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Eur Respir J. 2015 May;45(5):1293-302. doi: 10.1183/09031936.00087114. Epub 2014 Nov 13.

Riociguat for the treatment of chronic thromboembolic pulmonary hypertension: a long-term extension study (CHEST-2).

Author information

1
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, Le Kremlin-Bicêtre, France gerald.simonneau@abc.ap-hop-paris.fr.
2
Division of Cardiothoracic Surgery, Foundation "I.R.C.C.S. Policlinico San Matteo", University of Pavia School of Medicine, Pavia, Italy.
3
University of Giessen and Marburg Lung Center (UGMLC), Giessen, Germany, and Member of the German Center of Lung Research (DZL) Dept of Medicine, Imperial College London, London, UK.
4
University of Giessen and Marburg Lung Center (UGMLC), Giessen, Germany, and Member of the German Center of Lung Research (DZL).
5
Clinic for Respiratory Medicine, Hannover Medical School, Hannover, Germany, and Member of the German Center of Lung Research (DZL).
6
Clinical Dept of Cardiology and Angiology, First Faculty of Medicine and General Teaching Hospital, Prague, Czech Republic.
7
Division of Pulmonary and Critical Care Medicine, School of Medicine, University of California San Diego, San Diego, CA, USA.
8
Beijing Institute of Respiratory Medicine, Beijing Chao Yang Hospital, Dept of Respiratory Medicine, Capital Medical University, Beijing Key Laboratory of Respiratory and Pulmonary Circulation Disorders, Beijing, China.
9
National Institute for Health Research/Wellcome Trust Imperial Clinical Research Facility, Imperial Centre for Translational and Experimental Medicine, Imperial College London, London, UK.
10
Global Clinical Development, Bayer HealthCare Pharmaceuticals, Wuppertal, Germany.
11
Global Clinical Development, Bayer HealthCare Pharmaceuticals, Barcelona, Spain.
12
Kerckhoff Heart and Lung Center, Bad Nauheim, Germany.

Abstract

Riociguat is a soluble guanylate cyclase stimulator approved for the treatment of inoperable and persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH). In the 16-week CHEST-1 study, riociguat showed a favourable benefit-risk profile and improved several clinically relevant end-points in patients with CTEPH. The CHEST-2 open-label extension evaluated the long-term safety and efficacy of riociguat. Eligible patients from CHEST-1 received riociguat individually adjusted up to a maximum dose of 2.5 mg three times daily. The primary objective was the safety and tolerability of riociguat; exploratory efficacy end-points included 6-min walking distance (6MWD) and World Health Organization (WHO) functional class (FC). Overall, 237 patients entered CHEST-2 and 211 (89%) were ongoing at this interim analysis (March 2013). The safety profile of riociguat in CHEST-2 was similar to CHEST-1, with no new safety signals. Improvements in 6MWD and WHO FC observed in CHEST-1 persisted for up to 1 year in CHEST-2. In the observed population at 1 year, mean±sd 6MWD had changed by +51±62 m (n=172) versus CHEST-1 baseline (n=237), and WHO FC had improved/stabilised/worsened in 47/50/3% of patients (n=176) versus CHEST-1 baseline (n=236). Long-term riociguat had a favourable benefit-risk profile and apparently showed sustained benefits in exercise and functional capacity for up to 1 year.

PMID:
25395036
DOI:
10.1183/09031936.00087114
[Indexed for MEDLINE]
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