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Effects of riociguat in patients with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) following pulmonary endarterectomy (PEA)

Eckhard Mayer, Andrzej Biederman, Andrea M. D'Armini, Ekkehard Grünig, Pavel Jansa, David P. Jenkins, Nick H. Kim, Walter Klepetko, Jaroslav Lindner, Michael M. Madani, Chen Wang, Neil Davie, Arno Fritsch, Hossein-Ardeschir Ghofrani
European Respiratory Journal 2014 44: 3421; DOI:
Eckhard Mayer
1Department of Thoracic Surgery, Kerckhoff Heart and Lung Center, Bad Nauheim, Germany
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Andrzej Biederman
2Department of Cardiac Surgery, Alendort Hospital, Warsaw, Poland
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Andrea M. D'Armini
3Division of Cardiothoracic Surgery, Foundation "I.R.C.C.S. Policlinico San Matteo", University of Pavia School of Medicine, Pavia, Italy
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Ekkehard Grünig
4Centre for Pulmonary Hypertension, Thoraxclinic, University Hospital Heidelberg, Heidelberg, Germany
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Pavel Jansa
5Clinical Department of Cardiology and Angiology, First Faculty of Medicine and General Teaching Hospital, Prague, Czech Republic
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David P. Jenkins
6National Pulmonary Endarterectomy Service, Papworth Hospital, Cambridge, United Kingdom
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Nick H. Kim
7Division of Pulmonary and Critical Care Medicine, UCSD School of Medicine, San Diego, CA,
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Walter Klepetko
8Department of Cardiothoracic Surgery, Vienna General Hospital, Medical University of Vienna, Vienna, Austria
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Jaroslav Lindner
92nd Surgical Department – Clinical Department of Cardiovascular Surgery, Charles University Prague, First Faculty of Medicine and General Teaching Hospital, Prague, Czech Republic
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Michael M. Madani
10Division of Cardiovascular and Thoracic Surgery, University of California San Diego Medical Center, San Diego, CA,
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Chen Wang
11Beijing Institute of Respiratory Medicine, Beijing Chao Yang Hospital, Department of Respiratory Medicine, Capital Medical University, Beijing Key Laboratory of Respiratory and Pulmonary Circulation Disorders, Beijing, China
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Neil Davie
12Global Clinical Development, Bayer HealthCare Pharmaceuticals, Wuppertal, Germany
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Arno Fritsch
12Global Clinical Development, Bayer HealthCare Pharmaceuticals, Wuppertal, Germany
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Hossein-Ardeschir Ghofrani
13Department of Internal Medicine, University of Giessen and Marburg Lung Center (UGMLC), Member of the German Center of Lung Research (DZL), Giessen, Germany
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Abstract

Background

PEA is the recommended treatment for CTEPH as it is potentially curative in the majority of patients (pts). However, some pts have persistent/recurrent pulmonary hypertension (PH) following PEA.

Aims

This subgroup analysis of the CHEST study assessed the long-term effects of riociguat in pts with persistent/recurrent PH following PEA.

Methods

In CHEST-1, 72 pts with persistent/recurrent PH following PEA were randomized to riociguat (up to 2.5 mg tid) or placebo (pbo) for 16 wks. After CHEST-1 completion, eligible pts could enter the long-term extension study CHEST-2, where all pts received riociguat. The results of an interim analysis (censored Mar 2013) are reported.

Results

At the end of CHEST-1, 6MWD and several secondary endpoints had improved in the riociguat group vs pbo. Of the 72 pts with persistent/recurrent PH following PEA in CHEST-1, 65 entered CHEST-2 (mean age 58±15 yrs, mean time since PEA 3.3 yrs). At censor date, 86% (n=56) of pts were ongoing, 69% (n=45) attended the 1-yr visit, and 14% (n=9) had discontinued, of whom 8% (n=5) had died. Riociguat was well tolerated; 2% (n=1) of pts withdrew due to adverse events. Improvements in 6MWD at Wk 12 of CHEST-2 vs CHEST-1 baseline (ex-riociguat 40±75 m; ex-pbo 44±43 m) were sustained for 1 yr in the overall cohort (44±64 m; n=42). WHO functional class improved/stabilized/worsened in 42/53/4% and 42/58/0% of the ex-riociguat and ex-pbo pts, respectively, at Wk 12 of CHEST-2, and 49/51/0% of pts at 1 yr (n=43).

Conclusions

Long-term riociguat was well tolerated in pts with persistent/recurrent PH following PEA and improved 6MWD and secondary endpoints for up to 1 yr.

  • Pulmonary hypertension
  • © 2014 ERS
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Effects of riociguat in patients with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) following pulmonary endarterectomy (PEA)
Eckhard Mayer, Andrzej Biederman, Andrea M. D'Armini, Ekkehard Grünig, Pavel Jansa, David P. Jenkins, Nick H. Kim, Walter Klepetko, Jaroslav Lindner, Michael M. Madani, Chen Wang, Neil Davie, Arno Fritsch, Hossein-Ardeschir Ghofrani
European Respiratory Journal Sep 2014, 44 (Suppl 58) 3421;

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Effects of riociguat in patients with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) following pulmonary endarterectomy (PEA)
Eckhard Mayer, Andrzej Biederman, Andrea M. D'Armini, Ekkehard Grünig, Pavel Jansa, David P. Jenkins, Nick H. Kim, Walter Klepetko, Jaroslav Lindner, Michael M. Madani, Chen Wang, Neil Davie, Arno Fritsch, Hossein-Ardeschir Ghofrani
European Respiratory Journal Sep 2014, 44 (Suppl 58) 3421;
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