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Macitentan Improves Health-Related Quality of Life for Patients With Pulmonary Arterial Hypertension: Results From the Randomized Controlled SERAPHIN Trial.

Identifieur interne : 003C13 ( Ncbi/Merge ); précédent : 003C12; suivant : 003C14

Macitentan Improves Health-Related Quality of Life for Patients With Pulmonary Arterial Hypertension: Results From the Randomized Controlled SERAPHIN Trial.

Auteurs : Sanjay Mehta [Canada] ; Bhagavatula Kutumba Srinivasa Sastry [Inde] ; Rogério Souza [Brésil] ; Adam Torbicki [Pologne] ; Hossein-Ardeschir Ghofrani [Royaume-Uni] ; Richard N. Channick [États-Unis] ; Marion Delcroix [Belgique] ; Tomás Pulido [Mexique] ; Gérald Simonneau [France] ; John Wlodarczyk [Australie] ; Lewis J. Rubin [États-Unis] ; Pavel Jansa [République tchèque] ; Elke Hunsche [Suisse] ; Nazzareno Galiè [Italie] ; Loïc Perchenet [Suisse] ; Olivier Sitbon [France]

Source :

RBID : pubmed:27671974

Descripteurs français

English descriptors

Abstract

Pulmonary arterial hypertension (PAH) leads to reduced health-related quality of life (HRQoL). The objectives of this analysis were to evaluate the effect of macitentan on HRQoL in patients with PAH in the Study with an Endothelin Receptor Antagonist in Pulmonary Arterial Hypertension to Improve Clinical Outcome (SERAPHIN) study. The association between baseline HRQoL and long-term outcomes was also investigated.

DOI: 10.1016/j.chest.2016.08.1473
PubMed: 27671974

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pubmed:27671974

Le document en format XML

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<nlm:affiliation>University of California, San Diego Medical School, San Diego, CA.</nlm:affiliation>
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<name sortKey="Jansa, Pavel" sort="Jansa, Pavel" uniqKey="Jansa P" first="Pavel" last="Jansa">Pavel Jansa</name>
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<nlm:affiliation>Actelion Pharmaceuticals Ltd, Allschwil, Switzerland.</nlm:affiliation>
<country xml:lang="fr">Suisse</country>
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<country xml:lang="fr">Italie</country>
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<nlm:affiliation>Actelion Pharmaceuticals Ltd, Allschwil, Switzerland.</nlm:affiliation>
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<nlm:affiliation>Assistance Publique-Hôpitaux de Paris, Service de Pneumologie, Hôpital Bicêtre, Le Kremlin-Bicêtre, France; Université Paris-Sud, Laboratoire d'Excellence en Recherche sur le Médicament et Innovation Thérapeutique, Le Kremlin-Bicêtre, France, and INSERM U-999, Centre chirurgical Marie Lannelongue, Le Plessis Robinson, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Assistance Publique-Hôpitaux de Paris, Service de Pneumologie, Hôpital Bicêtre, Le Kremlin-Bicêtre, France; Université Paris-Sud, Laboratoire d'Excellence en Recherche sur le Médicament et Innovation Thérapeutique, Le Kremlin-Bicêtre, France, and INSERM U-999, Centre chirurgical Marie Lannelongue, Le Plessis Robinson</wicri:regionArea>
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<term>Endothelin B Receptor Antagonists (administration & dosage)</term>
<term>Endothelin B Receptor Antagonists (adverse effects)</term>
<term>Female</term>
<term>Humans</term>
<term>Hypertension, Pulmonary (diagnosis)</term>
<term>Hypertension, Pulmonary (drug therapy)</term>
<term>Hypertension, Pulmonary (physiopathology)</term>
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<term>Pyrimidines (administration & dosage)</term>
<term>Pyrimidines (adverse effects)</term>
<term>Quality of Life</term>
<term>Sulfonamides (administration & dosage)</term>
<term>Sulfonamides (adverse effects)</term>
<term>Treatment Outcome</term>
</keywords>
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<term>Acuité des besoins du patient</term>
<term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Antagonistes du récepteur de type B de l'endothéline (administration et posologie)</term>
<term>Antagonistes du récepteur de type B de l'endothéline (effets indésirables)</term>
<term>Femelle</term>
<term>Humains</term>
<term>Hypertension pulmonaire (diagnostic)</term>
<term>Hypertension pulmonaire (physiopathologie)</term>
<term>Hypertension pulmonaire (psychologie)</term>
<term>Hypertension pulmonaire (traitement médicamenteux)</term>
<term>Mâle</term>
<term>Pyrimidines (administration et posologie)</term>
<term>Pyrimidines (effets indésirables)</term>
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<term>Relation dose-effet des médicaments</term>
<term>Résultat thérapeutique</term>
<term>Sulfonamides (administration et posologie)</term>
<term>Sulfonamides (effets indésirables)</term>
<term>Surveillance pharmacologique ()</term>
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<term>Endothelin B Receptor Antagonists</term>
<term>Pyrimidines</term>
<term>Sulfonamides</term>
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<term>Endothelin B Receptor Antagonists</term>
<term>Pyrimidines</term>
<term>Sulfonamides</term>
</keywords>
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<term>Antagonistes du récepteur de type B de l'endothéline</term>
<term>Pyrimidines</term>
<term>Sulfonamides</term>
</keywords>
<keywords scheme="MESH" qualifier="diagnosis" xml:lang="en">
<term>Hypertension, Pulmonary</term>
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<term>Hypertension pulmonaire</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en">
<term>Hypertension, Pulmonary</term>
</keywords>
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<term>Antagonistes du récepteur de type B de l'endothéline</term>
<term>Pyrimidines</term>
<term>Sulfonamides</term>
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<term>Drug Monitoring</term>
</keywords>
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<term>Hypertension pulmonaire</term>
</keywords>
<keywords scheme="MESH" qualifier="physiopathology" xml:lang="en">
<term>Hypertension, Pulmonary</term>
</keywords>
<keywords scheme="MESH" qualifier="psychologie" xml:lang="fr">
<term>Hypertension pulmonaire</term>
</keywords>
<keywords scheme="MESH" qualifier="psychology" xml:lang="en">
<term>Hypertension, Pulmonary</term>
</keywords>
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<term>Hypertension pulmonaire</term>
</keywords>
<keywords scheme="MESH" xml:lang="en">
<term>Adult</term>
<term>Dose-Response Relationship, Drug</term>
<term>Female</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Patient Acuity</term>
<term>Quality of Life</term>
<term>Treatment Outcome</term>
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<term>Acuité des besoins du patient</term>
<term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Femelle</term>
<term>Humains</term>
<term>Mâle</term>
<term>Qualité de vie</term>
<term>Relation dose-effet des médicaments</term>
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<div type="abstract" xml:lang="en">Pulmonary arterial hypertension (PAH) leads to reduced health-related quality of life (HRQoL). The objectives of this analysis were to evaluate the effect of macitentan on HRQoL in patients with PAH in the Study with an Endothelin Receptor Antagonist in Pulmonary Arterial Hypertension to Improve Clinical Outcome (SERAPHIN) study. The association between baseline HRQoL and long-term outcomes was also investigated.</div>
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<PMID Version="1">27671974</PMID>
<DateCreated>
<Year>2016</Year>
<Month>09</Month>
<Day>27</Day>
</DateCreated>
<DateCompleted>
<Year>2017</Year>
<Month>05</Month>
<Day>12</Day>
</DateCompleted>
<DateRevised>
<Year>2017</Year>
<Month>05</Month>
<Day>12</Day>
</DateRevised>
<Article PubModel="Print-Electronic">
<Journal>
<ISSN IssnType="Electronic">1931-3543</ISSN>
<JournalIssue CitedMedium="Internet">
<Volume>151</Volume>
<Issue>1</Issue>
<PubDate>
<Year>2017</Year>
<Month>Jan</Month>
</PubDate>
</JournalIssue>
<Title>Chest</Title>
<ISOAbbreviation>Chest</ISOAbbreviation>
</Journal>
<ArticleTitle>Macitentan Improves Health-Related Quality of Life for Patients With Pulmonary Arterial Hypertension: Results From the Randomized Controlled SERAPHIN Trial.</ArticleTitle>
<Pagination>
<MedlinePgn>106-118</MedlinePgn>
</Pagination>
<ELocationID EIdType="pii" ValidYN="Y">S0012-3692(16)59209-5</ELocationID>
<ELocationID EIdType="doi" ValidYN="Y">10.1016/j.chest.2016.08.1473</ELocationID>
<Abstract>
<AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Pulmonary arterial hypertension (PAH) leads to reduced health-related quality of life (HRQoL). The objectives of this analysis were to evaluate the effect of macitentan on HRQoL in patients with PAH in the Study with an Endothelin Receptor Antagonist in Pulmonary Arterial Hypertension to Improve Clinical Outcome (SERAPHIN) study. The association between baseline HRQoL and long-term outcomes was also investigated.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">Patients were randomized to placebo, macitentan 3 mg, or macitentan 10 mg once daily. Patients aged 14 years or older completed the 36-Item Short Form Survey (SF-36) at baseline, at month 6 and month 12, and at the end of treatment (EOT). The absolute change from baseline to month 6 in SF-36 scores was calculated. The time to a clinically meaningful deterioration in the SF-36 physical component summary and mental component summary (PCS and MCS) scores and associations between baseline PCS/MCS scores and time to morbidity/mortality events were also assessed.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">At month 6, macitentan 10 mg significantly improved seven of eight SF-36 domains and the PCS and MCS scores vs placebo. Macitentan 10 mg significantly reduced the risk of a three-point or greater deterioration in PCS (hazard ratio [HR], 0.60; 95% CI, 0.47-0.76; P < .0001) and MCS scores (HR, 0.76; 95% CI, 0.61-0.95; P = .0173) until EOT vs placebo. Patients with a baseline PCS score greater than the median baseline value had a significantly reduced risk of morbidity/mortality compared with patients with a PCS score less than the median; a similar result was observed for the MCS score.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Macitentan significantly improved HRQoL in patients with PAH compared with placebo and significantly reduced the risk of a clinically meaningful HRQoL deterioration. An association between better baseline HRQoL and improved long-term outcomes was shown.</AbstractText>
<AbstractText Label="TRIAL REGISTRY" NlmCategory="BACKGROUND">ClinicalTrials.gov; No.: NCT00660179; URL: clinicaltrials.gov.</AbstractText>
<CopyrightInformation>Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.</CopyrightInformation>
</Abstract>
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<Author ValidYN="Y">
<LastName>Mehta</LastName>
<ForeName>Sanjay</ForeName>
<Initials>S</Initials>
<AffiliationInfo>
<Affiliation>London Health Sciences Centre, Victoria Hospital, Western University, London, ON, Canada. Electronic address: sanjay.mehta@lhsc.on.ca.</Affiliation>
</AffiliationInfo>
</Author>
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</AffiliationInfo>
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<Affiliation>Heart Institute, University of São Paulo Medical School, São Paulo, Brazil.</Affiliation>
</AffiliationInfo>
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<ForeName>Adam</ForeName>
<Initials>A</Initials>
<AffiliationInfo>
<Affiliation>Centre of Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Ghofrani</LastName>
<ForeName>Hossein-Ardeschir</ForeName>
<Initials>HA</Initials>
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<Affiliation>University of Giessen and Marburg Lung Center, Giessen, Germany, Member of the German Center of Lung Research (DZL), Giessen, Germany, and Department of Medicine, Imperial College London, London, England.</Affiliation>
</AffiliationInfo>
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</AffiliationInfo>
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</AffiliationInfo>
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<Initials>T</Initials>
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<Affiliation>Ignacio Chávez National Heart Institute, Mexico City, Mexico.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Simonneau</LastName>
<ForeName>Gérald</ForeName>
<Initials>G</Initials>
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<Affiliation>Assistance Publique-Hôpitaux de Paris, Service de Pneumologie, Hôpital Bicêtre, Le Kremlin-Bicêtre, France; Université Paris-Sud, Laboratoire d'Excellence en Recherche sur le Médicament et Innovation Thérapeutique, Le Kremlin-Bicêtre, France, and INSERM U-999, Centre chirurgical Marie Lannelongue, Le Plessis Robinson, France.</Affiliation>
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</AffiliationInfo>
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</AffiliationInfo>
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<Initials>E</Initials>
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</AffiliationInfo>
</Author>
<Author ValidYN="Y">
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<ForeName>Nazzareno</ForeName>
<Initials>N</Initials>
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</AffiliationInfo>
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<ForeName>Loïc</ForeName>
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</AffiliationInfo>
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