Predictors of long-term outcomes in patients treated with riociguat for pulmonary arterial hypertension: data from the PATENT-2 open-label, randomised, long-term extension trial.
Identifieur interne : 001F34 ( PubMed/Corpus ); précédent : 001F33; suivant : 001F35Predictors of long-term outcomes in patients treated with riociguat for pulmonary arterial hypertension: data from the PATENT-2 open-label, randomised, long-term extension trial.
Auteurs : Hossein-Ardeschir Ghofrani ; Friedrich Grimminger ; Ekkehard Grünig ; Yigao Huang ; Pavel Jansa ; Zhi-Cheng Jing ; David Kilpatrick ; David Langleben ; Stephan Rosenkranz ; Flavia Menezes ; Arno Fritsch ; Sylvia Nikkho ; Marc HumbertSource :
- The Lancet. Respiratory medicine [ 2213-2619 ] ; 2016.
Abstract
Pulmonary arterial hypertension is a chronic disease associated with poor long-term outcomes. Identifying predictors of long-term outcome in pulmonary arterial hypertension is important to assess disease severity and guide treatment. We investigate associations between efficacy parameters and long-term outcomes in patients with pulmonary arterial hypertension receiving riociguat in the PATENT-2 study. We also present safety and efficacy data from the final data cutoff of PATENT-2, where most patients had received at least 2 years of riociguat treatment.
DOI: 10.1016/S2213-2600(16)30019-4
PubMed: 27067479
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Predictors of long-term outcomes in patients treated with riociguat for pulmonary arterial hypertension: data from the PATENT-2 open-label, randomised, long-term extension trial.</title><author><name sortKey="Ghofrani, Hossein Ardeschir" sort="Ghofrani, Hossein Ardeschir" uniqKey="Ghofrani H" first="Hossein-Ardeschir" last="Ghofrani">Hossein-Ardeschir Ghofrani</name><affiliation><nlm:affiliation>University of Giessen and Marburg Lung Center (UGMLC) and German Centre of Lung Research (DZL), Giessen, Germany; Department of Medicine, Imperial College London, London, UK. Electronic address: Ardeschir.Ghofrani@innere.med.uni-giessen.de.</nlm:affiliation></affiliation></author><author><name sortKey="Grimminger, Friedrich" sort="Grimminger, Friedrich" uniqKey="Grimminger F" first="Friedrich" last="Grimminger">Friedrich Grimminger</name><affiliation><nlm:affiliation>University of Giessen and Marburg Lung Center (UGMLC) and German Centre of Lung Research (DZL), Giessen, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Grunig, Ekkehard" sort="Grunig, Ekkehard" uniqKey="Grunig E" first="Ekkehard" last="Grünig">Ekkehard Grünig</name><affiliation><nlm:affiliation>Centre for Pulmonary Hypertension at the Thoraxclinic of University Hospital Heidelberg, Heidelberg, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Huang, Yigao" sort="Huang, Yigao" uniqKey="Huang Y" first="Yigao" last="Huang">Yigao Huang</name><affiliation><nlm:affiliation>Department of Cardiology, Guangdong General Hospital and Guangdong Cardiovascular Institute, Guangzhou, Guangdong, China.</nlm:affiliation></affiliation></author><author><name sortKey="Jansa, Pavel" sort="Jansa, Pavel" uniqKey="Jansa P" first="Pavel" last="Jansa">Pavel Jansa</name><affiliation><nlm:affiliation>Clinical Department of Cardiology and Angiology of the First Faculty of Medicine and General Teaching Hospital, Prague, Czech Republic.</nlm:affiliation></affiliation></author><author><name sortKey="Jing, Zhi Cheng" sort="Jing, Zhi Cheng" uniqKey="Jing Z" first="Zhi-Cheng" last="Jing">Zhi-Cheng Jing</name><affiliation><nlm:affiliation>State Key Laboratory of Cardiovascular Disease, Fu Wai Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China.</nlm:affiliation></affiliation></author><author><name sortKey="Kilpatrick, David" sort="Kilpatrick, David" uniqKey="Kilpatrick D" first="David" last="Kilpatrick">David Kilpatrick</name><affiliation><nlm:affiliation>Discipline of Medicine, University of Tasmania, Hobart, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Langleben, David" sort="Langleben, David" uniqKey="Langleben D" first="David" last="Langleben">David Langleben</name><affiliation><nlm:affiliation>Center for Pulmonary Vascular Disease and Lady Davis Institute, Jewish General Hospital, McGill University, Montreal, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Rosenkranz, Stephan" sort="Rosenkranz, Stephan" uniqKey="Rosenkranz S" first="Stephan" last="Rosenkranz">Stephan Rosenkranz</name><affiliation><nlm:affiliation>Department III of Internal Medicine and Cologne Cardiovascular Research Center (CCRC), Cologne University Heart Center, Cologne, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Menezes, Flavia" sort="Menezes, Flavia" uniqKey="Menezes F" first="Flavia" last="Menezes">Flavia Menezes</name><affiliation><nlm:affiliation>Bayer HealthCare Pharmaceuticals, São Paulo, Brazil.</nlm:affiliation></affiliation></author><author><name sortKey="Fritsch, Arno" sort="Fritsch, Arno" uniqKey="Fritsch A" first="Arno" last="Fritsch">Arno Fritsch</name><affiliation><nlm:affiliation>Global Clinical Development, Bayer Pharma AG, Wuppertal, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Nikkho, Sylvia" sort="Nikkho, Sylvia" uniqKey="Nikkho S" first="Sylvia" last="Nikkho">Sylvia Nikkho</name><affiliation><nlm:affiliation>Global Clinical Development, Bayer Pharma AG, Berlin, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Humbert, Marc" sort="Humbert, Marc" uniqKey="Humbert M" first="Marc" last="Humbert">Marc Humbert</name><affiliation><nlm:affiliation>Université Paris-Sud, Université Paris-Saclay, Le Kremlin Bicêtre, France; AP-HP, Service de Pneumologie, Hôpital Bicêtre, Le Kremlin Bicêtre, France; Inserm UMR_S 999, Hôpital Marie Lannelongue, Le Plessis Robinson, France.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2016">2016</date><idno type="RBID">pubmed:27067479</idno><idno type="pmid">27067479</idno><idno type="doi">10.1016/S2213-2600(16)30019-4</idno><idno type="wicri:Area/PubMed/Corpus">001F34</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">001F34</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Predictors of long-term outcomes in patients treated with riociguat for pulmonary arterial hypertension: data from the PATENT-2 open-label, randomised, long-term extension trial.</title><author><name sortKey="Ghofrani, Hossein Ardeschir" sort="Ghofrani, Hossein Ardeschir" uniqKey="Ghofrani H" first="Hossein-Ardeschir" last="Ghofrani">Hossein-Ardeschir Ghofrani</name><affiliation><nlm:affiliation>University of Giessen and Marburg Lung Center (UGMLC) and German Centre of Lung Research (DZL), Giessen, Germany; Department of Medicine, Imperial College London, London, UK. Electronic address: Ardeschir.Ghofrani@innere.med.uni-giessen.de.</nlm:affiliation></affiliation></author><author><name sortKey="Grimminger, Friedrich" sort="Grimminger, Friedrich" uniqKey="Grimminger F" first="Friedrich" last="Grimminger">Friedrich Grimminger</name><affiliation><nlm:affiliation>University of Giessen and Marburg Lung Center (UGMLC) and German Centre of Lung Research (DZL), Giessen, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Grunig, Ekkehard" sort="Grunig, Ekkehard" uniqKey="Grunig E" first="Ekkehard" last="Grünig">Ekkehard Grünig</name><affiliation><nlm:affiliation>Centre for Pulmonary Hypertension at the Thoraxclinic of University Hospital Heidelberg, Heidelberg, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Huang, Yigao" sort="Huang, Yigao" uniqKey="Huang Y" first="Yigao" last="Huang">Yigao Huang</name><affiliation><nlm:affiliation>Department of Cardiology, Guangdong General Hospital and Guangdong Cardiovascular Institute, Guangzhou, Guangdong, China.</nlm:affiliation></affiliation></author><author><name sortKey="Jansa, Pavel" sort="Jansa, Pavel" uniqKey="Jansa P" first="Pavel" last="Jansa">Pavel Jansa</name><affiliation><nlm:affiliation>Clinical Department of Cardiology and Angiology of the First Faculty of Medicine and General Teaching Hospital, Prague, Czech Republic.</nlm:affiliation></affiliation></author><author><name sortKey="Jing, Zhi Cheng" sort="Jing, Zhi Cheng" uniqKey="Jing Z" first="Zhi-Cheng" last="Jing">Zhi-Cheng Jing</name><affiliation><nlm:affiliation>State Key Laboratory of Cardiovascular Disease, Fu Wai Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China.</nlm:affiliation></affiliation></author><author><name sortKey="Kilpatrick, David" sort="Kilpatrick, David" uniqKey="Kilpatrick D" first="David" last="Kilpatrick">David Kilpatrick</name><affiliation><nlm:affiliation>Discipline of Medicine, University of Tasmania, Hobart, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Langleben, David" sort="Langleben, David" uniqKey="Langleben D" first="David" last="Langleben">David Langleben</name><affiliation><nlm:affiliation>Center for Pulmonary Vascular Disease and Lady Davis Institute, Jewish General Hospital, McGill University, Montreal, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Rosenkranz, Stephan" sort="Rosenkranz, Stephan" uniqKey="Rosenkranz S" first="Stephan" last="Rosenkranz">Stephan Rosenkranz</name><affiliation><nlm:affiliation>Department III of Internal Medicine and Cologne Cardiovascular Research Center (CCRC), Cologne University Heart Center, Cologne, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Menezes, Flavia" sort="Menezes, Flavia" uniqKey="Menezes F" first="Flavia" last="Menezes">Flavia Menezes</name><affiliation><nlm:affiliation>Bayer HealthCare Pharmaceuticals, São Paulo, Brazil.</nlm:affiliation></affiliation></author><author><name sortKey="Fritsch, Arno" sort="Fritsch, Arno" uniqKey="Fritsch A" first="Arno" last="Fritsch">Arno Fritsch</name><affiliation><nlm:affiliation>Global Clinical Development, Bayer Pharma AG, Wuppertal, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Nikkho, Sylvia" sort="Nikkho, Sylvia" uniqKey="Nikkho S" first="Sylvia" last="Nikkho">Sylvia Nikkho</name><affiliation><nlm:affiliation>Global Clinical Development, Bayer Pharma AG, Berlin, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Humbert, Marc" sort="Humbert, Marc" uniqKey="Humbert M" first="Marc" last="Humbert">Marc Humbert</name><affiliation><nlm:affiliation>Université Paris-Sud, Université Paris-Saclay, Le Kremlin Bicêtre, France; AP-HP, Service de Pneumologie, Hôpital Bicêtre, Le Kremlin Bicêtre, France; Inserm UMR_S 999, Hôpital Marie Lannelongue, Le Plessis Robinson, France.</nlm:affiliation></affiliation></author></analytic><series><title level="j">The Lancet. Respiratory medicine</title><idno type="eISSN">2213-2619</idno><imprint><date when="2016" type="published">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Pulmonary arterial hypertension is a chronic disease associated with poor long-term outcomes. Identifying predictors of long-term outcome in pulmonary arterial hypertension is important to assess disease severity and guide treatment. We investigate associations between efficacy parameters and long-term outcomes in patients with pulmonary arterial hypertension receiving riociguat in the PATENT-2 study. We also present safety and efficacy data from the final data cutoff of PATENT-2, where most patients had received at least 2 years of riociguat treatment.</div></front></TEI><pubmed><MedlineCitation Status="In-Process" Owner="NLM"><PMID Version="1">27067479</PMID><DateCreated><Year>2016</Year><Month>06</Month><Day>16</Day></DateCreated><DateRevised><Year>2017</Year><Month>02</Month><Day>03</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">2213-2619</ISSN><JournalIssue CitedMedium="Internet"><Volume>4</Volume><Issue>5</Issue><PubDate><Year>2016</Year><Month>May</Month></PubDate></JournalIssue><Title>The Lancet. Respiratory medicine</Title><ISOAbbreviation>Lancet Respir Med</ISOAbbreviation></Journal><ArticleTitle>Predictors of long-term outcomes in patients treated with riociguat for pulmonary arterial hypertension: data from the PATENT-2 open-label, randomised, long-term extension trial.</ArticleTitle><Pagination><MedlinePgn>361-71</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1016/S2213-2600(16)30019-4</ELocationID><ELocationID EIdType="pii" ValidYN="Y">S2213-2600(16)30019-4</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Pulmonary arterial hypertension is a chronic disease associated with poor long-term outcomes. Identifying predictors of long-term outcome in pulmonary arterial hypertension is important to assess disease severity and guide treatment. We investigate associations between efficacy parameters and long-term outcomes in patients with pulmonary arterial hypertension receiving riociguat in the PATENT-2 study. We also present safety and efficacy data from the final data cutoff of PATENT-2, where most patients had received at least 2 years of riociguat treatment.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">Eligible patients from the PATENT-1 study entered the PATENT-2 open-label extension, which will continue until all patients transition to the commercial drug. All patients received riociguat individually adjusted to a maximum dose of 2·5 mg three times a day. The primary endpoint was safety and tolerability, assessed with recording adverse events, serious adverse events, discontinuations, and deaths; exploratory assessments included 6-min walking distance (6MWD), WHO functional class, N-terminal prohormone of brain natriuretic peptide (NT-proBNP)concentrations, Borg dyspnoea score, health-related quality of life (EQ-5D score), survival, and clinical worsening-free survival. Association between efficacy parameters and long-term outcomes was assessed using Kaplan-Meier analyses and a Cox proportional-hazards regression model. PATENT-2 is registered at ClinicalTrials.gov, number NCT00863681.</AbstractText><AbstractText Label="FINDINGS" NlmCategory="RESULTS">396 patients entered PATENT-2, of whom 197 patients were receiving riociguat monotherapy and 199 were receiving riociguat in combination with endothelin receptor antagonists or prostanoids, or both. A significant association was noted between 6MWD, NT-proBNP concentration, and WHO functional class and overall survival at baseline (p=0·0006, 0·0225, and 0·0191, respectively), and at follow-up (p=0·021, 0·0056, and 0·0048, respectively). Riociguat was well tolerated in PATENT-2. Serious adverse events were recorded in 238 (60%) of the total population, and 45 (11%) patients discontinued treatment because of an adverse event. Improvements in 6MWD, WHO functional class, and NT-proBNP concentrations were maintained after 2 years of treatment.</AbstractText><AbstractText Label="INTERPRETATION" NlmCategory="CONCLUSIONS">These results support the long-term use of riociguat in patients with pulmonary arterial hypertension, and emphasise the prognostic value of 6MWD, WHO functional class, and NT-proBNP concentrations.</AbstractText><AbstractText Label="FUNDING" NlmCategory="BACKGROUND">Bayer Pharma AG.</AbstractText><CopyrightInformation>Copyright © 2016 Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Ghofrani</LastName><ForeName>Hossein-Ardeschir</ForeName><Initials>HA</Initials><AffiliationInfo><Affiliation>University of Giessen and Marburg Lung Center (UGMLC) and German Centre of Lung Research (DZL), Giessen, Germany; Department of Medicine, Imperial College London, London, UK. Electronic address: Ardeschir.Ghofrani@innere.med.uni-giessen.de.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Grimminger</LastName><ForeName>Friedrich</ForeName><Initials>F</Initials><AffiliationInfo><Affiliation>University of Giessen and Marburg Lung Center (UGMLC) and German Centre of Lung Research (DZL), Giessen, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Grünig</LastName><ForeName>Ekkehard</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>Centre for Pulmonary Hypertension at the Thoraxclinic of University Hospital Heidelberg, Heidelberg, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Huang</LastName><ForeName>Yigao</ForeName><Initials>Y</Initials><AffiliationInfo><Affiliation>Department of Cardiology, Guangdong General Hospital and Guangdong Cardiovascular Institute, Guangzhou, Guangdong, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Jansa</LastName><ForeName>Pavel</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Clinical Department of Cardiology and Angiology of the First Faculty of Medicine and General Teaching Hospital, Prague, Czech Republic.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Jing</LastName><ForeName>Zhi-Cheng</ForeName><Initials>ZC</Initials><AffiliationInfo><Affiliation>State Key Laboratory of Cardiovascular Disease, Fu Wai Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kilpatrick</LastName><ForeName>David</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Discipline of Medicine, University of Tasmania, Hobart, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Langleben</LastName><ForeName>David</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Center for Pulmonary Vascular Disease and Lady Davis Institute, Jewish General Hospital, McGill University, Montreal, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rosenkranz</LastName><ForeName>Stephan</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Department III of Internal Medicine and Cologne Cardiovascular Research Center (CCRC), Cologne University Heart Center, Cologne, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Menezes</LastName><ForeName>Flavia</ForeName><Initials>F</Initials><AffiliationInfo><Affiliation>Bayer HealthCare Pharmaceuticals, São Paulo, Brazil.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Fritsch</LastName><ForeName>Arno</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Global Clinical Development, Bayer Pharma AG, Wuppertal, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Nikkho</LastName><ForeName>Sylvia</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Global Clinical Development, Bayer Pharma AG, Berlin, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Humbert</LastName><ForeName>Marc</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Université Paris-Sud, Université Paris-Saclay, Le Kremlin Bicêtre, France; AP-HP, Service de Pneumologie, Hôpital Bicêtre, Le Kremlin Bicêtre, France; Inserm UMR_S 999, Hôpital Marie Lannelongue, Le Plessis Robinson, France.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT00863681</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2016</Year><Month>04</Month><Day>08</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Lancet Respir Med</MedlineTA><NlmUniqueID>101605555</NlmUniqueID><ISSNLinking>2213-2600</ISSNLinking></MedlineJournalInfo><CitationSubset>IM</CitationSubset></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2016</Year><Month>01</Month><Day>22</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2016</Year><Month>03</Month><Day>15</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2016</Year><Month>03</Month><Day>16</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2016</Year><Month>4</Month><Day>13</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2016</Year><Month>4</Month><Day>14</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2016</Year><Month>4</Month><Day>14</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">27067479</ArticleId><ArticleId IdType="pii">S2213-2600(16)30019-4</ArticleId><ArticleId IdType="doi">10.1016/S2213-2600(16)30019-4</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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