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Use of clinically relevant responder threshold criteria to evaluate the response to treatment in the phase III PATENT-1 study.

Identifieur interne : 002E57 ( PubMed/Curation ); précédent : 002E56; suivant : 002E58

Use of clinically relevant responder threshold criteria to evaluate the response to treatment in the phase III PATENT-1 study.

Auteurs : David Langleben [Canada] ; Nazzareno Galiè [Italie] ; Jianguo He [République populaire de Chine] ; Yigao Huang [République populaire de Chine] ; Marc Humbert [France] ; Anne Keogh [Australie] ; Lewis J. Rubin [États-Unis] ; Daxin Zhou [République populaire de Chine] ; John Curram [Royaume-Uni] ; Neil Davie [Allemagne] ; Hossein-Ardeschir Ghofrani [Royaume-Uni]

Source :

RBID : pubmed:25703961

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English descriptors

Abstract

In PATENT-1, riociguat significantly improved 6-minute walking distance (6MWD) and a range of secondary end-points in patients with pulmonary arterial hypertension (PAH). We investigated whether riociguat increased the proportion of patients achieving clinically relevant responder thresholds compared with placebo during PATENT-1.

DOI: 10.1016/j.healun.2014.12.001
PubMed: 25703961

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pubmed:25703961

Le document en format XML

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<front>
<div type="abstract" xml:lang="en">In PATENT-1, riociguat significantly improved 6-minute walking distance (6MWD) and a range of secondary end-points in patients with pulmonary arterial hypertension (PAH). We investigated whether riociguat increased the proportion of patients achieving clinically relevant responder thresholds compared with placebo during PATENT-1.</div>
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<Month>03</Month>
<Day>27</Day>
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<Year>2015</Year>
<Month>12</Month>
<Day>15</Day>
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<Year>2017</Year>
<Month>11</Month>
<Day>16</Day>
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<ISSN IssnType="Electronic">1557-3117</ISSN>
<JournalIssue CitedMedium="Internet">
<Volume>34</Volume>
<Issue>3</Issue>
<PubDate>
<Year>2015</Year>
<Month>Mar</Month>
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<Title>The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation</Title>
<ISOAbbreviation>J. Heart Lung Transplant.</ISOAbbreviation>
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<ArticleTitle>Use of clinically relevant responder threshold criteria to evaluate the response to treatment in the phase III PATENT-1 study.</ArticleTitle>
<Pagination>
<MedlinePgn>338-47</MedlinePgn>
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<ELocationID EIdType="pii" ValidYN="Y">S1053-2498(14)01496-X</ELocationID>
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<AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">In PATENT-1, riociguat significantly improved 6-minute walking distance (6MWD) and a range of secondary end-points in patients with pulmonary arterial hypertension (PAH). We investigated whether riociguat increased the proportion of patients achieving clinically relevant responder thresholds compared with placebo during PATENT-1.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">In PATENT-1, a randomized, double-blind study, treatment-naïve patients or patients on background PAH-targeted therapy with symptomatic PAH received 12 weeks of treatment with placebo, riociguat up to 2.5 mg 3 times daily, or riociguat up to 1.5 mg 3 times daily. Increases in 6MWD ≥40 m, 6MWD ≥380 m, cardiac index ≥2.5 liter/min/m(2), mixed venous oxygen saturation ≥65%, World Health Organization functional class I/II, N-terminal pro-brain natriuretic peptide <1,800 pg/ml, and right atrial pressure <8 mm Hg were chosen as threshold criteria of a positive response.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">Riociguat increased the proportion of treatment-naïve patients and patients on background PAH-targeted therapy with 6MWD ≥380 m at Week 12 (+21% and +15%, respectively), whereas there was a small reduction in 6MWD in placebo-treated patients for both sub-groups. Riociguat also increased the proportion of treatment-naïve patients and patients on background PAH-targeted therapy achieving World Health Organization functional class I/II (+12% and +19%, respectively) and cardiac index ≥2.5 liter/min/m(2) (+30% and +33%, respectively) at Week 12, whereas there was little change in the respective placebo groups.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Compared with placebo, riociguat increased the proportion of treatment-naïve patients and patients on background PAH-targeted therapy who fulfilled criteria defining a positive response to therapy.</AbstractText>
<CopyrightInformation>Copyright © 2015 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.</CopyrightInformation>
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<Initials>N</Initials>
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<LastName>Ghofrani</LastName>
<ForeName>Hossein-Ardeschir</ForeName>
<Initials>HA</Initials>
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<Day>12</Day>
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<MedlineTA>J Heart Lung Transplant</MedlineTA>
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<MeshHeading>
<DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName>
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<DescriptorName UI="D016278" MajorTopicYN="N">Ventricular Function, Right</DescriptorName>
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<QualifierName UI="Q000502" MajorTopicYN="Y">physiology</QualifierName>
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<DescriptorName UI="D017725" MajorTopicYN="N">Ventricular Pressure</DescriptorName>
<QualifierName UI="Q000187" MajorTopicYN="Y">drug effects</QualifierName>
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<MeshHeading>
<DescriptorName UI="D016138" MajorTopicYN="N">Walking</DescriptorName>
<QualifierName UI="Q000502" MajorTopicYN="Y">physiology</QualifierName>
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</MeshHeadingList>
<KeywordList Owner="NOTNLM">
<Keyword MajorTopicYN="N">pulmonary arterial hypertension</Keyword>
<Keyword MajorTopicYN="N">responder threshold criteria</Keyword>
<Keyword MajorTopicYN="N">riociguat</Keyword>
<Keyword MajorTopicYN="N">soluble guanylate cyclase stimulator</Keyword>
<Keyword MajorTopicYN="N">treatment response</Keyword>
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<Year>2014</Year>
<Month>10</Month>
<Day>24</Day>
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<PubMedPubDate PubStatus="revised">
<Year>2014</Year>
<Month>12</Month>
<Day>03</Day>
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<PubMedPubDate PubStatus="accepted">
<Year>2014</Year>
<Month>12</Month>
<Day>06</Day>
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<Year>2015</Year>
<Month>2</Month>
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<Month>2</Month>
<Day>24</Day>
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<Minute>0</Minute>
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<PubMedPubDate PubStatus="medline">
<Year>2015</Year>
<Month>12</Month>
<Day>17</Day>
<Hour>6</Hour>
<Minute>0</Minute>
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<PublicationStatus>ppublish</PublicationStatus>
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<ArticleId IdType="pubmed">25703961</ArticleId>
<ArticleId IdType="pii">S1053-2498(14)01496-X</ArticleId>
<ArticleId IdType="doi">10.1016/j.healun.2014.12.001</ArticleId>
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