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 : 001F10 ( PubMed/Curation ); précédent : 001F09; suivant : 001F11Predictors 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 [Royaume-Uni] ; Friedrich Grimminger [Allemagne] ; Ekkehard Grünig [Allemagne] ; Yigao Huang [République populaire de Chine] ; Pavel Jansa [République tchèque] ; Zhi-Cheng Jing [République populaire de Chine] ; David Kilpatrick [Australie] ; David Langleben [Canada] ; Stephan Rosenkranz [Allemagne] ; Flavia Menezes [Brésil] ; Arno Fritsch [Allemagne] ; Sylvia Nikkho [Allemagne] ; Marc Humbert [France]Source :
- 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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<author><name sortKey="Rosenkranz, Stephan" sort="Rosenkranz, Stephan" uniqKey="Rosenkranz S" first="Stephan" last="Rosenkranz">Stephan Rosenkranz</name>
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<author><name sortKey="Menezes, Flavia" sort="Menezes, Flavia" uniqKey="Menezes F" first="Flavia" last="Menezes">Flavia Menezes</name>
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<author><name sortKey="Nikkho, Sylvia" sort="Nikkho, Sylvia" uniqKey="Nikkho S" first="Sylvia" last="Nikkho">Sylvia Nikkho</name>
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<country xml:lang="fr">France</country>
<wicri:regionArea>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</wicri:regionArea>
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<author><name sortKey="Menezes, Flavia" sort="Menezes, Flavia" uniqKey="Menezes F" first="Flavia" last="Menezes">Flavia Menezes</name>
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<author><name sortKey="Fritsch, Arno" sort="Fritsch, Arno" uniqKey="Fritsch A" first="Arno" last="Fritsch">Arno Fritsch</name>
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<author><name sortKey="Nikkho, Sylvia" sort="Nikkho, Sylvia" uniqKey="Nikkho S" first="Sylvia" last="Nikkho">Sylvia Nikkho</name>
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<wicri:regionArea>Global Clinical Development, Bayer Pharma AG, Berlin</wicri:regionArea>
</affiliation>
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<author><name sortKey="Humbert, Marc" sort="Humbert, Marc" uniqKey="Humbert M" first="Marc" last="Humbert">Marc Humbert</name>
<affiliation wicri:level="1"><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>
<country xml:lang="fr">France</country>
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<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>
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<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>
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<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>
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<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>
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<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>
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<Language>eng</Language>
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