Pirfenidone for idiopathic pulmonary fibrosis: analysis of pooled data from three multinational phase 3 trials.
Identifieur interne : 002353 ( PubMed/Curation ); précédent : 002352; suivant : 002354Pirfenidone for idiopathic pulmonary fibrosis: analysis of pooled data from three multinational phase 3 trials.
Auteurs : Paul W. Noble ; Carlo Albera [Italie] ; Williamson Z. Bradford [États-Unis] ; Ulrich Costabel [Allemagne] ; Roland M. Du Bois [Royaume-Uni] ; Elizabeth A. Fagan [États-Unis] ; Robert S. Fishman [États-Unis] ; Ian Glaspole [Australie] ; Marilyn K. Glassberg [États-Unis] ; Lisa Lancaster [États-Unis] ; David J. Lederer [États-Unis] ; Jonathan A. Leff [États-Unis] ; Steven D. Nathan [États-Unis] ; Carlos A. Pereira [Brésil] ; Jeffrey J. Swigris [États-Unis] ; Dominique Valeyre [France] ; Talmadge E. King [États-Unis]Source :
- The European respiratory journal [ 1399-3003 ] ; 2016.
Descripteurs français
- KwdFr :
- Adulte, Adulte d'âge moyen, Anti-inflammatoires non stéroïdiens (usage thérapeutique), Capacité de diffusion pulmonaire, Capacité vitale, Coopération internationale, Essais cliniques de phase III comme sujet, Essais contrôlés randomisés comme sujet, Femelle, Fibrose pulmonaire idiopathique (physiopathologie), Fibrose pulmonaire idiopathique (traitement médicamenteux), Humains, Mâle, Pyridones (usage thérapeutique), Résultat thérapeutique, Sujet âgé, Sujet âgé de 80 ans ou plus, Volume expiratoire maximal par seconde, Épreuve d'effort, Évolution de la maladie.
- MESH :
- physiopathologie : Fibrose pulmonaire idiopathique.
- traitement médicamenteux : Fibrose pulmonaire idiopathique.
- usage thérapeutique : Anti-inflammatoires non stéroïdiens, Pyridones.
- Adulte, Adulte d'âge moyen, Capacité de diffusion pulmonaire, Capacité vitale, Coopération internationale, Essais cliniques de phase III comme sujet, Essais contrôlés randomisés comme sujet, Femelle, Humains, Mâle, Résultat thérapeutique, Sujet âgé, Sujet âgé de 80 ans ou plus, Volume expiratoire maximal par seconde, Épreuve d'effort, Évolution de la maladie.
English descriptors
- KwdEn :
- Adult, Aged, Aged, 80 and over, Anti-Inflammatory Agents, Non-Steroidal (therapeutic use), Clinical Trials, Phase III as Topic, Disease Progression, Exercise Test, Female, Forced Expiratory Volume, Humans, Idiopathic Pulmonary Fibrosis (drug therapy), Idiopathic Pulmonary Fibrosis (physiopathology), International Cooperation, Male, Middle Aged, Pulmonary Diffusing Capacity, Pyridones (therapeutic use), Randomized Controlled Trials as Topic, Treatment Outcome, Vital Capacity.
- MESH :
- chemical , therapeutic use : Anti-Inflammatory Agents, Non-Steroidal, Pyridones.
- drug therapy : Idiopathic Pulmonary Fibrosis.
- physiopathology : Idiopathic Pulmonary Fibrosis.
- Adult, Aged, Aged, 80 and over, Clinical Trials, Phase III as Topic, Disease Progression, Exercise Test, Female, Forced Expiratory Volume, Humans, International Cooperation, Male, Middle Aged, Pulmonary Diffusing Capacity, Randomized Controlled Trials as Topic, Treatment Outcome, Vital Capacity.
Abstract
Pirfenidone is an antifibrotic agent that has been evaluated in three multinational phase 3 trials in patients with idiopathic pulmonary fibrosis (IPF). We analysed pooled data from the multinational trials to obtain the most precise estimates of the magnitude of treatment effect on measures of disease progression.All patients randomised to pirfenidone 2403 mg·day(-1) or placebo in the CAPACITY or ASCEND studies were included in the analysis. Pooled analyses of outcomes at 1 year were based on the pre-specified end-points and analytic methods described in the ASCEND study protocol.A total of 1247 patients were included in the analysis. At 1 year, pirfenidone reduced the proportion of patients with a ≥10% decline in per cent predicted forced vital capacity or death by 43.8% (95% CI 29.3-55.4%) and increased the proportion of patients with no decline by 59.3% (95% CI 29.0-96.8%). A treatment benefit was also observed for progression-free survival, 6-min walk distance and dyspnoea. Gastrointestinal and skin-related adverse events were more common in the pirfenidone group, but rarely led to discontinuation.Analysis of data from three phase 3 trials demonstrated that treatment with pirfenidone for 1 year resulted in clinically meaningful reductions in disease progression in patients with IPF.
DOI: 10.1183/13993003.00026-2015
PubMed: 26647432
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Paul W. Noble<affiliation><nlm:affiliation>Cedars-Sinai Medical Center, Los Angeles, CA, USA Paul.Noble@cshs.org.</nlm:affiliation><wicri:noCountry code="subField">USA Paul.Noble@cshs.org.</wicri:noCountry></affiliation>Le document en format XML
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Noble</name><affiliation><nlm:affiliation>Cedars-Sinai Medical Center, Los Angeles, CA, USA Paul.Noble@cshs.org.</nlm:affiliation><wicri:noCountry code="subField">USA Paul.Noble@cshs.org.</wicri:noCountry></affiliation></author><author><name sortKey="Albera, Carlo" sort="Albera, Carlo" uniqKey="Albera C" first="Carlo" last="Albera">Carlo Albera</name><affiliation wicri:level="1"><nlm:affiliation>University of Turin, Turin, Italy.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>University of Turin, Turin</wicri:regionArea></affiliation></author><author><name sortKey="Bradford, Williamson Z" sort="Bradford, Williamson Z" uniqKey="Bradford W" first="Williamson Z" last="Bradford">Williamson Z. 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King</name><affiliation wicri:level="1"><nlm:affiliation>University of California, San Francisco, San Francisco, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of California, San Francisco, San Francisco, CA</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2016">2016</date><idno type="RBID">pubmed:26647432</idno><idno type="pmid">26647432</idno><idno type="doi">10.1183/13993003.00026-2015</idno><idno type="wicri:Area/PubMed/Corpus">002399</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">002399</idno><idno type="wicri:Area/PubMed/Curation">002353</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">002353</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Pirfenidone for idiopathic pulmonary fibrosis: analysis of pooled data from three multinational phase 3 trials.</title><author><name sortKey="Noble, Paul W" sort="Noble, Paul W" uniqKey="Noble P" first="Paul W" last="Noble">Paul W. Noble</name><affiliation><nlm:affiliation>Cedars-Sinai Medical Center, Los Angeles, CA, USA Paul.Noble@cshs.org.</nlm:affiliation><wicri:noCountry code="subField">USA Paul.Noble@cshs.org.</wicri:noCountry></affiliation></author><author><name sortKey="Albera, Carlo" sort="Albera, Carlo" uniqKey="Albera C" first="Carlo" last="Albera">Carlo Albera</name><affiliation wicri:level="1"><nlm:affiliation>University of Turin, Turin, Italy.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>University of Turin, Turin</wicri:regionArea></affiliation></author><author><name sortKey="Bradford, Williamson Z" sort="Bradford, Williamson Z" uniqKey="Bradford W" first="Williamson Z" last="Bradford">Williamson Z. Bradford</name><affiliation wicri:level="1"><nlm:affiliation>InterMune Inc., Brisbane, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>InterMune Inc., Brisbane, CA</wicri:regionArea></affiliation></author><author><name sortKey="Costabel, Ulrich" sort="Costabel, Ulrich" uniqKey="Costabel U" first="Ulrich" last="Costabel">Ulrich Costabel</name><affiliation wicri:level="1"><nlm:affiliation>Ruhrlandklinik, University of Duisburg-Essen, Essen, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Ruhrlandklinik, University of Duisburg-Essen, Essen</wicri:regionArea></affiliation></author><author><name sortKey="Du Bois, Roland M" sort="Du Bois, Roland M" uniqKey="Du Bois R" first="Roland M" last="Du Bois">Roland M. Du Bois</name><affiliation wicri:level="1"><nlm:affiliation>Imperial College, London, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Imperial College, London</wicri:regionArea></affiliation></author><author><name sortKey="Fagan, Elizabeth A" sort="Fagan, Elizabeth A" uniqKey="Fagan E" first="Elizabeth A" last="Fagan">Elizabeth A. Fagan</name><affiliation wicri:level="1"><nlm:affiliation>InterMune Inc., Brisbane, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>InterMune Inc., Brisbane, CA</wicri:regionArea></affiliation></author><author><name sortKey="Fishman, Robert S" sort="Fishman, Robert S" uniqKey="Fishman R" first="Robert S" last="Fishman">Robert S. Fishman</name><affiliation wicri:level="1"><nlm:affiliation>InterMune Inc., Brisbane, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>InterMune Inc., Brisbane, CA</wicri:regionArea></affiliation></author><author><name sortKey="Glaspole, Ian" sort="Glaspole, Ian" uniqKey="Glaspole I" first="Ian" last="Glaspole">Ian Glaspole</name><affiliation wicri:level="1"><nlm:affiliation>Alfred Hospital and Monash University, Melbourne, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Alfred Hospital and Monash University, Melbourne</wicri:regionArea></affiliation></author><author><name sortKey="Glassberg, Marilyn K" sort="Glassberg, Marilyn K" uniqKey="Glassberg M" first="Marilyn K" last="Glassberg">Marilyn K. Glassberg</name><affiliation wicri:level="1"><nlm:affiliation>University of Miami Miller School of Medicine, Miami, FL, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Miami Miller School of Medicine, Miami, FL</wicri:regionArea></affiliation></author><author><name sortKey="Lancaster, Lisa" sort="Lancaster, Lisa" uniqKey="Lancaster L" first="Lisa" last="Lancaster">Lisa Lancaster</name><affiliation wicri:level="1"><nlm:affiliation>Vanderbilt University Medical Center, Nashville, TN, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Vanderbilt University Medical Center, Nashville, TN</wicri:regionArea></affiliation></author><author><name sortKey="Lederer, David J" sort="Lederer, David J" uniqKey="Lederer D" first="David J" last="Lederer">David J. Lederer</name><affiliation wicri:level="1"><nlm:affiliation>Columbia University Medical Center, New York, NY, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Columbia University Medical Center, New York, NY</wicri:regionArea></affiliation></author><author><name sortKey="Leff, Jonathan A" sort="Leff, Jonathan A" uniqKey="Leff J" first="Jonathan A" last="Leff">Jonathan A. Leff</name><affiliation wicri:level="1"><nlm:affiliation>InterMune Inc., Brisbane, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>InterMune Inc., Brisbane, CA</wicri:regionArea></affiliation></author><author><name sortKey="Nathan, Steven D" sort="Nathan, Steven D" uniqKey="Nathan S" first="Steven D" last="Nathan">Steven D. Nathan</name><affiliation wicri:level="1"><nlm:affiliation>Inova Fairfax Hospital, Falls Church, VA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Inova Fairfax Hospital, Falls Church, VA</wicri:regionArea></affiliation></author><author><name sortKey="Pereira, Carlos A" sort="Pereira, Carlos A" uniqKey="Pereira C" first="Carlos A" last="Pereira">Carlos A. Pereira</name><affiliation wicri:level="1"><nlm:affiliation>Paulista School of Medicine, Federal University of São Paulo, São Paulo, Brazil.</nlm:affiliation><country xml:lang="fr">Brésil</country><wicri:regionArea>Paulista School of Medicine, Federal University of São Paulo, São Paulo</wicri:regionArea></affiliation></author><author><name sortKey="Swigris, Jeffrey J" sort="Swigris, Jeffrey J" uniqKey="Swigris J" first="Jeffrey J" last="Swigris">Jeffrey J. Swigris</name><affiliation wicri:level="1"><nlm:affiliation>National Jewish Health, Denver, CO, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>National Jewish Health, Denver, CO</wicri:regionArea></affiliation></author><author><name sortKey="Valeyre, Dominique" sort="Valeyre, Dominique" uniqKey="Valeyre D" first="Dominique" last="Valeyre">Dominique Valeyre</name><affiliation wicri:level="1"><nlm:affiliation>Assistance Publique-Hôpitaux de Paris, Avicenne University Hospital, Bobigny, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Assistance Publique-Hôpitaux de Paris, Avicenne University Hospital, Bobigny</wicri:regionArea></affiliation></author><author><name sortKey="King, Talmadge E" sort="King, Talmadge E" uniqKey="King T" first="Talmadge E" last="King">Talmadge E. King</name><affiliation wicri:level="1"><nlm:affiliation>University of California, San Francisco, San Francisco, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of California, San Francisco, San Francisco, CA</wicri:regionArea></affiliation></author></analytic><series><title level="j">The European respiratory journal</title><idno type="eISSN">1399-3003</idno><imprint><date when="2016" type="published">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Anti-Inflammatory Agents, Non-Steroidal (therapeutic use)</term><term>Clinical Trials, Phase III as Topic</term><term>Disease Progression</term><term>Exercise Test</term><term>Female</term><term>Forced Expiratory Volume</term><term>Humans</term><term>Idiopathic Pulmonary Fibrosis (drug therapy)</term><term>Idiopathic Pulmonary Fibrosis (physiopathology)</term><term>International Cooperation</term><term>Male</term><term>Middle Aged</term><term>Pulmonary Diffusing Capacity</term><term>Pyridones (therapeutic use)</term><term>Randomized Controlled Trials as Topic</term><term>Treatment Outcome</term><term>Vital Capacity</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Anti-inflammatoires non stéroïdiens (usage thérapeutique)</term><term>Capacité de diffusion pulmonaire</term><term>Capacité vitale</term><term>Coopération internationale</term><term>Essais cliniques de phase III comme sujet</term><term>Essais contrôlés randomisés comme sujet</term><term>Femelle</term><term>Fibrose pulmonaire idiopathique (physiopathologie)</term><term>Fibrose pulmonaire idiopathique (traitement médicamenteux)</term><term>Humains</term><term>Mâle</term><term>Pyridones (usage thérapeutique)</term><term>Résultat thérapeutique</term><term>Sujet âgé</term><term>Sujet âgé de 80 ans ou plus</term><term>Volume expiratoire maximal par seconde</term><term>Épreuve d'effort</term><term>Évolution de la maladie</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Anti-Inflammatory Agents, Non-Steroidal</term><term>Pyridones</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Idiopathic Pulmonary Fibrosis</term></keywords><keywords scheme="MESH" qualifier="physiopathologie" xml:lang="fr"><term>Fibrose pulmonaire idiopathique</term></keywords><keywords scheme="MESH" qualifier="physiopathology" xml:lang="en"><term>Idiopathic Pulmonary Fibrosis</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Fibrose pulmonaire idiopathique</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Anti-inflammatoires non stéroïdiens</term><term>Pyridones</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Clinical Trials, Phase III as Topic</term><term>Disease Progression</term><term>Exercise Test</term><term>Female</term><term>Forced Expiratory Volume</term><term>Humans</term><term>International Cooperation</term><term>Male</term><term>Middle Aged</term><term>Pulmonary Diffusing Capacity</term><term>Randomized Controlled Trials as Topic</term><term>Treatment Outcome</term><term>Vital Capacity</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Capacité de diffusion pulmonaire</term><term>Capacité vitale</term><term>Coopération internationale</term><term>Essais cliniques de phase III comme sujet</term><term>Essais contrôlés randomisés comme sujet</term><term>Femelle</term><term>Humains</term><term>Mâle</term><term>Résultat thérapeutique</term><term>Sujet âgé</term><term>Sujet âgé de 80 ans ou plus</term><term>Volume expiratoire maximal par seconde</term><term>Épreuve d'effort</term><term>Évolution de la maladie</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Pirfenidone is an antifibrotic agent that has been evaluated in three multinational phase 3 trials in patients with idiopathic pulmonary fibrosis (IPF). We analysed pooled data from the multinational trials to obtain the most precise estimates of the magnitude of treatment effect on measures of disease progression.All patients randomised to pirfenidone 2403 mg·day(-1) or placebo in the CAPACITY or ASCEND studies were included in the analysis. Pooled analyses of outcomes at 1 year were based on the pre-specified end-points and analytic methods described in the ASCEND study protocol.A total of 1247 patients were included in the analysis. At 1 year, pirfenidone reduced the proportion of patients with a ≥10% decline in per cent predicted forced vital capacity or death by 43.8% (95% CI 29.3-55.4%) and increased the proportion of patients with no decline by 59.3% (95% CI 29.0-96.8%). A treatment benefit was also observed for progression-free survival, 6-min walk distance and dyspnoea. Gastrointestinal and skin-related adverse events were more common in the pirfenidone group, but rarely led to discontinuation.Analysis of data from three phase 3 trials demonstrated that treatment with pirfenidone for 1 year resulted in clinically meaningful reductions in disease progression in patients with IPF.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">26647432</PMID><DateCreated><Year>2016</Year><Month>01</Month><Day>01</Day></DateCreated><DateCompleted><Year>2017</Year><Month>01</Month><Day>10</Day></DateCompleted><DateRevised><Year>2017</Year><Month>01</Month><Day>11</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1399-3003</ISSN><JournalIssue CitedMedium="Internet"><Volume>47</Volume><Issue>1</Issue><PubDate><Year>2016</Year><Month>Jan</Month></PubDate></JournalIssue><Title>The European respiratory journal</Title><ISOAbbreviation>Eur. Respir. J.</ISOAbbreviation></Journal><ArticleTitle>Pirfenidone for idiopathic pulmonary fibrosis: analysis of pooled data from three multinational phase 3 trials.</ArticleTitle><Pagination><MedlinePgn>243-53</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1183/13993003.00026-2015</ELocationID><Abstract><AbstractText>Pirfenidone is an antifibrotic agent that has been evaluated in three multinational phase 3 trials in patients with idiopathic pulmonary fibrosis (IPF). We analysed pooled data from the multinational trials to obtain the most precise estimates of the magnitude of treatment effect on measures of disease progression.All patients randomised to pirfenidone 2403 mg·day(-1) or placebo in the CAPACITY or ASCEND studies were included in the analysis. Pooled analyses of outcomes at 1 year were based on the pre-specified end-points and analytic methods described in the ASCEND study protocol.A total of 1247 patients were included in the analysis. At 1 year, pirfenidone reduced the proportion of patients with a ≥10% decline in per cent predicted forced vital capacity or death by 43.8% (95% CI 29.3-55.4%) and increased the proportion of patients with no decline by 59.3% (95% CI 29.0-96.8%). A treatment benefit was also observed for progression-free survival, 6-min walk distance and dyspnoea. Gastrointestinal and skin-related adverse events were more common in the pirfenidone group, but rarely led to discontinuation.Analysis of data from three phase 3 trials demonstrated that treatment with pirfenidone for 1 year resulted in clinically meaningful reductions in disease progression in patients with IPF.</AbstractText><CopyrightInformation>Copyright ©ERS 2016.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Noble</LastName><ForeName>Paul W</ForeName><Initials>PW</Initials><AffiliationInfo><Affiliation>Cedars-Sinai Medical Center, Los Angeles, CA, USA Paul.Noble@cshs.org.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Albera</LastName><ForeName>Carlo</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>University of Turin, Turin, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bradford</LastName><ForeName>Williamson Z</ForeName><Initials>WZ</Initials><AffiliationInfo><Affiliation>InterMune Inc., Brisbane, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Costabel</LastName><ForeName>Ulrich</ForeName><Initials>U</Initials><AffiliationInfo><Affiliation>Ruhrlandklinik, University of Duisburg-Essen, Essen, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>du Bois</LastName><ForeName>Roland M</ForeName><Initials>RM</Initials><AffiliationInfo><Affiliation>Imperial College, London, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Fagan</LastName><ForeName>Elizabeth A</ForeName><Initials>EA</Initials><AffiliationInfo><Affiliation>InterMune Inc., Brisbane, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Fishman</LastName><ForeName>Robert S</ForeName><Initials>RS</Initials><AffiliationInfo><Affiliation>InterMune Inc., Brisbane, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Glaspole</LastName><ForeName>Ian</ForeName><Initials>I</Initials><AffiliationInfo><Affiliation>Alfred Hospital and Monash University, Melbourne, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Glassberg</LastName><ForeName>Marilyn K</ForeName><Initials>MK</Initials><AffiliationInfo><Affiliation>University of Miami Miller School of Medicine, Miami, FL, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lancaster</LastName><ForeName>Lisa</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Vanderbilt University Medical Center, Nashville, TN, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lederer</LastName><ForeName>David J</ForeName><Initials>DJ</Initials><AffiliationInfo><Affiliation>Columbia University Medical Center, New York, NY, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Leff</LastName><ForeName>Jonathan A</ForeName><Initials>JA</Initials><AffiliationInfo><Affiliation>InterMune Inc., Brisbane, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Nathan</LastName><ForeName>Steven D</ForeName><Initials>SD</Initials><AffiliationInfo><Affiliation>Inova Fairfax Hospital, Falls Church, VA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pereira</LastName><ForeName>Carlos A</ForeName><Initials>CA</Initials><AffiliationInfo><Affiliation>Paulista School of Medicine, Federal University of São Paulo, São Paulo, Brazil.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Swigris</LastName><ForeName>Jeffrey J</ForeName><Initials>JJ</Initials><AffiliationInfo><Affiliation>National Jewish Health, Denver, CO, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Valeyre</LastName><ForeName>Dominique</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Assistance Publique-Hôpitaux de Paris, Avicenne University Hospital, Bobigny, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>King</LastName><ForeName>Talmadge E</ForeName><Initials>TE</Initials><Suffix>Jr</Suffix><AffiliationInfo><Affiliation>University of California, San Francisco, San Francisco, CA, USA.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D017418">Meta-Analysis</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2015</Year><Month>12</Month><Day>02</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Eur Respir J</MedlineTA><NlmUniqueID>8803460</NlmUniqueID><ISSNLinking>0903-1936</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000894">Anti-Inflammatory Agents, Non-Steroidal</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D011728">Pyridones</NameOfSubstance></Chemical><Chemical><RegistryNumber>D7NLD2JX7U</RegistryNumber><NameOfSubstance UI="C093844">pirfenidone</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>Ann Intern Med. 2005 Jun 21;142(12 Pt 1):963-7</RefSource><PMID Version="1">15968010</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Am J Respir Crit Care Med. 2005 May 1;171(9):1040-7</RefSource><PMID Version="1">15665326</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Cochrane Database Syst Rev. 2010;(9):CD003134</RefSource><PMID Version="1">20824834</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>N Engl J Med. 2014 May 29;370(22):2083-92</RefSource><PMID Version="1">24836312</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Clin Trials. 2012 Apr;9(2):176-87</RefSource><PMID Version="1">22273587</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Stat Med. 1999 Jun 15;18(11):1341-54</RefSource><PMID Version="1">10399200</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Control Clin Trials. 1999 Oct;20(5):408-22</RefSource><PMID Version="1">10503801</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Eur Respir J. 2010 Apr;35(4):821-9</RefSource><PMID Version="1">19996196</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Lancet. 2011 May 21;377(9779):1760-9</RefSource><PMID Version="1">21571362</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Am J Respir Crit Care Med. 2011 Mar 15;183(6):788-824</RefSource><PMID Version="1">21471066</PMID></CommentsCorrections><CommentsCorrections RefType="CommentIn"><RefSource>Eur Respir J. 2016 Jan;47(1):27-30</RefSource><PMID Version="1">26721960</PMID></CommentsCorrections></CommentsCorrectionsList><MeshHeadingList><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000369" MajorTopicYN="N">Aged, 80 and over</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000894" MajorTopicYN="N">Anti-Inflammatory Agents, Non-Steroidal</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D017326" MajorTopicYN="N">Clinical Trials, Phase III as Topic</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D018450" MajorTopicYN="N">Disease Progression</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005080" MajorTopicYN="N">Exercise Test</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005541" MajorTopicYN="N">Forced Expiratory Volume</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D054990" MajorTopicYN="N">Idiopathic Pulmonary Fibrosis</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName><QualifierName UI="Q000503" MajorTopicYN="N">physiopathology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007391" MajorTopicYN="N">International Cooperation</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011653" MajorTopicYN="N">Pulmonary Diffusing Capacity</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011728" MajorTopicYN="N">Pyridones</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D016032" MajorTopicYN="N">Randomized Controlled Trials as Topic</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D014797" MajorTopicYN="N">Vital Capacity</DescriptorName></MeshHeading></MeshHeadingList><OtherID Source="NLM">PMC4697914</OtherID></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2015</Year><Month>01</Month><Day>08</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2015</Year><Month>09</Month><Day>01</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2015</Year><Month>12</Month><Day>10</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate 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