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

Lewis J. Rubin, Nazzareno Galiè, Friedrich Grimminger, Ekkehard Grünig, Marc Humbert, Zhi-Cheng Jing, Anne Keogh, David Langleben, Arno Fritsch, Flavia Menezes, Neil Davie, Hossein-Ardeschir Ghofrani
European Respiratory Journal 2015 45: 1303-1313; DOI: 10.1183/09031936.00090614
Lewis J. Rubin
1Dept of Medicine, University of California, San Diego, La Jolla, California, USA
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Nazzareno Galiè
2Dept of Experimental, Diagnostic and Specialty Medicine–DIMES, Bologna University Hospital, Bologna, Italy
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Friedrich Grimminger
3University of Giessen and Marburg Lung Center (UGMLC), Giessen, Germany
4Member of the German Center of Lung Research (DZL)
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Ekkehard Grünig
5Centre for Pulmonary Hypertension, Thoraxclinic, University Hospital Heidelberg, Heidelberg, Germany
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Marc Humbert
6Université Paris-Sud, Le Kremlin-Bicêtre, France
7AP-HP Service de Pneumologie, DHU Thorax Innovation, Hôpital Bicêtre, Le Kremlin-Bicêtre, France
8INSERM U999, LabEx LERMIT, Centre Chirurgical Marie Lannelongue, Le Plessis, Robinson, France
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Zhi-Cheng Jing
9State Key Laboratory of Cardiovascular Disease, Fu Wai Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China
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Anne Keogh
10St Vincent's Hospital, Sydney, Australia
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David Langleben
11Center for Pulmonary Vascular Disease and Lady Davis Institute, Jewish General Hospital, McGill University, Montreal, Canada
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Arno Fritsch
12Global Clinical Development, Bayer HealthCare Pharmaceuticals, Wuppertal, Germany
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Flavia Menezes
13Bayer HealthCare Pharmaceuticals, São Paulo, Brazil
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Neil Davie
12Global Clinical Development, Bayer HealthCare Pharmaceuticals, Wuppertal, Germany
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Hossein-Ardeschir Ghofrani
3University of Giessen and Marburg Lung Center (UGMLC), Giessen, Germany
4Member of the German Center of Lung Research (DZL)
14Dept of Medicine, Imperial College London, London, UK
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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.

Abstract

Riociguat was well tolerated in patients with PAH, with sustained benefits in 6MWD and WHO FC for up to 1 year http://ow.ly/EskBj

Footnotes

  • For editorial comments see Eur Respir J 2015 45: 1211–1213 [DOI: 10.1183/09031936.00032715]

  • This article has supplementary material available from erj.ersjournals.com

  • Clinical trial: This study is registered at www.clinicaltrial.gov with identifier number NCT00863681.

  • Support statement: This study was supported by Bayer HealthCare Pharmaceuticals (Berlin, Germany). Editorial assistance was provided by Adelphi Communications Ltd (Bollington, UK) sponsored by Bayer HealthCare Pharmaceuticals.

  • Conflict of interest: Disclosures can be found alongside the online version of this article at erj.ersjournals.com

  • Received May 16, 2014.
  • Accepted November 11, 2014.
  • Copyright ©ERS 2015
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Riociguat for the treatment of pulmonary arterial hypertension: a long-term extension study (PATENT-2)
Lewis J. Rubin, Nazzareno Galiè, Friedrich Grimminger, Ekkehard Grünig, Marc Humbert, Zhi-Cheng Jing, Anne Keogh, David Langleben, Arno Fritsch, Flavia Menezes, Neil Davie, Hossein-Ardeschir Ghofrani
European Respiratory Journal May 2015, 45 (5) 1303-1313; DOI: 10.1183/09031936.00090614

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Riociguat for the treatment of pulmonary arterial hypertension: a long-term extension study (PATENT-2)
Lewis J. Rubin, Nazzareno Galiè, Friedrich Grimminger, Ekkehard Grünig, Marc Humbert, Zhi-Cheng Jing, Anne Keogh, David Langleben, Arno Fritsch, Flavia Menezes, Neil Davie, Hossein-Ardeschir Ghofrani
European Respiratory Journal May 2015, 45 (5) 1303-1313; DOI: 10.1183/09031936.00090614
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