Riociguat for the Treatment of Pulmonary Arterial Hypertension
Identifieur interne : 004C90 ( Main/Exploration ); précédent : 004C89; suivant : 004C91Riociguat for the Treatment of Pulmonary Arterial Hypertension
Auteurs : Hossein-Ardeschir Ghofrani [Allemagne, Royaume-Uni] ; Nazzareno Galie [Italie] ; Friedrich Grimminger [Allemagne] ; Ekkehard Grünig [Allemagne] ; Marc Humbert [France] ; ZHI-CHENG JING [République populaire de Chine] ; Anne M. Keogh [Australie] ; David Langleben [Canada] ; MICHAEL OCHAN KILAMA [Italie] ; Arno Fritsch [Allemagne] ; Dieter Neuser [Allemagne] ; Lewis J. Rubin [États-Unis]Source :
- The New England journal of medicine [ 0028-4793 ] ; 2013.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Médecine.
English descriptors
- KwdEn :
Abstract
BACKGROUND Riociguat, a soluble guanylate cyclase stimulator, has been shown in a phase 2 trial to be beneficial in the treatment of pulmonary arterial hypertension. METHODS In this phase 3, double-blind study, we randomly assigned 443 patients with symptomatic pulmonary arterial hypertension to receive placebo, riociguat in individually adjusted doses of up to 2.5 mg three times daily (2.5 mg-maximum group), or riociguat in individually adjusted doses that were capped at 1.5 mg three times daily (1.5 mg-maximum group). The 1.5 mg-maximum group was included for exploratory purposes, and the data from that group were analyzed descriptively. Patients who were receiving no other treatment for pulmonary arterial hypertension and patients who were receiving endothelin-receptor antagonists or (nonintravenous) prostanoids were eligible. The primary end point was the change from baseline to the end of week 12 in the distance walked in 6 minutes. Secondary end points included the change in pulmonary vascular resistance, N-terminal pro-brain natriuretic peptide (NT-proBNP) levels, World Health Organization (WHO) functional class, time to clinical worsening, score on the Borg dyspnea scale, quality-of-life variables, and safety. RESULTS By week 12, the 6-minute walk distance had increased by a mean of 30 m in the 2.5 mg-maximum group and had decreased by a mean of 6 m in the placebo group (least-squares mean difference, 36 m; 95% confidence interval, 20 to 52; P<0.001). Prespecified subgroup analyses showed that riociguat improved the 6-minute walk distance both in patients who were receiving no other treatment for the disease and in those who were receiving endothelin-receptor antagonists or prostanoids. There were significant improvements in pulmonary vascular resistance (P<0.001), NT-proBNP levels (P<0.001), WHO functional class (P=0.003), time to clinical worsening (P=0.005), and Borg dyspnea score (P=0.002). The most common serious adverse event in the placebo group and the 2.5 mg-maximum group was syncope (4% and 1%, respectively). CONCLUSIONS Riociguat significantly improved exercise capacity and secondary efficacy end points in patients with pulmonary arterial hypertension.
Affiliations:
- Allemagne, Australie, Canada, France, Italie, Royaume-Uni, République populaire de Chine, États-Unis
- Angleterre, Bade-Wurtemberg, District de Karlsruhe, Grand Londres, Lombardie, Nouvelle-Galles du Sud, Québec, Île-de-France
- Heidelberg, Londres, Milan, Montréal, Orsay, Pékin, Sydney
- Université McGill, Université Paris-Sud
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Keogh</name><affiliation wicri:level="3"><inist:fA14 i1="09"><s1>St. Vincent's Hospital</s1><s2>Sydney</s2><s3>AUS</s3><sZ>7 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation></author><author><name sortKey="Langleben, David" sort="Langleben, David" uniqKey="Langleben D" first="David" last="Langleben">David Langleben</name><affiliation wicri:level="4"><inist:fA14 i1="10"><s1>Center for Pulmonary Vascular Disease and Lady Davis Institute, Jewish General Hospital, McGill University</s1><s2>Montreal</s2><s3>CAN</s3><sZ>8 aut.</sZ></inist:fA14><country>Canada</country><placeName><settlement type="city">Montréal</settlement><region type="state">Québec</region><settlement type="city">Montréal</settlement></placeName><orgName type="university">Université McGill</orgName></affiliation></author><author><name sortKey="Michael Ochan Kilama" sort="Michael Ochan Kilama" uniqKey="Michael Ochan Kilama" last="Michael Ochan Kilama">MICHAEL OCHAN KILAMA</name><affiliation wicri:level="3"><inist:fA14 i1="06"><s1>Global Clinical Development, Bayer Healthcare</s1><s2>Milan</s2><s3>ITA</s3><sZ>9 aut.</sZ></inist:fA14><country>Italie</country><placeName><settlement type="city">Milan</settlement><region nuts="2">Lombardie</region></placeName></affiliation></author><author><name sortKey="Fritsch, Arno" sort="Fritsch, Arno" uniqKey="Fritsch A" first="Arno" last="Fritsch">Arno Fritsch</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Global Clinical Development, Bayer HealthCare</s1><s2>Wuppertal</s2><s3>DEU</s3><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>Wuppertal</wicri:noRegion><wicri:noRegion>Bayer HealthCare</wicri:noRegion><wicri:noRegion>Wuppertal</wicri:noRegion></affiliation></author><author><name sortKey="Neuser, Dieter" sort="Neuser, Dieter" uniqKey="Neuser D" first="Dieter" last="Neuser">Dieter Neuser</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Global Clinical Development, Bayer HealthCare</s1><s2>Wuppertal</s2><s3>DEU</s3><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>Wuppertal</wicri:noRegion><wicri:noRegion>Bayer HealthCare</wicri:noRegion><wicri:noRegion>Wuppertal</wicri:noRegion></affiliation></author><author><name sortKey="Rubin, Lewis J" sort="Rubin, Lewis J" uniqKey="Rubin L" first="Lewis J." last="Rubin">Lewis J. Rubin</name><affiliation wicri:level="1"><inist:fA14 i1="11"><s1>University of California</s1><s2>San Diego, La Jolla</s2><s3>USA</s3><sZ>12 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>University of California</wicri:noRegion></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">13-0233284</idno><date when="2013">2013</date><idno type="stanalyst">PASCAL 13-0233284 INIST</idno><idno type="RBID">Pascal:13-0233284</idno><idno type="wicri:Area/PascalFrancis/Corpus">000956</idno><idno type="wicri:Area/PascalFrancis/Curation">005520</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">000661</idno><idno type="wicri:explorRef" wicri:stream="PascalFrancis" wicri:step="Checkpoint">000661</idno><idno type="wicri:doubleKey">0028-4793:2013:Ghofrani H:riociguat:for:the</idno><idno type="wicri:Area/Main/Merge">004E35</idno><idno type="wicri:Area/Main/Curation">004C90</idno><idno type="wicri:Area/Main/Exploration">004C90</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Riociguat for the Treatment of Pulmonary Arterial Hypertension</title><author><name sortKey="Ghofrani, Hossein Ardeschir" sort="Ghofrani, Hossein Ardeschir" uniqKey="Ghofrani H" first="Hossein-Ardeschir" last="Ghofrani">Hossein-Ardeschir Ghofrani</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>University of Giessen and Marburg Lung Center, Giessen, German Center for Lung Research</s1><s3>DEU</s3><sZ>1 aut.</sZ><sZ>3 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>German Center for Lung Research</wicri:noRegion><wicri:noRegion>University of Giessen and Marburg Lung Center, Giessen, German Center for Lung Research</wicri:noRegion></affiliation><affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Department of Medicine, Imperial College London</s1><s2>London</s2><s3>GBR</s3><sZ>1 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Galie, Nazzareno" sort="Galie, Nazzareno" uniqKey="Galie N" first="Nazzareno" last="Galie">Nazzareno Galie</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Department of Experimental, Diagnostic, and Specialty Medicine, Bologna University Hospital</s1><s2>Bologna</s2><s3>ITA</s3><sZ>2 aut.</sZ></inist:fA14><country>Italie</country><wicri:noRegion>Bologna</wicri:noRegion></affiliation></author><author><name sortKey="Grimminger, Friedrich" sort="Grimminger, Friedrich" uniqKey="Grimminger F" first="Friedrich" last="Grimminger">Friedrich Grimminger</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>University of Giessen and Marburg Lung Center, Giessen, German Center for Lung Research</s1><s3>DEU</s3><sZ>1 aut.</sZ><sZ>3 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>German Center for Lung Research</wicri:noRegion><wicri:noRegion>University of Giessen and Marburg Lung Center, Giessen, German Center for Lung Research</wicri:noRegion></affiliation></author><author><name sortKey="Grunig, Ekkehard" sort="Grunig, Ekkehard" uniqKey="Grunig E" first="Ekkehard" last="Grünig">Ekkehard Grünig</name><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Center for Pulmonary Hypertension, Thoraxclinic, University Hospital Heidelberg</s1><s2>Heidelberg</s2><s3>DEU</s3><sZ>4 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author><author><name sortKey="Humbert, Marc" sort="Humbert, Marc" uniqKey="Humbert M" first="Marc" last="Humbert">Marc Humbert</name><affiliation wicri:level="4"><inist:fA14 i1="07"><s1>Assistance Publique-Hôpitaux de Paris, Service de Pneumologie, Hôpital Bicêtre, Université Paris-Sud, Laboratoire d'Excellence en Recherche sur le Médicament et Innovation Thérapeutique, and INSERM Unité 999</s1><s2>Le Kremlin-Bicêtre</s2><s3>FRA</s3><sZ>5 aut.</sZ></inist:fA14><country>France</country><wicri:noRegion>Le Kremlin-Bicêtre</wicri:noRegion><wicri:noRegion>and INSERM Unité 999</wicri:noRegion><wicri:noRegion>Le Kremlin-Bicêtre</wicri:noRegion><orgName type="university">Université Paris-Sud</orgName><placeName><settlement type="city">Orsay</settlement><region type="region" nuts="2">Île-de-France</region></placeName></affiliation></author><author><name sortKey="Zhi Cheng Jing" sort="Zhi Cheng Jing" uniqKey="Zhi Cheng Jing" last="Zhi-Cheng Jing">ZHI-CHENG JING</name><affiliation wicri:level="3"><inist:fA14 i1="08"><s1>State Key Laboratory of Cardiovascular Disease, Fu Wai Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences</s1><s2>Beijing</s2><s3>CHN</s3><sZ>6 aut.</sZ></inist:fA14><country>République populaire de Chine</country><placeName><settlement type="city">Pékin</settlement></placeName></affiliation></author><author><name sortKey="Keogh, Anne M" sort="Keogh, Anne M" uniqKey="Keogh A" first="Anne M." last="Keogh">Anne M. Keogh</name><affiliation wicri:level="3"><inist:fA14 i1="09"><s1>St. Vincent's Hospital</s1><s2>Sydney</s2><s3>AUS</s3><sZ>7 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation></author><author><name sortKey="Langleben, David" sort="Langleben, David" uniqKey="Langleben D" first="David" last="Langleben">David Langleben</name><affiliation wicri:level="4"><inist:fA14 i1="10"><s1>Center for Pulmonary Vascular Disease and Lady Davis Institute, Jewish General Hospital, McGill University</s1><s2>Montreal</s2><s3>CAN</s3><sZ>8 aut.</sZ></inist:fA14><country>Canada</country><placeName><settlement type="city">Montréal</settlement><region type="state">Québec</region><settlement type="city">Montréal</settlement></placeName><orgName type="university">Université McGill</orgName></affiliation></author><author><name sortKey="Michael Ochan Kilama" sort="Michael Ochan Kilama" uniqKey="Michael Ochan Kilama" last="Michael Ochan Kilama">MICHAEL OCHAN KILAMA</name><affiliation wicri:level="3"><inist:fA14 i1="06"><s1>Global Clinical Development, Bayer Healthcare</s1><s2>Milan</s2><s3>ITA</s3><sZ>9 aut.</sZ></inist:fA14><country>Italie</country><placeName><settlement type="city">Milan</settlement><region nuts="2">Lombardie</region></placeName></affiliation></author><author><name sortKey="Fritsch, Arno" sort="Fritsch, Arno" uniqKey="Fritsch A" first="Arno" last="Fritsch">Arno Fritsch</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Global Clinical Development, Bayer HealthCare</s1><s2>Wuppertal</s2><s3>DEU</s3><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>Wuppertal</wicri:noRegion><wicri:noRegion>Bayer HealthCare</wicri:noRegion><wicri:noRegion>Wuppertal</wicri:noRegion></affiliation></author><author><name sortKey="Neuser, Dieter" sort="Neuser, Dieter" uniqKey="Neuser D" first="Dieter" last="Neuser">Dieter Neuser</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Global Clinical Development, Bayer HealthCare</s1><s2>Wuppertal</s2><s3>DEU</s3><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>Wuppertal</wicri:noRegion><wicri:noRegion>Bayer HealthCare</wicri:noRegion><wicri:noRegion>Wuppertal</wicri:noRegion></affiliation></author><author><name sortKey="Rubin, Lewis J" sort="Rubin, Lewis J" uniqKey="Rubin L" first="Lewis J." last="Rubin">Lewis J. Rubin</name><affiliation wicri:level="1"><inist:fA14 i1="11"><s1>University of California</s1><s2>San Diego, La Jolla</s2><s3>USA</s3><sZ>12 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>University of California</wicri:noRegion></affiliation></author></analytic><series><title level="j" type="main">The New England journal of medicine</title><title level="j" type="abbreviated">N. Engl. j. med.</title><idno type="ISSN">0028-4793</idno><imprint><date when="2013">2013</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">The New England journal of medicine</title><title level="j" type="abbreviated">N. Engl. j. med.</title><idno type="ISSN">0028-4793</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Artery</term><term>Medicine</term><term>Pulmonary hypertension</term><term>Treatment</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Hypertension artérielle pulmonaire</term><term>Traitement</term><term>Artère</term><term>Médecine</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Médecine</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">BACKGROUND Riociguat, a soluble guanylate cyclase stimulator, has been shown in a phase 2 trial to be beneficial in the treatment of pulmonary arterial hypertension. METHODS In this phase 3, double-blind study, we randomly assigned 443 patients with symptomatic pulmonary arterial hypertension to receive placebo, riociguat in individually adjusted doses of up to 2.5 mg three times daily (2.5 mg-maximum group), or riociguat in individually adjusted doses that were capped at 1.5 mg three times daily (1.5 mg-maximum group). The 1.5 mg-maximum group was included for exploratory purposes, and the data from that group were analyzed descriptively. Patients who were receiving no other treatment for pulmonary arterial hypertension and patients who were receiving endothelin-receptor antagonists or (nonintravenous) prostanoids were eligible. The primary end point was the change from baseline to the end of week 12 in the distance walked in 6 minutes. Secondary end points included the change in pulmonary vascular resistance, N-terminal pro-brain natriuretic peptide (NT-proBNP) levels, World Health Organization (WHO) functional class, time to clinical worsening, score on the Borg dyspnea scale, quality-of-life variables, and safety. RESULTS By week 12, the 6-minute walk distance had increased by a mean of 30 m in the 2.5 mg-maximum group and had decreased by a mean of 6 m in the placebo group (least-squares mean difference, 36 m; 95% confidence interval, 20 to 52; P<0.001). Prespecified subgroup analyses showed that riociguat improved the 6-minute walk distance both in patients who were receiving no other treatment for the disease and in those who were receiving endothelin-receptor antagonists or prostanoids. There were significant improvements in pulmonary vascular resistance (P<0.001), NT-proBNP levels (P<0.001), WHO functional class (P=0.003), time to clinical worsening (P=0.005), and Borg dyspnea score (P=0.002). The most common serious adverse event in the placebo group and the 2.5 mg-maximum group was syncope (4% and 1%, respectively). CONCLUSIONS Riociguat significantly improved exercise capacity and secondary efficacy end points in patients with pulmonary arterial hypertension.</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Australie</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>District de Karlsruhe</li><li>Grand Londres</li><li>Lombardie</li><li>Nouvelle-Galles du Sud</li><li>Québec</li><li>Île-de-France</li></region><settlement><li>Heidelberg</li><li>Londres</li><li>Milan</li><li>Montréal</li><li>Orsay</li><li>Pékin</li><li>Sydney</li></settlement><orgName><li>Université McGill</li><li>Université Paris-Sud</li></orgName></list><tree><country name="Allemagne"><noRegion><name sortKey="Ghofrani, Hossein Ardeschir" sort="Ghofrani, Hossein Ardeschir" uniqKey="Ghofrani H" first="Hossein-Ardeschir" last="Ghofrani">Hossein-Ardeschir Ghofrani</name></noRegion><name sortKey="Fritsch, Arno" sort="Fritsch, Arno" uniqKey="Fritsch A" first="Arno" last="Fritsch">Arno Fritsch</name><name sortKey="Grimminger, Friedrich" sort="Grimminger, Friedrich" uniqKey="Grimminger F" first="Friedrich" last="Grimminger">Friedrich Grimminger</name><name sortKey="Grunig, Ekkehard" sort="Grunig, Ekkehard" uniqKey="Grunig E" first="Ekkehard" last="Grünig">Ekkehard Grünig</name><name sortKey="Neuser, Dieter" sort="Neuser, Dieter" uniqKey="Neuser D" first="Dieter" last="Neuser">Dieter Neuser</name></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><country name="Italie"><noRegion><name sortKey="Galie, Nazzareno" sort="Galie, Nazzareno" uniqKey="Galie N" first="Nazzareno" last="Galie">Nazzareno Galie</name></noRegion><name sortKey="Michael Ochan Kilama" sort="Michael Ochan Kilama" uniqKey="Michael Ochan Kilama" last="Michael Ochan Kilama">MICHAEL OCHAN KILAMA</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="Zhi Cheng Jing" sort="Zhi Cheng Jing" uniqKey="Zhi Cheng Jing" last="Zhi-Cheng Jing">ZHI-CHENG JING</name></noRegion></country><country name="Australie"><region name="Nouvelle-Galles du Sud"><name sortKey="Keogh, Anne M" sort="Keogh, Anne M" uniqKey="Keogh A" first="Anne M." last="Keogh">Anne M. 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="États-Unis"><noRegion><name sortKey="Rubin, Lewis J" sort="Rubin, Lewis J" uniqKey="Rubin L" first="Lewis J." last="Rubin">Lewis J. Rubin</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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