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Riociguat for the treatment of pulmonary arterial hypertension: a long-term extension study (PATENT-2).

Identifieur interne : 002865 ( Main/Exploration ); précédent : 002864; suivant : 002866

Riociguat for the treatment of pulmonary arterial hypertension: a long-term extension study (PATENT-2).

Auteurs : Lewis J. Rubin [États-Unis] ; Nazzareno Galiè [Italie] ; Friedrich Grimminger ; Ekkehard Grünig [Allemagne] ; Marc Humbert [France] ; Zhi-Cheng Jing [République populaire de Chine] ; Anne Keogh [Australie] ; David Langleben [Canada] ; Arno Fritsch [Allemagne] ; Flavia Menezes [Brésil] ; Neil Davie [Allemagne] ; Hossein-Ardeschir Ghofrani [Royaume-Uni]

Source :

RBID : pubmed:25614164

Descripteurs français

English descriptors

Abstract

Riociguat is a soluble, guanylate cyclase stimulator, approved for pulmonary arterial hypertension. In the 12-week PATENT-1 study, riociguat was well tolerated and improved several clinically relevant end-points in patients with pulmonary arterial hypertension who were treatment naïve or had been pretreated with endothelin-receptor antagonists or prostanoids. The PATENT-2 open-label extension evaluated the long-term safety and efficacy of riociguat. Eligible patients from the PATENT-1 study received riociguat individually adjusted up to a maximum dose of 2.5 mg three times daily. The primary objective was to assess the safety and tolerability of riociguat; exploratory efficacy assessments included 6-min walking distance and World Health Organization (WHO) functional class. Overall, 396 patients entered the PATENT-2 study and 324 (82%) were ongoing at this interim analysis (March 2013). The safety profile of riociguat in PATENT-2 was similar to that observed in PATENT-1, with cases of haemoptysis and pulmonary haemorrhage also being observed in PATENT-2. Improvements in the patients', 6-min walking distance and WHO functional class observed in PATENT-1 persisted for up to 1 year in PATENT-2. In the observed population at the 1-year time point, mean±sd 6-min walking distance had changed by 51±74 m and WHO functional class had improved in 33%, stabilised in 61% and worsened in 6% of the patients versus the PATENT-1 baseline. Long-term riociguat was well tolerated in patients with pulmonary arterial hypertension, and led to sustained improvements in exercise capacity and functional capacity for up to 1 year.

DOI: 10.1183/09031936.00090614
PubMed: 25614164


Affiliations:


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Le document en format XML

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<term>Sécurité des patients</term>
<term>Épreuve d'effort</term>
<term>Études de suivi</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front>
<div type="abstract" xml:lang="en">Riociguat is a soluble, guanylate cyclase stimulator, approved for pulmonary arterial hypertension. In the 12-week PATENT-1 study, riociguat was well tolerated and improved several clinically relevant end-points in patients with pulmonary arterial hypertension who were treatment naïve or had been pretreated with endothelin-receptor antagonists or prostanoids. The PATENT-2 open-label extension evaluated the long-term safety and efficacy of riociguat. Eligible patients from the PATENT-1 study received riociguat individually adjusted up to a maximum dose of 2.5 mg three times daily. The primary objective was to assess the safety and tolerability of riociguat; exploratory efficacy assessments included 6-min walking distance and World Health Organization (WHO) functional class. Overall, 396 patients entered the PATENT-2 study and 324 (82%) were ongoing at this interim analysis (March 2013). The safety profile of riociguat in PATENT-2 was similar to that observed in PATENT-1, with cases of haemoptysis and pulmonary haemorrhage also being observed in PATENT-2. Improvements in the patients', 6-min walking distance and WHO functional class observed in PATENT-1 persisted for up to 1 year in PATENT-2. In the observed population at the 1-year time point, mean±sd 6-min walking distance had changed by 51±74 m and WHO functional class had improved in 33%, stabilised in 61% and worsened in 6% of the patients versus the PATENT-1 baseline. Long-term riociguat was well tolerated in patients with pulmonary arterial hypertension, and led to sustained improvements in exercise capacity and functional capacity for up to 1 year.</div>
</front>
</TEI>
<affiliations>
<list>
<country>
<li>Allemagne</li>
<li>Australie</li>
<li>Brésil</li>
<li>Canada</li>
<li>France</li>
<li>Italie</li>
<li>Royaume-Uni</li>
<li>République populaire de Chine</li>
<li>États-Unis</li>
</country>
<region>
<li>Angleterre</li>
<li>Bade-Wurtemberg</li>
<li>Californie</li>
<li>District de Karlsruhe</li>
<li>Grand Londres</li>
<li>Nouvelle-Galles du Sud</li>
<li>Québec</li>
<li>État de São Paulo</li>
<li>Île-de-France</li>
</region>
<settlement>
<li>Heidelberg</li>
<li>Londres</li>
<li>Montréal</li>
<li>Orsay</li>
<li>Pékin</li>
<li>Sydney</li>
<li>São Paulo</li>
</settlement>
<orgName>
<li>Université McGill</li>
<li>Université Paris-Sud</li>
</orgName>
</list>
<tree>
<noCountry>
<name sortKey="Grimminger, Friedrich" sort="Grimminger, Friedrich" uniqKey="Grimminger F" first="Friedrich" last="Grimminger">Friedrich Grimminger</name>
</noCountry>
<country name="États-Unis">
<region name="Californie">
<name sortKey="Rubin, Lewis J" sort="Rubin, Lewis J" uniqKey="Rubin L" first="Lewis J" last="Rubin">Lewis J. Rubin</name>
</region>
</country>
<country name="Italie">
<noRegion>
<name sortKey="Galie, Nazzareno" sort="Galie, Nazzareno" uniqKey="Galie N" first="Nazzareno" last="Galiè">Nazzareno Galiè</name>
</noRegion>
</country>
<country name="Allemagne">
<region name="Bade-Wurtemberg">
<name sortKey="Grunig, Ekkehard" sort="Grunig, Ekkehard" uniqKey="Grunig E" first="Ekkehard" last="Grünig">Ekkehard Grünig</name>
</region>
<name sortKey="Davie, Neil" sort="Davie, Neil" uniqKey="Davie N" first="Neil" last="Davie">Neil Davie</name>
<name sortKey="Fritsch, Arno" sort="Fritsch, Arno" uniqKey="Fritsch A" first="Arno" last="Fritsch">Arno Fritsch</name>
</country>
<country name="France">
<region name="Île-de-France">
<name sortKey="Humbert, Marc" sort="Humbert, Marc" uniqKey="Humbert M" first="Marc" last="Humbert">Marc Humbert</name>
</region>
</country>
<country name="République populaire de Chine">
<noRegion>
<name sortKey="Jing, Zhi Cheng" sort="Jing, Zhi Cheng" uniqKey="Jing Z" first="Zhi-Cheng" last="Jing">Zhi-Cheng Jing</name>
</noRegion>
</country>
<country name="Australie">
<region name="Nouvelle-Galles du Sud">
<name sortKey="Keogh, Anne" sort="Keogh, Anne" uniqKey="Keogh A" first="Anne" last="Keogh">Anne Keogh</name>
</region>
</country>
<country name="Canada">
<region name="Québec">
<name sortKey="Langleben, David" sort="Langleben, David" uniqKey="Langleben D" first="David" last="Langleben">David Langleben</name>
</region>
</country>
<country name="Brésil">
<region name="État de São Paulo">
<name sortKey="Menezes, Flavia" sort="Menezes, Flavia" uniqKey="Menezes F" first="Flavia" last="Menezes">Flavia Menezes</name>
</region>
</country>
<country name="Royaume-Uni">
<region name="Angleterre">
<name sortKey="Ghofrani, Hossein Ardeschir" sort="Ghofrani, Hossein Ardeschir" uniqKey="Ghofrani H" first="Hossein-Ardeschir" last="Ghofrani">Hossein-Ardeschir Ghofrani</name>
</region>
</country>
</tree>
</affiliations>
</record>

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