Evidence map›Paper›PMID 31749061›Full record

ArticleDrugs2020

Comparative Safety Profile of the Fixed-Dose Combination Corticosteroid and Long-acting β

David B Price, Victoria Carter, Jessica Martin, Elizabeth A Gardener, Derek Skinner, Sen Yang, Matthias Hoffman, Jenna C Willis, Andrew J Cooper

Abstract readComparative Study
PubMed Publisher
In one paragraph

Article in Drugs, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.0field-weighted citation impact, top 22% 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

2 citing papers in PubMed, 9 citations in OpenAlex.

  1. Association between Inhaled βInternational journal of chronic obstructive pulmonary disease · 2022
    Article
  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

9 authors at 4 institutions in 3 countries.

David B PriceCentre of Academic Primary Care, Division of Applied Health Services, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, AB25 2ZD, UK. dprice@opri.sg.ORCID http://orcid.org/0000-0002-9728-9992
Victoria CarterObservational and Pragmatic Research Institute, Singapore City, Singapore.
Jessica MartinObservational and Pragmatic Research Institute, Singapore City, Singapore.
Elizabeth A GardenerObservational and Pragmatic Research Institute, Singapore City, Singapore.
Derek SkinnerObservational and Pragmatic Research Institute, Singapore City, Singapore.
Sen YangObservational and Pragmatic Research Institute, Singapore City, Singapore.
Matthias HoffmanMundipharma Research GmbH and Co. KG, Höhenstraße 10, 65549, Limburg, Germany.
Jenna C WillisMundipharma Research Ltd., Cambridge Science Park, Milton Road, Cambridge, CB4 0AB, UK.
Andrew J CooperMundipharma Research Ltd., Cambridge Science Park, Milton Road, Cambridge, CB4 0AB, UK.
Observational & Pragmatic Research Institute · SGMundipharma (United Kingdom) · GBMundipharma (Germany) · DEUniversity of Aberdeen · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe inhaled corticosteroid/long-acting β

methodsHistorical, longitudinal cohort database study using UK primary care data from the Clinical Practice Research Datalink (CPRD) database, for patients initiated on or switched to an FDC ICS/LABA (ENCePP study number: EUPAS12330). The main cohort was adults aged ≥ 18 years with asthma. The primary outcome was incidence of new adverse outcomes after initiation of ICS/LABA; hazard ratios (HRs) and 95% confidence intervals were estimated for FP/FORM versus other FDC ICS/LABAs using Cox regression models.

resultsA total of 241,007 patients with an FDC ICS/LABA prescription were identified. In the adult asthma cohort (N = 41,609), the incidence rate of new adverse outcomes [in 100 patient-years (py)] was significantly lower for FP/FORM (24.75) versus fluticasone/salmeterol metered-dose inhaler [8.86; HR 1.14 (1.04, 1.25)], fluticasone/salmeterol dry powder inhaler [31.19; HR 1.18 (1.08, 1.29)], budesonide/formoterol [25.16; HR: 1.13 (1.03, 1.25)] and beclometasone/formoterol [25.47; HR 1.14 (1.04, 1.25)]. The overall prescribing rate was lower for FP/FORM (13.85 per 1000/py) than licensed FDC ICS/LABA comparators (20.30-28.13 per 1000/py). Of those prescribed FP/FORM, 80.8% were adults with asthma and < 7% were prescribed FP/FORM "off-label".

conclusionsThe results suggest that FP/FORM was associated with an overall lower adverse outcome rate than the licensed comparators.

Indexed as

Administration, InhalationAdultAgedAnti-Asthmatic AgentsAsthmaBeclomethasoneBudesonide, Formoterol Fumarate Drug CombinationCohort StudiesDrug CombinationsFemaleFluticasoneFluticasone-Salmeterol Drug CombinationFormoterol FumarateHumansLongitudinal StudiesMaleAnti-Asthmatic AgentsBeclomethasoneBudesonide, Formoterol Fumarate Drug CombinationDrug CombinationsFluticasonefluticasone-formoterolFluticasone-Salmeterol Drug CombinationFormoterol Fumarate

Identifiers

PMID31749061
OpenAlexW2989620762

What OpenQuestion holds

Textmetadata
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.