Evidence map›Paper›PMID 34686204›Full record

Trial reportRespiratory research2021

Long-acting antimuscarinic therapy in patients with chronic obstructive pulmonary disease receiving beta-blockers.

Kenneth R Chapman, Robert A Wise, Benjamin M Scirica, Deepak L Bhatt, Sami Z Daoud, Dan Lythgoe, Esther Garcia Gil

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IVComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Respiratory research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01966107 (Double-blind, Randomized, Placebo-controlled, Parallel-group, Phase IV Study to Evaluate the Effect of Aclidinium Bromide on Long-term Cardiovascular Safety and COPD Exacerbations in Patients With Moderate to Very Severe COPD), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.6field-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.

NCT01966107 phase4completednot on this map

Double-blind, Randomized, Placebo-controlled, Parallel-group, Phase IV Study to Evaluate the Effect of Aclidinium Bromide on Long-term Cardiovascular Safety and COPD Exacerbations in Patients With Moderate to Very Severe COPD (ASCENT COPD)

TypeinterventionalSponsorAstraZenecaRan2013 to 2017Enrolled3,635ConditionsCOPD, Chronic Obstructive Pulmonary Disease, Moderate to Very Severe COPDArmsAclidinium Bromide, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 6 citations in OpenAlex.

  1. Review
  2. 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

7 authors at 5 institutions in 3 countries.

Kenneth R ChapmanAsthma and Airway Centre, University of Toronto, Toronto, ON, Canada. kchapman@ca.inter.net.ORCID http://orcid.org/0000-0002-2498-9859
Robert A WisePulmonary Function Laboratory, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Benjamin M SciricaDivision of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Deepak L BhattDivision of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Sami Z DaoudLate-Stage Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
Dan LythgoeStatistics, Phastar, Chiswick, London, UK.
Esther Garcia GilFormerly of AstraZeneca, Barcelona, Spain.
Brigham and Women's Hospital · USAstraZeneca (Spain) · ESAstraZeneca (United States) · USJohns Hopkins University · USUniversity Health Network · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBeta-blocker therapies for cardiovascular comorbidities are often withheld in patients with chronic obstructive pulmonary disease (COPD) due to potential adverse effects on airway obstruction. We carried out a post hoc analysis to determine the efficacy and safety of aclidinium in patients with moderate-to-very severe COPD and increased cardiovascular risk receiving beta-blockers at baseline versus non-users.

methodsASCENT-COPD was a Phase 4, multicenter, double-blind, randomized, placebo-controlled, parallel-group study. Patients were randomized 1:1 to aclidinium or placebo twice-daily for up to 3 years. Outcomes included risk of (time to first) major adverse cardiovascular events (MACE), all-cause mortality, and lung function over 3 years, and exacerbations over 1 year.

resultsOf 3589 patients, 1269 (35.4%) used beta-blockers and 2320 (64.6%) were non-users at baseline. Aclidinium did not statistically increase the risk of MACE (beta-blocker user: hazard ratio 1.01 [95% CI 0.62-1.64]; non-user: 0.80 [0.51-1.24]; interaction P = 0.48) or all-cause mortality (beta-blocker user: 1.13 [0.78-1.64]; non-user: 0.89 [0.62-1.26]; interaction P = 0.35), in patients using beta-blockers. Aclidinium reduced annualized rate of moderate-to-severe COPD exacerbation (beta-blocker user: rate ratio 0.75 [95% CI 0.60-0.94, P = 0.013]; non-user: 0.79 [0.67-0.93, P = 0.005]), delayed time to first exacerbation, and improved lung function versus placebo. There was greater trough FEV

conclusionsThis post hoc analysis supports long-acting anti-muscarinic use with concomitant beta-blockers in patients with moderate-to-very severe COPD and cardiovascular comorbidity.

trial registrationClinicalTrials.gov, NCT01966107, Registered 16 October 2013, https://clinicaltrials.gov/ct2/show/NCT01966107 .

Indexed as

Adrenergic beta-AntagonistsAgedCanadaDisease ProgressionDouble-Blind MethodDrug Therapy, CombinationFemaleForced Expiratory VolumeHumansLungMaleMiddle AgedMuscarinic AntagonistsPulmonary Disease, Chronic ObstructiveRecovery of FunctionSeverity of Illness Indexaclidinium bromideAdrenergic beta-AntagonistsMuscarinic AntagonistsTropanesAclidiniumBeta-adrenergic antagonistsCardiac riskExacerbations

Identifiers

PMID34686204
PMCPMC8532273
OpenAlexW3206545441

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.