events, for which they would have been excluded at baseline, remained in the trial. Kaplan-Meier analyses revealed a trend to later occurrence of cardiac SAEs with tiotropium HandiHaler® versus placebo. Patients who experienced a cardiac event and continued in UPLIFT® were not found to be at subsequently increased risk of all-cause mortality or cardiac SAEs with tiotropium treatment. Evaluation of deaths by major adverse cardiac events composite endpoints also showed that patients treated with tiotropium were not at increased risk of mortality or cardiac SAEs compared with placebo.

conclusionsRisk of cardiac events, mortality or SAEs was not increased by tiotropium in patients experiencing cardiac events for which they would have been excluded at study baseline. The findings support the cardiac safety of tiotropium HandiHaler® in patients with COPD.

Indexed as

Bronchodilator AgentsCardiovascular DiseasesDouble-Blind MethodFemaleHumansMaleMortalityPulmonary Disease, Chronic ObstructiveRetrospective StudiesTiotropium BromideBronchodilator AgentsTiotropium Bromide

Identifiers

PMID26031308
PMCPMC4475325
OpenAlexW1490958657

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.