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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 : 001375 ( PubMed/Corpus ); précédent : 001374; suivant : 001376

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

Auteurs : Sanjay Mehta ; Bhagavatula Kutumba Srinivasa Sastry ; Rogério Souza ; Adam Torbicki ; Hossein-Ardeschir Ghofrani ; Richard N. Channick ; Marion Delcroix ; Tomás Pulido ; Gérald Simonneau ; John Wlodarczyk ; Lewis J. Rubin ; Pavel Jansa ; Elke Hunsche ; Nazzareno Galiè ; Loïc Perchenet ; Olivier Sitbon

Source :

RBID : pubmed:27671974

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

Links to Exploration step

pubmed:27671974

Le document en format XML

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<term>Adult</term>
<term>Dose-Response Relationship, Drug</term>
<term>Drug Monitoring (methods)</term>
<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>
<term>Hypertension, Pulmonary (psychology)</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Patient Acuity</term>
<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>
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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>Hypertension, Pulmonary</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en">
<term>Hypertension, Pulmonary</term>
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<keywords scheme="MESH" qualifier="methods" xml:lang="en">
<term>Drug Monitoring</term>
</keywords>
<keywords scheme="MESH" qualifier="physiopathology" xml:lang="en">
<term>Hypertension, Pulmonary</term>
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<term>Hypertension, Pulmonary</term>
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<term>Adult</term>
<term>Dose-Response Relationship, Drug</term>
<term>Female</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
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<front>
<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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<DateCreated>
<Year>2016</Year>
<Month>09</Month>
<Day>27</Day>
</DateCreated>
<DateCompleted>
<Year>2017</Year>
<Month>05</Month>
<Day>12</Day>
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<Year>2017</Year>
<Month>05</Month>
<Day>12</Day>
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<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>
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<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>
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<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>
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<Affiliation>Ignacio Chávez National Heart Institute, Mexico City, Mexico.</Affiliation>
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<ForeName>Lewis J</ForeName>
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<Affiliation>University of California, San Diego Medical School, San Diego, CA.</Affiliation>
</AffiliationInfo>
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<Affiliation>Charles University, Prague, Czech Republic.</Affiliation>
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<Affiliation>Actelion Pharmaceuticals Ltd, Allschwil, Switzerland.</Affiliation>
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<Affiliation>Bologna University Hospital, Bologna, Italy.</Affiliation>
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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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<Keyword MajorTopicYN="Y">pharmacotherapy</Keyword>
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<Day>03</Day>
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<Year>2016</Year>
<Month>07</Month>
<Day>29</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="accepted">
<Year>2016</Year>
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<Day>24</Day>
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<Month>9</Month>
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<ArticleId IdType="pii">S0012-3692(16)59209-5</ArticleId>
<ArticleId IdType="doi">10.1016/j.chest.2016.08.1473</ArticleId>
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