Riociguat for the treatment of pulmonary arterial hypertension: a long-term extension study (PATENT-2).
Identifieur interne : 002865 ( Main/Curation ); précédent : 002864; suivant : 002866Riociguat 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 :
- The European respiratory journal [ 1399-3003 ] ; 2015.
Descripteurs français
- KwdFr :
- Adulte, Adulte d'âge moyen, Antagonistes des récepteurs de l'endothéline (usage thérapeutique), Antihypertenseurs (usage thérapeutique), Estimation de Kaplan-Meier, Facteurs temps, Femelle, Guanylate cyclase (métabolisme), Humains, Hypertension pulmonaire (traitement médicamenteux), Mâle, Méthode en double aveugle, Prostaglandines (), Pyrazoles (usage thérapeutique), Pyrimidines (usage thérapeutique), Qualité de vie, Résultat thérapeutique, Sujet âgé, Sécurité des patients, Épreuve d'effort, Études de suivi.
- MESH :
- métabolisme : Guanylate cyclase.
- traitement médicamenteux : Hypertension pulmonaire.
- usage thérapeutique : Antagonistes des récepteurs de l'endothéline, Antihypertenseurs, Pyrazoles, Pyrimidines.
- Adulte, Adulte d'âge moyen, Estimation de Kaplan-Meier, Facteurs temps, Femelle, Humains, Mâle, Méthode en double aveugle, Prostaglandines, Qualité de vie, Résultat thérapeutique, Sujet âgé, Sécurité des patients, Épreuve d'effort, Études de suivi.
English descriptors
- KwdEn :
- Adult, Aged, Antihypertensive Agents (therapeutic use), Double-Blind Method, Endothelin Receptor Antagonists (therapeutic use), Exercise Test, Female, Follow-Up Studies, Guanylate Cyclase (metabolism), Humans, Hypertension, Pulmonary (drug therapy), Kaplan-Meier Estimate, Male, Middle Aged, Patient Safety, Prostaglandins (chemistry), Pyrazoles (therapeutic use), Pyrimidines (therapeutic use), Quality of Life, Time Factors, Treatment Outcome.
- MESH :
- chemical , chemistry : Prostaglandins.
- chemical , metabolism : Guanylate Cyclase.
- chemical , therapeutic use : Antihypertensive Agents, Endothelin Receptor Antagonists, Pyrazoles, Pyrimidines.
- drug therapy : Hypertension, Pulmonary.
- Adult, Aged, Double-Blind Method, Exercise Test, Female, Follow-Up Studies, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Patient Safety, Quality of Life, Time Factors, Treatment Outcome.
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
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Friedrich Grimminger<affiliation><nlm:affiliation>University of Giessen and Marburg Lung Center (UGMLC), Giessen, Germany Member of the German Center of Lung Research (DZL).</nlm:affiliation>
<wicri:noCountry code="subField">Germany Member of the German Center of Lung Research (DZL)</wicri:noCountry>
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Le document en format XML
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<term>Endothelin Receptor Antagonists</term>
<term>Pyrazoles</term>
<term>Pyrimidines</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Hypertension, Pulmonary</term>
</keywords>
<keywords scheme="MESH" qualifier="métabolisme" xml:lang="fr"><term>Guanylate cyclase</term>
</keywords>
<keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Hypertension pulmonaire</term>
</keywords>
<keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Antagonistes des récepteurs de l'endothéline</term>
<term>Antihypertenseurs</term>
<term>Pyrazoles</term>
<term>Pyrimidines</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Adult</term>
<term>Aged</term>
<term>Double-Blind Method</term>
<term>Exercise Test</term>
<term>Female</term>
<term>Follow-Up Studies</term>
<term>Humans</term>
<term>Kaplan-Meier Estimate</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Patient Safety</term>
<term>Quality of Life</term>
<term>Time Factors</term>
<term>Treatment Outcome</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Estimation de Kaplan-Meier</term>
<term>Facteurs temps</term>
<term>Femelle</term>
<term>Humains</term>
<term>Mâle</term>
<term>Méthode en double aveugle</term>
<term>Prostaglandines</term>
<term>Qualité de vie</term>
<term>Résultat thérapeutique</term>
<term>Sujet âgé</term>
<term>Sécurité des patients</term>
<term>Épreuve d'effort</term>
<term>Études de suivi</term>
</keywords>
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<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>
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