Evidence map›Paper›PMID 34103906›Full record

ArticleInternational journal of chronic obstructive pulmonary disease

A Cohort Study to Evaluate the Risk of Hospitalisation for Congestive Heart Failure Associated with the Use of Aclidinium and Other Chronic Obstructive Pulmonary Disease Medications in the UK Clinical Practice Research Datalink.

Cristina Rebordosa, Estel Plana, Annalisa Rubino, Jaume Aguado, Alejhandra Lei, Sami Daoud, Nuria Saigi-Morgui, Susana Perez-Gutthann, Elena Rivero-Ferrer

Open access · goldAbstract read
In one paragraph

Article in International journal of chronic obstructive pulmonary disease. 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
0.3field-weighted citation impact, top 41% 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, 3 citations in OpenAlex.

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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

9 authors at 3 institutions in 3 countries.

Cristina RebordosaRTI Health Solutions, Barcelona, Spain.
Estel PlanaRTI Health Solutions, Barcelona, Spain.
Annalisa RubinoEpidemiology, Respiratory and Immunology, AstraZeneca, Cambridge, UK.
Jaume AguadoRTI Health Solutions, Barcelona, Spain.
Alejhandra LeiPatient Safety Biopharma, AstraZeneca, Barcelona, Spain.
Sami DaoudBioPharmaceuticals Research and Development, Late-Stage Development Research and Innovation, AstraZeneca, Gaithersburg, MD, USA.
Nuria Saigi-MorguiRTI Health Solutions, Barcelona, Spain.
Susana Perez-GutthannRTI Health Solutions, Barcelona, Spain.ORCID 0000-0001-5798-3691
Elena Rivero-FerrerRTI Health Solutions, Barcelona, Spain.ORCID 0000-0001-5093-2445
AstraZeneca (Spain) · ESAstraZeneca (United Kingdom) · GBAstraZeneca (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe long-acting anticholinergic (LAMA) aclidinium was approved in Europe in 2012 to relieve symptoms in adults with chronic obstructive pulmonary disease (COPD). A Post-Authorisation Safety Study (PASS) was initiated to assess potential cardiovascular safety concerns for aclidinium.

objectiveTo estimate the adjusted incidence rate ratio (IRR) for hospitalisation for heart failure in patients with COPD who were new users of aclidinium, tiotropium, other LAMA, long-acting beta-agonists/inhaled corticosteroids (LABA/ICS), and LAMA/LABA were compared with initiators of LABA.

methodsThis population-based cohort study included patients with COPD aged ≥40 years initiating COPD medications in the Clinical Practice Research Datalink (CPRD) GOLD in the United Kingdom from 2012 to 2017. Medications were identified via general practice prescriptions. The first-ever hospitalisations for heart failure were identified in the Hospital Episode Statistics, and general practitioner records from the CPRD. Poisson regression models were used to estimate the IRR for hospitalisation for heart failure in users of COPD medications versus LABA, adjusting for clinically relevant covariates.

resultsThe study included 4350 new users of aclidinium, 23,405 of tiotropium, 6977 of other LAMAs, 3122 of LAMA/LABA, 26,093 of LABA/ICS, and 5678 of LABA. Mean age was 69-70 years across medication groups. Aclidinium users had the highest proportion of severe COPD, and LABA users had the lowest (35% vs 19%, respectively). Crude incidence rates per 1000 person-years for the first-ever hospitalisation for heart failure ranged from 6.9 in LABA to 9.5 in aclidinium. Using LABA as reference, adjusted IRRs (95% confidence interval) for first-ever hospitalisation for heart failure were 0.90 (0.53-1.53) for aclidinium, 1.02 (0.69-1.51) for tiotropium, 0.86 (0.50-1.47) for other LAMAs, 1.09 (0.41-2.92) for LAMA/LABA, and 1.01 (0.69, 1.48) for LABA/ICS.

conclusionThe study did not find increased risks of hospitalisations for heart failure in new users of aclidinium, tiotropium, other LAMAs, LAMA/LABA, and LABA/ICS compared with LABA.

Indexed as

Heart FailurePulmonary Disease, Chronic ObstructiveAdministration, InhalationAdrenal Cortex HormonesAdrenergic beta-2 Receptor AgonistsAdultAgedBronchodilator AgentsCohort StudiesDrug Therapy, CombinationEuropeHospitalizationHumansMuscarinic AntagonistsUnited KingdomAdrenal Cortex HormonesAdrenergic beta-2 Receptor AgonistsBronchodilator AgentsMuscarinic Antagonistsaclidiniumheart failureLAMAUnited Kingdom

Identifiers

PMID34103906
PMCPMC8180309
OpenAlexW3168006690

What OpenQuestion holds

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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.