Safety, tolerability and appropriate use of nintedanib in idiopathic pulmonary fibrosis.
Identifieur interne : 002692 ( PubMed/Checkpoint ); précédent : 002691; suivant : 002693Safety, tolerability and appropriate use of nintedanib in idiopathic pulmonary fibrosis.
Auteurs : Tamera Corte [Australie] ; Francesco Bonella [Allemagne] ; Bruno Crestani [France] ; Maurits G. Demedts [Belgique] ; Luca Richeldi [Royaume-Uni] ; Carl Coeck [Belgique] ; Katy Pelling [Royaume-Uni] ; Manuel Quaresma [Allemagne] ; Joseph A. Lasky [États-Unis]Source :
- Respiratory research [ 1465-993X ] ; 2015.
Descripteurs français
- KwdFr :
- Adulte d'âge moyen, Calendrier d'administration des médicaments, Diarrhée (), Essais cliniques de phase III comme sujet, Essais contrôlés randomisés comme sujet, Facteurs de risque, Facteurs temps, Femelle, Fibrose pulmonaire idiopathique (diagnostic), Fibrose pulmonaire idiopathique (enzymologie), Fibrose pulmonaire idiopathique (physiopathologie), Fibrose pulmonaire idiopathique (traitement médicamenteux), Humains, Indoles (administration et posologie), Indoles (effets indésirables), Inhibiteurs de protéines kinases (administration et posologie), Inhibiteurs de protéines kinases (effets indésirables), Mâle, Poumon (), Poumon (enzymologie), Poumon (physiopathologie), Résultat thérapeutique, Sujet âgé, Évaluation des risques.
- MESH :
- administration et posologie : Indoles, Inhibiteurs de protéines kinases.
- diagnostic : Fibrose pulmonaire idiopathique.
- effets indésirables : Indoles, Inhibiteurs de protéines kinases.
- enzymologie : Fibrose pulmonaire idiopathique, Poumon.
- physiopathologie : Fibrose pulmonaire idiopathique, Poumon.
- traitement médicamenteux : Fibrose pulmonaire idiopathique.
- Adulte d'âge moyen, Calendrier d'administration des médicaments, Diarrhée, Essais cliniques de phase III comme sujet, Essais contrôlés randomisés comme sujet, Facteurs de risque, Facteurs temps, Femelle, Humains, Mâle, Poumon, Résultat thérapeutique, Sujet âgé, Évaluation des risques.
English descriptors
- KwdEn :
- Aged, Clinical Trials, Phase III as Topic, Diarrhea (chemically induced), Drug Administration Schedule, Female, Humans, Idiopathic Pulmonary Fibrosis (diagnosis), Idiopathic Pulmonary Fibrosis (drug therapy), Idiopathic Pulmonary Fibrosis (enzymology), Idiopathic Pulmonary Fibrosis (physiopathology), Indoles (administration & dosage), Indoles (adverse effects), Lung (drug effects), Lung (enzymology), Lung (physiopathology), Male, Middle Aged, Protein Kinase Inhibitors (administration & dosage), Protein Kinase Inhibitors (adverse effects), Randomized Controlled Trials as Topic, Risk Assessment, Risk Factors, Time Factors, Treatment Outcome.
- MESH :
- chemical , administration & dosage : Indoles, Protein Kinase Inhibitors.
- chemical , adverse effects : Indoles, Protein Kinase Inhibitors.
- chemically induced : Diarrhea.
- diagnosis : Idiopathic Pulmonary Fibrosis.
- drug effects : Lung.
- drug therapy : Idiopathic Pulmonary Fibrosis.
- enzymology : Idiopathic Pulmonary Fibrosis, Lung.
- physiopathology : Idiopathic Pulmonary Fibrosis, Lung.
- Aged, Clinical Trials, Phase III as Topic, Drug Administration Schedule, Female, Humans, Male, Middle Aged, Randomized Controlled Trials as Topic, Risk Assessment, Risk Factors, Time Factors, Treatment Outcome.
Abstract
Idiopathic pulmonary fibrosis (IPF) is a progressive disease characterised by dyspnea and loss of lung function.
DOI: 10.1186/s12931-015-0276-5
PubMed: 26400368
Affiliations:
- Allemagne, Australie, Belgique, France, Royaume-Uni, États-Unis
- Louisiane, Région de Bruxelles-Capitale, Île-de-France
- Bruxelles, Paris
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pubmed:26400368Le document en format XML
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KG, Ingelheim am Rhein, Germany. manuel.quaresma@boehringer-ingelheim.com.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein</wicri:regionArea><wicri:noRegion>Ingelheim am Rhein</wicri:noRegion><wicri:noRegion>Ingelheim am Rhein</wicri:noRegion><wicri:noRegion>Ingelheim am Rhein</wicri:noRegion></affiliation></author><author><name sortKey="Lasky, Joseph A" sort="Lasky, Joseph A" uniqKey="Lasky J" first="Joseph A" last="Lasky">Joseph A. 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pulmonaire idiopathique (enzymologie)</term><term>Fibrose pulmonaire idiopathique (physiopathologie)</term><term>Fibrose pulmonaire idiopathique (traitement médicamenteux)</term><term>Humains</term><term>Indoles (administration et posologie)</term><term>Indoles (effets indésirables)</term><term>Inhibiteurs de protéines kinases (administration et posologie)</term><term>Inhibiteurs de protéines kinases (effets indésirables)</term><term>Mâle</term><term>Poumon ()</term><term>Poumon (enzymologie)</term><term>Poumon (physiopathologie)</term><term>Résultat thérapeutique</term><term>Sujet âgé</term><term>Évaluation des risques</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Indoles</term><term>Protein Kinase Inhibitors</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Indoles</term><term>Protein Kinase Inhibitors</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Indoles</term><term>Inhibiteurs de protéines kinases</term></keywords><keywords scheme="MESH" qualifier="chemically induced" xml:lang="en"><term>Diarrhea</term></keywords><keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Idiopathic Pulmonary Fibrosis</term></keywords><keywords scheme="MESH" qualifier="diagnostic" xml:lang="fr"><term>Fibrose pulmonaire idiopathique</term></keywords><keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>Lung</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Idiopathic Pulmonary Fibrosis</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Indoles</term><term>Inhibiteurs de protéines kinases</term></keywords><keywords scheme="MESH" qualifier="enzymologie" xml:lang="fr"><term>Fibrose pulmonaire idiopathique</term><term>Poumon</term></keywords><keywords scheme="MESH" qualifier="enzymology" xml:lang="en"><term>Idiopathic Pulmonary Fibrosis</term><term>Lung</term></keywords><keywords scheme="MESH" qualifier="physiopathologie" xml:lang="fr"><term>Fibrose pulmonaire idiopathique</term><term>Poumon</term></keywords><keywords scheme="MESH" qualifier="physiopathology" xml:lang="en"><term>Idiopathic Pulmonary Fibrosis</term><term>Lung</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Fibrose pulmonaire idiopathique</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Aged</term><term>Clinical Trials, Phase III as Topic</term><term>Drug Administration Schedule</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Randomized Controlled Trials as Topic</term><term>Risk Assessment</term><term>Risk Factors</term><term>Time Factors</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte d'âge moyen</term><term>Calendrier d'administration des médicaments</term><term>Diarrhée</term><term>Essais cliniques de phase III comme sujet</term><term>Essais contrôlés randomisés comme sujet</term><term>Facteurs de risque</term><term>Facteurs temps</term><term>Femelle</term><term>Humains</term><term>Mâle</term><term>Poumon</term><term>Résultat thérapeutique</term><term>Sujet âgé</term><term>Évaluation des risques</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Idiopathic pulmonary fibrosis (IPF) is a progressive disease characterised by dyspnea and loss of lung function.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">26400368</PMID><DateCreated><Year>2015</Year><Month>09</Month><Day>24</Day></DateCreated><DateCompleted><Year>2016</Year><Month>07</Month><Day>12</Day></DateCompleted><DateRevised><Year>2017</Year><Month>02</Month><Day>20</Day></DateRevised><Article PubModel="Electronic"><Journal><ISSN IssnType="Electronic">1465-993X</ISSN><JournalIssue CitedMedium="Internet"><Volume>16</Volume><PubDate><Year>2015</Year><Month>Sep</Month><Day>24</Day></PubDate></JournalIssue><Title>Respiratory research</Title><ISOAbbreviation>Respir. Res.</ISOAbbreviation></Journal><ArticleTitle>Safety, tolerability and appropriate use of nintedanib in idiopathic pulmonary fibrosis.</ArticleTitle><Pagination><MedlinePgn>116</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1186/s12931-015-0276-5</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Idiopathic pulmonary fibrosis (IPF) is a progressive disease characterised by dyspnea and loss of lung function.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">Using pooled data from the replicate, randomized, 52-week, placebo-controlled INPULSIS(®) trials, we characterized the safety and tolerability of nintedanib 150 mg twice daily in patients with IPF and described how adverse events were managed during these trials.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">One thousand and sixty- one patients were treated (nintedanib 638; placebo 423). Higher proportions of patients in the nintedanib group than the placebo group had ≥ 1 dose reduction to 100 mg bid (27.9% versus 3.8%) or treatment interruption (23.7% versus 9.9%). Adverse events led to permanent treatment discontinuation in 19.3% and 13.0% of patients in the nintedanib and placebo groups, respectively. Diarrhea was the most frequent adverse event, reported in 62.4% of patients in the nintedanib group versus 18.4% in the placebo group; however, only 4.4% of nintedanib-treated patients discontinued trial medication prematurely due to diarrhea. Monitoring of liver enzymes before and periodically during nintedanib treatment was recommended so that liver enzyme elevations could be managed through dose reduction or treatment interruption.</AbstractText><AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">Nintedanib had a manageable safety and tolerability profile in patients with IPF. Recommendations for adverse event management minimized permanent treatment discontinuations in the INPULSIS(®) trials.</AbstractText><AbstractText Label="TRIAL REGISTRATION" NlmCategory="BACKGROUND">clinicaltrials.gov NCT01335464 and NCT01335477.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Corte</LastName><ForeName>Tamera</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia. tameracorte@mac.com.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>University of Sydney, Sydney, New South Wales, Australia. tameracorte@mac.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bonella</LastName><ForeName>Francesco</ForeName><Initials>F</Initials><AffiliationInfo><Affiliation>Ruhrlandklinik, University Hospital, University of Duisburg-Essen, Essen, Germany. francesco.bonella@ruhrlandklinik.uk-essen.de.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Crestani</LastName><ForeName>Bruno</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>Hôpital Bichat, Pneumologie, Paris, France. bruno.crestani@bch.aphp.fr.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Demedts</LastName><ForeName>Maurits G</ForeName><Initials>MG</Initials><AffiliationInfo><Affiliation>University Hospital Leuven, Leuven, Belgium. maurits.demedts@uz.kuleuven.ac.be.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Richeldi</LastName><ForeName>Luca</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>National Institute for Health Research Southampton Respiratory Biomedical Research Unit and Clinical and Experimental Sciences, University of Southampton, Southampton, UK. l.richeldi@soton.ac.uk.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Coeck</LastName><ForeName>Carl</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>SCS Boehringer Ingelheim Comm.V., Brussels, Belgium. carl.coeck@boehringer-ingelheim.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pelling</LastName><ForeName>Katy</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Boehringer Ingelheim Ltd., Bracknell, UK. katy.pelling@boehringer-ingelheim.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Quaresma</LastName><ForeName>Manuel</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany. manuel.quaresma@boehringer-ingelheim.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lasky</LastName><ForeName>Joseph A</ForeName><Initials>JA</Initials><AffiliationInfo><Affiliation>Tulane University School of Medicine, New Orleans, LA, USA. jlasky@tulane.edu.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT01335464</AccessionNumber><AccessionNumber>NCT01335477</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D017418">Meta-Analysis</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2015</Year><Month>09</Month><Day>24</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Respir Res</MedlineTA><NlmUniqueID>101090633</NlmUniqueID><ISSNLinking>1465-9921</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D007211">Indoles</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D047428">Protein Kinase Inhibitors</NameOfSubstance></Chemical><Chemical><RegistryNumber>G6HRD2P839</RegistryNumber><NameOfSubstance UI="C530716">nintedanib</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>Am J Respir Crit Care Med. 2010 Apr 15;181(8):832-7</RefSource><PMID Version="1">20056903</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Nat Rev Drug Discov. 2010 Dec;9(12):956-70</RefSource><PMID 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Version="1">19581909</PMID></CommentsCorrections></CommentsCorrectionsList><MeshHeadingList><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D017326" MajorTopicYN="N">Clinical Trials, Phase III as Topic</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D003967" MajorTopicYN="N">Diarrhea</DescriptorName><QualifierName UI="Q000139" MajorTopicYN="N">chemically induced</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004334" MajorTopicYN="N">Drug Administration Schedule</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D054990" MajorTopicYN="N">Idiopathic Pulmonary Fibrosis</DescriptorName><QualifierName UI="Q000175" MajorTopicYN="N">diagnosis</QualifierName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName><QualifierName UI="Q000201" MajorTopicYN="N">enzymology</QualifierName><QualifierName UI="Q000503" MajorTopicYN="N">physiopathology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007211" MajorTopicYN="N">Indoles</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008168" MajorTopicYN="N">Lung</DescriptorName><QualifierName UI="Q000187" MajorTopicYN="Y">drug effects</QualifierName><QualifierName UI="Q000201" MajorTopicYN="N">enzymology</QualifierName><QualifierName UI="Q000503" MajorTopicYN="N">physiopathology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D047428" MajorTopicYN="N">Protein Kinase Inhibitors</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D016032" MajorTopicYN="N">Randomized Controlled Trials as Topic</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D018570" MajorTopicYN="N">Risk Assessment</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D012307" MajorTopicYN="N">Risk Factors</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D013997" MajorTopicYN="N">Time Factors</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading></MeshHeadingList><OtherID Source="NLM">PMC4581488</OtherID></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2015</Year><Month>04</Month><Day>20</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2015</Year><Month>09</Month><Day>14</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2015</Year><Month>9</Month><Day>25</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2015</Year><Month>9</Month><Day>25</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2016</Year><Month>7</Month><Day>13</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>epublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">26400368</ArticleId><ArticleId IdType="doi">10.1186/s12931-015-0276-5</ArticleId><ArticleId IdType="pii">10.1186/s12931-015-0276-5</ArticleId><ArticleId 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Demedts</name></noRegion><name sortKey="Coeck, Carl" sort="Coeck, Carl" uniqKey="Coeck C" first="Carl" last="Coeck">Carl Coeck</name></country><country name="Royaume-Uni"><noRegion><name sortKey="Richeldi, Luca" sort="Richeldi, Luca" uniqKey="Richeldi L" first="Luca" last="Richeldi">Luca Richeldi</name></noRegion><name sortKey="Pelling, Katy" sort="Pelling, Katy" uniqKey="Pelling K" first="Katy" last="Pelling">Katy Pelling</name></country><country name="États-Unis"><region name="Louisiane"><name sortKey="Lasky, Joseph A" sort="Lasky, Joseph A" uniqKey="Lasky J" first="Joseph A" last="Lasky">Joseph A. Lasky</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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