Effect of pirfenidone on mortality: pooled analyses and meta-analyses of clinical trials in idiopathic pulmonary fibrosis.
Identifieur interne : 001249 ( PubMed/Corpus ); précédent : 001248; suivant : 001250Effect of pirfenidone on mortality: pooled analyses and meta-analyses of clinical trials in idiopathic pulmonary fibrosis.
Auteurs : Steven D. Nathan ; Carlo Albera ; Williamson Z. Bradford ; Ulrich Costabel ; Ian Glaspole ; Marilyn K. Glassberg ; David R. Kardatzke ; Monica Daigl ; Klaus-Uwe Kirchgaessler ; Lisa H. Lancaster ; David J. Lederer ; Carlos A. Pereira ; Jeffrey J. Swigris ; Dominique Valeyre ; Paul W. NobleSource :
- The Lancet. Respiratory medicine [ 2213-2619 ] ; 2017.
Abstract
In clinical trials of idiopathic pulmonary fibrosis, rates of all-cause mortality are low. Thus prospective mortality trials are logistically very challenging, justifying the use of pooled analyses or meta-analyses. We did pooled analyses and meta-analyses of clinical trials of pirfenidone versus placebo to determine the effect of pirfenidone on mortality outcomes over 120 weeks.
DOI: 10.1016/S2213-2600(16)30326-5
PubMed: 27876247
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Effect of pirfenidone on mortality: pooled analyses and meta-analyses of clinical trials in idiopathic pulmonary fibrosis.</title><author><name sortKey="Nathan, Steven D" sort="Nathan, Steven D" uniqKey="Nathan S" first="Steven D" last="Nathan">Steven D. Nathan</name><affiliation><nlm:affiliation>Inova Fairfax Hospital, Falls Church, VA, USA. Electronic address: steven.nathan@inova.org.</nlm:affiliation></affiliation></author><author><name sortKey="Albera, Carlo" sort="Albera, Carlo" uniqKey="Albera C" first="Carlo" last="Albera">Carlo Albera</name><affiliation><nlm:affiliation>University of Turin, Turin, Italy.</nlm:affiliation></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><nlm:affiliation>Intermune, Brisbane, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Costabel, Ulrich" sort="Costabel, Ulrich" uniqKey="Costabel U" first="Ulrich" last="Costabel">Ulrich Costabel</name><affiliation><nlm:affiliation>Ruhrlandklinik, University Hospital, University of Duisburg-Essen, Essen, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Glaspole, Ian" sort="Glaspole, Ian" uniqKey="Glaspole I" first="Ian" last="Glaspole">Ian Glaspole</name><affiliation><nlm:affiliation>Alfred Hospital and Monash University, Melbourne, VIC, Australia.</nlm:affiliation></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><nlm:affiliation>University of Miami Miller School of Medicine, Miami, FL, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Kardatzke, David R" sort="Kardatzke, David R" uniqKey="Kardatzke D" first="David R" last="Kardatzke">David R. Kardatzke</name><affiliation><nlm:affiliation>Genentech, South San Francisco, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Daigl, Monica" sort="Daigl, Monica" uniqKey="Daigl M" first="Monica" last="Daigl">Monica Daigl</name><affiliation><nlm:affiliation>F Hoffmann-La Roche, Basel, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Kirchgaessler, Klaus Uwe" sort="Kirchgaessler, Klaus Uwe" uniqKey="Kirchgaessler K" first="Klaus-Uwe" last="Kirchgaessler">Klaus-Uwe Kirchgaessler</name><affiliation><nlm:affiliation>F Hoffmann-La Roche, Basel, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Lancaster, Lisa H" sort="Lancaster, Lisa H" uniqKey="Lancaster L" first="Lisa H" last="Lancaster">Lisa H. Lancaster</name><affiliation><nlm:affiliation>Vanderbilt University Medical Center, Nashville, TN, USA.</nlm:affiliation></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><nlm:affiliation>Columbia University Medical Center, New York, NY, USA.</nlm:affiliation></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><nlm:affiliation>Paulista School of Medicine, Federal University of São Paulo, São Paulo, Brazil.</nlm:affiliation></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><nlm:affiliation>National Jewish Health, Denver, CO, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Valeyre, Dominique" sort="Valeyre, Dominique" uniqKey="Valeyre D" first="Dominique" last="Valeyre">Dominique Valeyre</name><affiliation><nlm:affiliation>Assistance Publique-Hôpitaux de Paris, Avicenne Hospital University, Bobigny, France.</nlm:affiliation></affiliation></author><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.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2017">2017</date><idno type="RBID">pubmed:27876247</idno><idno type="pmid">27876247</idno><idno type="doi">10.1016/S2213-2600(16)30326-5</idno><idno type="wicri:Area/PubMed/Corpus">001249</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">001249</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Effect of pirfenidone on mortality: pooled analyses and meta-analyses of clinical trials in idiopathic pulmonary fibrosis.</title><author><name sortKey="Nathan, Steven D" sort="Nathan, Steven D" uniqKey="Nathan S" first="Steven D" last="Nathan">Steven D. Nathan</name><affiliation><nlm:affiliation>Inova Fairfax Hospital, Falls Church, VA, USA. Electronic address: steven.nathan@inova.org.</nlm:affiliation></affiliation></author><author><name sortKey="Albera, Carlo" sort="Albera, Carlo" uniqKey="Albera C" first="Carlo" last="Albera">Carlo Albera</name><affiliation><nlm:affiliation>University of Turin, Turin, Italy.</nlm:affiliation></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><nlm:affiliation>Intermune, Brisbane, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Costabel, Ulrich" sort="Costabel, Ulrich" uniqKey="Costabel U" first="Ulrich" last="Costabel">Ulrich Costabel</name><affiliation><nlm:affiliation>Ruhrlandklinik, University Hospital, University of Duisburg-Essen, Essen, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Glaspole, Ian" sort="Glaspole, Ian" uniqKey="Glaspole I" first="Ian" last="Glaspole">Ian Glaspole</name><affiliation><nlm:affiliation>Alfred Hospital and Monash University, Melbourne, VIC, Australia.</nlm:affiliation></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><nlm:affiliation>University of Miami Miller School of Medicine, Miami, FL, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Kardatzke, David R" sort="Kardatzke, David R" uniqKey="Kardatzke D" first="David R" last="Kardatzke">David R. Kardatzke</name><affiliation><nlm:affiliation>Genentech, South San Francisco, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Daigl, Monica" sort="Daigl, Monica" uniqKey="Daigl M" first="Monica" last="Daigl">Monica Daigl</name><affiliation><nlm:affiliation>F Hoffmann-La Roche, Basel, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Kirchgaessler, Klaus Uwe" sort="Kirchgaessler, Klaus Uwe" uniqKey="Kirchgaessler K" first="Klaus-Uwe" last="Kirchgaessler">Klaus-Uwe Kirchgaessler</name><affiliation><nlm:affiliation>F Hoffmann-La Roche, Basel, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Lancaster, Lisa H" sort="Lancaster, Lisa H" uniqKey="Lancaster L" first="Lisa H" last="Lancaster">Lisa H. Lancaster</name><affiliation><nlm:affiliation>Vanderbilt University Medical Center, Nashville, TN, USA.</nlm:affiliation></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><nlm:affiliation>Columbia University Medical Center, New York, NY, USA.</nlm:affiliation></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><nlm:affiliation>Paulista School of Medicine, Federal University of São Paulo, São Paulo, Brazil.</nlm:affiliation></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><nlm:affiliation>National Jewish Health, Denver, CO, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Valeyre, Dominique" sort="Valeyre, Dominique" uniqKey="Valeyre D" first="Dominique" last="Valeyre">Dominique Valeyre</name><affiliation><nlm:affiliation>Assistance Publique-Hôpitaux de Paris, Avicenne Hospital University, Bobigny, France.</nlm:affiliation></affiliation></author><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.</nlm:affiliation></affiliation></author></analytic><series><title level="j">The Lancet. Respiratory medicine</title><idno type="eISSN">2213-2619</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">In clinical trials of idiopathic pulmonary fibrosis, rates of all-cause mortality are low. Thus prospective mortality trials are logistically very challenging, justifying the use of pooled analyses or meta-analyses. We did pooled analyses and meta-analyses of clinical trials of pirfenidone versus placebo to determine the effect of pirfenidone on mortality outcomes over 120 weeks.</div></front></TEI><pubmed><MedlineCitation Status="In-Process" Owner="NLM"><PMID Version="1">27876247</PMID><DateCreated><Year>2016</Year><Month>11</Month><Day>23</Day></DateCreated><DateRevised><Year>2016</Year><Month>12</Month><Day>21</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">2213-2619</ISSN><JournalIssue CitedMedium="Internet"><Volume>5</Volume><Issue>1</Issue><PubDate><Year>2017</Year><Month>Jan</Month></PubDate></JournalIssue><Title>The Lancet. Respiratory medicine</Title><ISOAbbreviation>Lancet Respir Med</ISOAbbreviation></Journal><ArticleTitle>Effect of pirfenidone on mortality: pooled analyses and meta-analyses of clinical trials in idiopathic pulmonary fibrosis.</ArticleTitle><Pagination><MedlinePgn>33-41</MedlinePgn></Pagination><ELocationID EIdType="pii" ValidYN="Y">S2213-2600(16)30326-5</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/S2213-2600(16)30326-5</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">In clinical trials of idiopathic pulmonary fibrosis, rates of all-cause mortality are low. Thus prospective mortality trials are logistically very challenging, justifying the use of pooled analyses or meta-analyses. We did pooled analyses and meta-analyses of clinical trials of pirfenidone versus placebo to determine the effect of pirfenidone on mortality outcomes over 120 weeks.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">We did a pooled analysis of the combined patient populations of the three global randomised phase 3 trials of pirfenidone versus placebo-Clinical Studies Assessing Pirfenidone in Idiopathic Pulmonary Fibrosis: Research of Efficacy and Safety Outcomes (CAPACITY 004 and 006; trial durations 72-120 weeks) and Assessment of Pirfenidone to Confirm Efficacy and Safety in Idiopathic Pulmonary Fibrosis (ASCEND 016; 52 weeks)-for all-cause mortality, treatment-emergent all-cause mortality, idiopathic-pulmonary-fibrosis-related mortality, and treatment-emergent idiopathic-pulmonary-fibrosis-related mortality at weeks 52, 72, and 120. We also did meta-analyses of these data and data from two Japanese trials of pirfenidone versus placebo-Shionogi Phase 2 (SP2) and Shionogi Phase 3 (SP3; trial durations 36-52 weeks).</AbstractText><AbstractText Label="FINDINGS" NlmCategory="RESULTS">At week 52, the relative risk of death for all four mortality outcomes was significantly lower in the pirfenidone group than in the placebo group in the pooled population (all-cause mortality hazard ratio [HR] 0·52 [95% CI 0·31-0·87; p=0·0107]; treatment-emergent all-cause mortality 0·45 [0·24-0·83; 0·0094]; idiopathic-pulmonary-fibrosis-related mortality 0·35 [0·17-0·72; 0·0029]; treatment-emergent idiopathic-pulmonary-fibrosis-related mortality 0·32 [0·14-0·76; 0·0061]). Consistent with the pooled analysis, meta-analyses for all-cause mortality at week 52 also showed a clinically relevant and significant risk reduction in the pirfenidone group compared with the placebo group. Over 120 weeks, we noted significant differences in the pooled analysis favouring pirfenidone therapy compared with placebo for treatment-emergent all-cause mortality (p=0·0420), idiopathic-pulmonary-fibrosis-related mortality (0·0237), and treatment-emergent idiopathic-pulmonary-fibrosis-related (0·0132) mortality; similar results were shown by meta-analyses.</AbstractText><AbstractText Label="INTERPRETATION" NlmCategory="CONCLUSIONS">Several analytic approaches demonstrated that pirfenidone therapy is associated with a reduction in the relative risk of mortality compared with placebo over 120 weeks.</AbstractText><AbstractText Label="FUNDING" NlmCategory="BACKGROUND">F Hoffmann-La Roche/Genentech.</AbstractText><CopyrightInformation>Copyright © 2017 Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Nathan</LastName><ForeName>Steven D</ForeName><Initials>SD</Initials><AffiliationInfo><Affiliation>Inova Fairfax Hospital, Falls Church, VA, USA. Electronic address: steven.nathan@inova.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, Brisbane, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Costabel</LastName><ForeName>Ulrich</ForeName><Initials>U</Initials><AffiliationInfo><Affiliation>Ruhrlandklinik, University Hospital, University of Duisburg-Essen, Essen, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Glaspole</LastName><ForeName>Ian</ForeName><Initials>I</Initials><AffiliationInfo><Affiliation>Alfred Hospital and Monash University, Melbourne, VIC, 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>Kardatzke</LastName><ForeName>David R</ForeName><Initials>DR</Initials><AffiliationInfo><Affiliation>Genentech, South San Francisco, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Daigl</LastName><ForeName>Monica</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>F Hoffmann-La Roche, Basel, Switzerland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kirchgaessler</LastName><ForeName>Klaus-Uwe</ForeName><Initials>KU</Initials><AffiliationInfo><Affiliation>F Hoffmann-La Roche, Basel, Switzerland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lancaster</LastName><ForeName>Lisa H</ForeName><Initials>LH</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>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 Hospital University, Bobigny, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Noble</LastName><ForeName>Paul W</ForeName><Initials>PW</Initials><AffiliationInfo><Affiliation>Cedars Sinai Medical Center, Los Angeles, CA, USA.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2016</Year><Month>11</Month><Day>19</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Lancet Respir Med</MedlineTA><NlmUniqueID>101605555</NlmUniqueID><ISSNLinking>2213-2600</ISSNLinking></MedlineJournalInfo></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2016</Year><Month>06</Month><Day>01</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2016</Year><Month>09</Month><Day>29</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2016</Year><Month>09</Month><Day>29</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2016</Year><Month>11</Month><Day>24</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2016</Year><Month>11</Month><Day>24</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2016</Year><Month>11</Month><Day>24</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">27876247</ArticleId><ArticleId IdType="pii">S2213-2600(16)30326-5</ArticleId><ArticleId IdType="doi">10.1016/S2213-2600(16)30326-5</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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