Evidence map›Paper›PMID 28416587›Full record

Trial reportHeart (British Cardiac Society)2017

Cardiovascular outcomes with an inhaled beta2-agonist/corticosteroid in patients with COPD at high cardiovascular risk.

Robert D Brook, Julie A Anderson, Peter Ma Calverley, Bartolome R Celli, Courtney Crim, Martin A Denvir, Sheldon Magder, Fernando J Martinez, Sanjay Rajagopalan, Jørgen Vestbo and 3 more

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Heart (British Cardiac Society), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01313676 (A Clinical Outcomes Study to Compare the Effect of Fluticasone Furoate/Vilanterol Inhalation Powder 100/25mcg With Placebo on Survival in Subjects With Moderate Chronic Obstructive Pulmonary Disease), which is not on this map. Cited by 25 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 2 pooled it
7.4field-weighted citation impact, top 2% 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.

NCT01313676 phase3completednot on this map

A Clinical Outcomes Study to Compare the Effect of Fluticasone Furoate/Vilanterol Inhalation Powder 100/25mcg With Placebo on Survival in Subjects With Moderate Chronic Obstructive Pulmonary Disease (COPD) and a History of or at Increased Risk for Cardiovascular Disease

TypeinterventionalSponsorGlaxoSmithKlineRan2011 to 2015Enrolled16,568ConditionsPulmonary Disease, Chronic ObstructiveArmsfluticasone furoate/vilanterol, fluticasone furoate, vilanterol, Placebo
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 2 syntheses or guidelines pooled it, 50 citations in OpenAlex.

  1. Systematic review on long-term adverse effects of inhaled corticosteroids in the treatment of COPD.European respiratory review : an official journal of the European Respiratory Society · 2021
    Pooled it
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  9. Article
  10. Review
  11. Immunometabolism in heart failure.Nature reviews. Cardiology · 2025
    Review
  12. βBiochemistry research international · 2025
    Review
  13. The role of glucocorticoids in increasing cardiovascular risk.Frontiers in cardiovascular medicine · 2023
    Article
  14. Article
  15. Article
  16. Review
  17. Shared mechanisms of multimorbidity in COPD, atherosclerosis and type-2 diabetes: the neutrophil as a potential inflammatory target.European respiratory review : an official journal of the European Respiratory Society · 2020
    Review
  18. Article
  19. Article
  20. Review
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

13 authors at 10 institutions in 3 countries.

Robert D BrookDivision of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan, USA.
Julie A AndersonResearch & Development, GlaxoSmithKline, Uxbridge, UK.
Peter Ma CalverleyDepartment of Medicine, University of Liverpool, Liverpool, UK.
Bartolome R CelliPulmonary and Critical Care Division, Brigham and Womens Hospital, Harv'ard Medical School, Boston, Massachusetts, USA.
Courtney CrimResearch & Development, GSK, Research Triangle Park, North Carolina, USA.
Martin A DenvirCentre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.
Sheldon MagderResearch Institute of the McGill University Health Centre, McGill University, Montreal, Canada.
Fernando J MartinezJoan and Sandy Weill Department of Medicine, Weill Cornell Medicine, New York, New York, USA.
Sanjay RajagopalanCardiovascular Medicine, University of Maryland, College Park, Maryland, USA.
Jørgen VestboCentre for Respiratory Medicine and Allergy, Manchester Academic Health Science Centre, The University of Manchester and South Manchester University Hospital NHS Foundation Trust, Manchester, UK.
Julie YatesResearch & Development, GSK, Research Triangle Park, North Carolina, USA.
David E NewbyBritish Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.
SUMMIT Investigators
Research Triangle Park Foundation · USUniversity of Edinburgh · GBAintree University Hospital · GBGlaxoSmithKline (United Kingdom) · GBHarvard University · USManchester Academic Health Science Centre · GBMcGill University Health Centre · CAUniversity of Maryland, College Park · USUniversity of Michigan–Ann Arbor · USWeill Cornell Medicine · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesCardiovascular disease (CVD) and chronic obstructive pulmonary disease (COPD) often coexist. We assessed the effect of inhaled COPD treatments on CVD outcomes and safety in patients with COPD and at heightened CVD risk.

methodsThe SUMMIT (Study to Understand Mortality and MorbidITy) was a multicentre, randomised, double-blind, placebo-controlled, event-driven trial in 16 485 patients with moderate COPD who had or were at high risk of CVD. Here, we assessed the prespecified secondary endpoint of time to first on-treatment composite CVD event (CVD death, myocardial infarction, stroke, unstable angina or transient ischaemic attack (TIA)) by Cox regression and by clinician-reported CVD adverse events across the four groups: once-daily inhaled placebo (n=4111), long-acting beta

resultsParticipants were predominantly middle-aged (mean 65 (SD 8) years) men (75%) with overt CVD (66%). The composite CVD endpoint occurred in 688 patients (first event: sudden death (35%), acute coronary syndrome (37%) and stroke or TIA (23%), and was not reduced in any treatment group versus placebo: VI (HR 0.99, 95% CI 0.80 to 1.22), FF (HR 0.90, 95% CI 0.72 to 1.11) and their combination (HR 0.93, 95% CI 0.75 to 1.14). Outcomes were similar among all subgroups. Adverse events, including palpitations and arrhythmias, did not differ by treatment.

conclusionsIn patients with COPD with moderate airflow limitation and heightened CVD risk, treatment with inhaled VI, FF or their combination has an excellent safety profile and does not impact CVD outcomes. TRIAL REGISTRATION NUMBER: NCT01313676.

Indexed as

Administration, InhalationAdrenergic beta-2 Receptor AntagonistsAdultAgedAged, 80 and overAndrostadienesBenzyl AlcoholsCardiovascular DiseasesChlorobenzenesDose-Response Relationship, DrugDouble-Blind MethodDrug CombinationsFemaleFollow-Up StudiesForced Expiratory VolumeGlucocorticoidsAdrenergic beta-2 Receptor AntagonistsAndrostadienesBenzyl AlcoholsChlorobenzenesDrug Combinationsfluticasone furoateGlucocorticoidsvilanterolcardiovascular diseaseinhaler therapiespulmonary disease

Identifiers

PMID28416587
PMCPMC5629944
OpenAlexW2606915282

What OpenQuestion holds

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LicenceCC BY-NC
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.