Clinical trial design and new therapies for pulmonary arterial hypertension
Identifieur interne : 000114 ( France/Analysis ); précédent : 000113; suivant : 000115Clinical trial design and new therapies for pulmonary arterial hypertension
Auteurs : Olivier Sitbon [France] ; Mardi Gomberg-Maitland [États-Unis] ; John Granton [Canada] ; Michael I. Lewis [États-Unis] ; Stephen C. Mathai [États-Unis] ; Maurizio Rainisio [Italie] ; Norman L. Stockbridge [États-Unis] ; Martin R. Wilkins [Royaume-Uni] ; Roham T. Zamanian [États-Unis] ; Lewis J. Rubin [États-Unis]Source :
- The European Respiratory Journal [ 0903-1936 ] ; 2019.
Abstract
Until 20 years ago the treatment of pulmonary arterial hypertension (PAH) was based on case reports and small series, and was largely ineffectual. As a deeper understanding of the pathogenesis and pathophysiology of PAH evolved over the subsequent two decades, coupled with epidemiological studies defining the clinical and demographic characteristics of the condition, a renewed interest in treatment development emerged through collaborations between international experts, industry and regulatory agencies. These efforts led to the performance of robust, high-quality clinical trials of novel therapies that targeted putative pathogenic pathways, leading to the approval of more than 10 novel therapies that have beneficially impacted both the quality and duration of life. However, our understanding of PAH remains incomplete and there is no cure. Accordingly, efforts are now focused on identifying novel pathogenic pathways that may be targeted, and applying more rigorous clinical trial designs to better define the efficacy of these new potential treatments and their role in the management scheme. This article, prepared by a Task Force comprised of expert clinicians, trialists and regulators, summarises the current state of the art, and provides insight into the opportunities and challenges for identifying and assessing the efficacy and safety of new treatments for this challenging condition.
Url:
DOI: 10.1183/13993003.01908-2018
PubMed: 30545975
PubMed Central: 6351342
Affiliations:
- Canada, France, Italie, Royaume-Uni, États-Unis
- Angleterre, Californie, District de Columbia, Grand Londres, Maryland, Île-de-France
- Londres, Orsay
- Université Paris-Sud
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PMC:6351342Le document en format XML
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Rubin</name><affiliation wicri:level="2"><nlm:aff id="af10">San Diego School of Medicine, University of California, La Jolla, CA, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>San Diego School of Medicine, University of California, La Jolla, CA</wicri:regionArea><placeName><region type="state">Californie</region></placeName></affiliation></author></analytic><series><title level="j">The European Respiratory Journal</title><idno type="ISSN">0903-1936</idno><idno type="eISSN">1399-3003</idno><imprint><date when="2019">2019</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>Until 20 years ago the treatment of pulmonary arterial hypertension (PAH) was based on case reports and small series, and was largely ineffectual. As a deeper understanding of the pathogenesis and pathophysiology of PAH evolved over the subsequent two decades, coupled with epidemiological studies defining the clinical and demographic characteristics of the condition, a renewed interest in treatment development emerged through collaborations between international experts, industry and regulatory agencies. These efforts led to the performance of robust, high-quality clinical trials of novel therapies that targeted putative pathogenic pathways, leading to the approval of more than 10 novel therapies that have beneficially impacted both the quality and duration of life. However, our understanding of PAH remains incomplete and there is no cure. Accordingly, efforts are now focused on identifying novel pathogenic pathways that may be targeted, and applying more rigorous clinical trial designs to better define the efficacy of these new potential treatments and their role in the management scheme. This article, prepared by a Task Force comprised of expert clinicians, trialists and regulators, summarises the current state of the art, and provides insight into the opportunities and challenges for identifying and assessing the efficacy and safety of new treatments for this challenging condition.</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Barst, Rj" uniqKey="Barst R">RJ Barst</name></author><author><name sortKey="Rubin, Lj" uniqKey="Rubin L">LJ Rubin</name></author><author><name sortKey="Long, Wa" uniqKey="Long W">WA Long</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Simonneau, G" uniqKey="Simonneau G">G Simonneau</name></author><author><name sortKey="Barst, Rj" uniqKey="Barst R">RJ Barst</name></author><author><name sortKey="Galie, N" uniqKey="Galie N">N Galiè</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Rubin, Lj" uniqKey="Rubin L">LJ 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uniqKey="Shapiro S">S Shapiro</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Galie, N" uniqKey="Galie N">N Galiè</name></author><author><name sortKey="Boonstra, A" uniqKey="Boonstra A">A Boonstra</name></author><author><name sortKey="Evert, R" uniqKey="Evert R">R Evert</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Canada</li><li>France</li><li>Italie</li><li>Royaume-Uni</li><li>États-Unis</li></country><region><li>Angleterre</li><li>Californie</li><li>District de Columbia</li><li>Grand Londres</li><li>Maryland</li><li>Île-de-France</li></region><settlement><li>Londres</li><li>Orsay</li></settlement><orgName><li>Université Paris-Sud</li></orgName></list><tree><country name="France"><region name="Île-de-France"><name sortKey="Sitbon, Olivier" sort="Sitbon, Olivier" uniqKey="Sitbon O" first="Olivier" last="Sitbon">Olivier Sitbon</name></region></country><country name="États-Unis"><region name="District de Columbia"><name sortKey="Gomberg Maitland, Mardi" sort="Gomberg Maitland, Mardi" uniqKey="Gomberg Maitland M" first="Mardi" last="Gomberg-Maitland">Mardi Gomberg-Maitland</name></region><name sortKey="Lewis, Michael I" sort="Lewis, Michael I" uniqKey="Lewis M" first="Michael I." last="Lewis">Michael I. Lewis</name><name sortKey="Mathai, Stephen C" sort="Mathai, Stephen C" uniqKey="Mathai S" first="Stephen C." last="Mathai">Stephen C. Mathai</name><name sortKey="Rubin, Lewis J" sort="Rubin, Lewis J" uniqKey="Rubin L" first="Lewis J." last="Rubin">Lewis J. Rubin</name><name sortKey="Stockbridge, Norman L" sort="Stockbridge, Norman L" uniqKey="Stockbridge N" first="Norman L." last="Stockbridge">Norman L. Stockbridge</name><name sortKey="Zamanian, Roham T" sort="Zamanian, Roham T" uniqKey="Zamanian R" first="Roham T." last="Zamanian">Roham T. Zamanian</name></country><country name="Canada"><noRegion><name sortKey="Granton, John" sort="Granton, John" uniqKey="Granton J" first="John" last="Granton">John Granton</name></noRegion></country><country name="Italie"><noRegion><name sortKey="Rainisio, Maurizio" sort="Rainisio, Maurizio" uniqKey="Rainisio M" first="Maurizio" last="Rainisio">Maurizio Rainisio</name></noRegion></country><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Wilkins, Martin R" sort="Wilkins, Martin R" uniqKey="Wilkins M" first="Martin R." last="Wilkins">Martin R. Wilkins</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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