Evidence map›Paper›PMID 30176872›Full record

Trial reportRespiratory research2018

Anti-acid therapy in idiopathic pulmonary fibrosis: insights from the INPULSIS® trials.

Ulrich Costabel, Jürgen Behr, Bruno Crestani, Wibke Stansen, Rozsa Schlenker-Herceg, Susanne Stowasser, Ganesh Raghu

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Respiratory research, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 25 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 1 pooled it
5.5field-weighted citation impact, top 3% 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.

NCT01335464 phase3completednot on this map

A 52 Weeks, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of Oral BIBF 1120, 150 mg Twice Daily, on Annual Forced Vital Capacity Decline, in Patients With Idiopathic Pulmonary Fibrosis (IPF)

TypeinterventionalSponsorBoehringer IngelheimRan2011 to 2013Enrolled515ConditionsPulmonary FibrosisArmsplacebo, BIBF 1120
NCT01335477 phase3completednot on this map

A 52 Weeks, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of Oral BIBF 1120, 150 mg Twice Daily, on Annual Forced Vital Capacity Decline, in Patients With Idiopathic Pulmonary Fibrosis (IPF)

TypeinterventionalSponsorBoehringer IngelheimRan2011 to 2013Enrolled551ConditionsPulmonary FibrosisArmsplacebo, BIBF 1120
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 1 synthesis or guideline pooled it, 54 citations in OpenAlex.

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  19. Management of Idiopathic Pulmonary Fibrosis.The Annals of pharmacotherapy · 2019
    Review
  20. Comorbidities in idiopathic pulmonary fibrosis: an underestimated issue.European respiratory review : an official journal of the European Respiratory Society · 2019
    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 6 institutions in 3 countries.

Ulrich CostabelRuhrlandklinik, University Hospital, University of Duisburg-Essen, Essen, Germany.
Jürgen BehrMedizinische Klinik und Poliklinik V, University of Munich (LMU) and Asklepios Klinik München-Gauting, Member of the German Center for Lung Research, Munich, Germany.
Bruno CrestaniAPHP, Hôpital Bichat, Service de Pneumologie A, DHU FIRE; INSERM, Unité 1152; Université Paris Diderot, Paris, France.
Wibke StansenBoehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.
Rozsa Schlenker-HercegBoehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT, USA.
Susanne StowasserBoehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.
Ganesh RaghuUniversity of Washington, Seattle, WA, USA. graghu@uw.edu.
Boehringer Ingelheim (Germany) · DEBoehringer Ingelheim (United States) · USHôpital Bichat-Claude-Bernard · FRLudwig-Maximilians-Universität München · DERuhrlandklinik · DEUniversity of Washington · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe benefits and risks of anti-acid medication in patients with idiopathic pulmonary fibrosis (IPF) remain a topic of debate. We investigated whether use of anti-acid medication at baseline was associated with differences in the natural course of disease or influenced the treatment effect of nintedanib in patients with IPF.

methodsPost-hoc analyses of outcomes in patients receiving versus not receiving anti-acid medication (proton pump or histamine-2 receptor inhibitor) at baseline using pooled data from the two Phase III randomized placebo-controlled INPULSIS® trials of nintedanib in patients with IPF.

resultsAt baseline, 406 patients were receiving anti-acid medication (244 nintedanib; 162 placebo) and 655 were not (394 nintedanib; 261 placebo). In an analysis of the natural course of IPF by anti-acid medication use at baseline, the adjusted annual rate of decline in FVC was - 252.9 mL/year in placebo-treated patients who were receiving anti-acid medication at baseline and - 205.4 mL/year in placebo-treated patients who were not (difference of - 47.5 mL/year [95% CI: -105.1, 10.1]; p = 0.1057). In an analysis of the potential influence of anti-acid medication use on the treatment effect of nintedanib, the adjusted annual rates of decline in FVC were - 124.4 mL/year in the nintedanib group and - 252.9 mL/year in the placebo group (difference of 128.6 mL/year [95% CI: 74.9, 182.2]) in patients who were receiving anti-acid medication at baseline and - 107.0 mL/year in the nintedanib group and - 205.3 mL/year in the placebo group (difference of 98.3 mL/year [95% CI: 54.1, 142.5]) in patients who were not (treatment-by-time-by-subgroup interaction p = 0.3869). The proportions of patients who had ≥1 investigator-reported acute exacerbation were 11.7% and 5.0% in placebo-treated patients, and 4.9% and 4.8% of nintedanib-treated patients, among patients who were and were not receiving anti-acid medication at baseline, respectively.

conclusionsIn post-hoc analyses of data from the INPULSIS® trials, anti-acid medication use at baseline was not associated with a more favorable course of disease, and did not impact the treatment effect of nintedanib, in patients with IPF.

trial registrationClinicalTrials.gov identifiers: NCT01335464 and NCT01335477 .

Indexed as

AgedAntacidsFemaleHumansIdiopathic Pulmonary FibrosisMaleMiddle AgedProspective StudiesTreatment OutcomeAntacids

Identifiers

PMID30176872
PMCPMC6122773
OpenAlexW2889546949

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.