Evidence map›Paper›PMID 31047114›Full record

ArticleRespiratory medicine2019

Re-evaluation of combination therapy in chronic obstructive pulmonary disease (COPD).

Carlos A Vaz Fragoso, Thomas M Gill, Linda S Leo-Summers, Peter H Van Ness

Open access · greenAbstract read
In one paragraph

Article in Respiratory medicine, 2019. 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
0.5field-weighted citation impact, top 30% 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, 5 citations in OpenAlex.

  1. Trial
  2. Article
  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

4 authors at 1 institution in 1 country.

Carlos A Vaz FragosoVeterans Affairs (VA) Connecticut Healthcare System, West Haven, CT, USA; Yale University School of Medicine, Department of Internal Medicine, New Haven, CT, USA. Electronic address: carlos.fragoso@yale.edu.
Thomas M GillYale University School of Medicine, Department of Internal Medicine, New Haven, CT, USA.
Linda S Leo-SummersYale University School of Medicine, Department of Internal Medicine, New Haven, CT, USA.
Peter H Van NessYale University School of Medicine, Department of Internal Medicine, New Haven, CT, USA.
Yale University · US

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Yale Study Support Suite (YES3): Dashboard and Web Portal Software Supporting Research Workflow through integrated, customizable REDCap External ModulesP30AG021342 · NIA · YALE UNIVERSITY · PI Albert C Shaw · 2002 to 2026
$37.9M
ACADEMIC LEADERSHIP AWARD IN DISABILITY AND DISABLING DISORDERSK07AG043587 · NIA · YALE UNIVERSITY · PI GILL, THOMAS MICHAEL · 2013 to 2017
$645k
COPD Pharmacotherapy in Aging PopulationsR03AG057450 · NIA · YALE UNIVERSITY · PI FRAGOSO, CARLOS A. VAZ · 2018 to 2019
$168k
NCATS NIH HHS UL1 TR001863NIA NIH HHS K07 AG043587NIA NIH HHS P30 AG021342NIA NIH HHS R03 AG057450
6 · The paper itself

Abstract

backgroundClinical trials of COPD pharmacotherapy typically involve aging populations with moderate-to-severe COPD, but the latter is often diagnosed by spirometric criteria that are not age-appropriate across the continuum of lung function. We have therefore re-evaluated the clinical effect of combination therapy (salmeterol plus fluticasone) in moderate-to-severe COPD, using more age-appropriate spirometric criteria from the Global Lung Function Initiative (GLI) and trial data from Towards a Revolution in COPD Health (TORCH).

methodsOf the 6112 TORCH participants, 5688 (93.1%) had GLI-based moderate-to-severe COPD (mean age 64.8 years). The primary outcome was all-cause mortality and the primary comparison was combination therapy vs. placebo. Secondary outcomes included COPD and cardiovascular (CV) mortality and pneumonia. A modified intention-to-treat analysis evaluated differences in time-to-event over a three-year period, using Cox proportional hazards models with statistical significance at p < 0.010 (acknowledging repeated significance testing).

resultsRelative to placebo, combination therapy yielded a statistically non-significant reduction in all-cause mortality-adjusted hazard ratio [adjHR] 0.78 (95% confidence interval [CI]: 0.64, 0.95), p = 0.012. Relative to placebo, combination therapy also yielded statistically non-significant reductions in COPD and CV mortality-adjHR 0.75 (95% CI: 0.55, 1.02), p = 0.068 and adjHR 0.76 (95% CI: 0.53, 1.09), p = 0.135, respectively. In contrast, combination therapy yielded a statistically significant increased risk of pneumonia, relative to placebo-adjHR 1.80 (95% CI: 1.46, 2.21), p < 0.001.

conclusionIn GLI-based moderate-to-severe COPD, combination therapy yields a statistically significant increased risk of pneumonia but the reductions in mortality are not statistically significant, although could potentially be clinically meaningful.

Indexed as

AgedBronchodilator AgentsCardiovascular DiseasesFemaleFluticasoneFluticasone-Salmeterol Drug CombinationHumansMaleMiddle AgedMulticenter Studies as TopicPneumoniaProportional Hazards ModelsPulmonary Disease, Chronic ObstructiveRandomized Controlled Trials as TopicSalmeterol XinafoateSeverity of Illness IndexBronchodilator AgentsFluticasoneFluticasone-Salmeterol Drug CombinationSalmeterol XinafoateCOPDMortalityPharmacotherapyPneumoniaSpirometry

Identifiers

PMID31047114
PMCPMC6519718
OpenAlexW2934579949

What OpenQuestion holds

Textmetadata
LicenceTDM
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.