Evidence map›Paper›PMID 19996196›Full record

Trial reportThe European respiratory journal2010

Pirfenidone in idiopathic pulmonary fibrosis.

H Taniguchi, M Ebina, Y Kondoh, T Ogura, A Azuma, M Suga, Y Taguchi, H Takahashi, K Nakata, A Sato and 5 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The European respiratory journal, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02932566 (A Randomised, Double-blind, Placebo-controlled, Phase 2 Study of the Efficacy and Safety of Pirfenidone in Patients With Heart Failure and Preserved Left Ventricular Ejection Fraction), which is not on this map. Cited by 407 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
407citing papers in PubMed, 8 pooled it
31.5field-weighted citation impact, top 1% 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.

NCT02932566 phase2completednot on this mapstarted 2017, after this paper: background citation

A Randomised, Double-blind, Placebo-controlled, Phase 2 Study of the Efficacy and Safety of Pirfenidone in Patients With Heart Failure and Preserved Left Ventricular Ejection Fraction (PIROUETTE)

TypeinterventionalSponsorManchester University NHS Foundation TrustRan2017 to 2020Enrolled129ConditionsCardiac FailureArmsPirfenidone, Placebo
3 · Its place in the literature

Who cites it

407 citing papers in PubMed, 8 syntheses or guidelines pooled it, 936 citations in OpenAlex.

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  8. Prognosis of idiopathic pulmonary fibrosis without anti-fibrotic therapy: a systematic review.European respiratory review : an official journal of the European Respiratory Society · 2020
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347 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 7 institutions in 2 countries.

H TaniguchiDept of Respiratory Medicine, Tosei General Hospital, Aichi, Japan.
M Ebina
Y Kondoh
T Ogura
A Azuma
M Suga
Y Taguchi
H Takahashi
K Nakata
A Sato
M Takeuchi
G Raghu
S Kudoh
T Nukiwa
Pirfenidone Clinical Study Group in Japan
Tohoku University · JPKyoto Medical Center · JPNippon Medical School · JPKitasato University · JPSaiseikai Kumamoto Hospital · JPTenri Hospital · JPUniversity of Washington Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease without proven effective therapy. A multicentre, double-blind, placebo-controlled, randomised phase III clinical trial was conducted in Japanese patients with well-defined IPF to determine the efficacy and safety of pirfenidone, a novel antifibrotic oral agent, over 52 weeks. Of 275 patients randomised (high-dose, 1,800 mg x day(-1); low-dose, 1,200 mg x day(-1); or placebo groups in the ratio 2:1:2), 267 patients were evaluated for the efficacy of pirfenidone. Prior to unblinding, the primary end-point was revised; the change in vital capacity (VC) was assessed at week 52. Secondary end-points included the progression-free survival (PFS) time. Significant differences were observed in VC decline (primary end-point) between the placebo group (-0.16 L) and the high-dose group (-0.09 L) (p = 0.0416); differences between the two groups (p = 0.0280) were also observed in the PFS (the secondary end-point). Although photosensitivity, a well-established side-effect of pirfenidone, was the major adverse event in this study, it was mild in severity in most of the patients. Pirfenidone was relatively well tolerated in patients with IPF. Treatment with pirfenidone may decrease the rate of decline in VC and may increase the PFS time over 52 weeks. Additional studies are needed to confirm these findings.

Indexed as

AdultAgedAnti-Inflammatory Agents, Non-SteroidalDisease-Free SurvivalFemaleHumansIdiopathic Pulmonary FibrosisMaleMiddle AgedOximetryPatient CompliancePlacebo EffectPyridonesTreatment OutcomeVital CapacityYoung AdultAnti-Inflammatory Agents, Non-SteroidalpirfenidonePyridones

Identifiers

PMID19996196
OpenAlexW4296612182

What OpenQuestion holds

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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.