doi: 10.1016/j.rmed.2020.106220.
Epub 2020 Nov 12.
Riociguat treatment in patients with chronic thromboembolic pulmonary hypertension: Final safety data from the EXPERT registry
Hossein-Ardeschir Ghofrani
1
, Miguel-Angel Gomez Sanchez
2
, Marc Humbert
3
, David Pittrow
4
, Gérald Simonneau
5
, Henning Gall
6
, Ekkehard Grünig
7
, Hans Klose
8
, Michael Halank
9
, David Langleben
10
, Repke J Snijder
11
, Pilar Escribano Subias
12
, Lisa M Mielniczuk
13
, Tobias J Lange
14
, Jean-Luc Vachiéry
15
, Hubert Wirtz
16
, Douglas S Helmersen
17
, Iraklis Tsangaris
18
, Joan A Barberá
19
, Joanna Pepke-Zaba
20
, Anco Boonstra
21
, Stephan Rosenkranz
22
, Silvia Ulrich
23
, Regina Steringer-Mascherbauer
24
, Marion Delcroix
25
, Pavel Jansa
26
, Iveta Šimková
27
, George Giannakoulas
28
, Jens Klotsche
29
, Evgenia Williams
30
, Christian Meier
30
, Marius M Hoeper
31
; NEW COLLABORATORS LIST
Collaborators,
Affiliations
Collaborators
-
NEW COLLABORATORS LIST:
Jorge Caneva 32 , Graciela Tuhay 32 , Mirta Diez 33 , Maria Lujan Talavera 33 , Adriana Acosta 33 , Norberto Vulcano 34 , Martin Bosio 35 , Lorena Maldonado 35 , Sabino Deleo 36 , Luciano Melatini 37 , Anne Keogh 38 , Eugene Kotlyar 38 , John Feenstra 39 , Nathan Dwyer 40 , Heath Adams 40 , Wendy Stevens 41 , Peter Steele 42 , Susanna Proudman 42 , Robert Minson 43 , Glenn Reeves 44 , Melanie Lavender 45 , Benjamin Ng 46 , Michele Mackenzie 46 , Lisa Barry 46 , Margarethe Gruenberger 24 , Charlotte Huber 24 , Irene Lang 47 , Ioana Tilea 47 , Roela Sadushi-Kolici 47 , Judith Löffler-Ragg 48 , Lisa-Theresa Feistmantl 48 , Patrick Evrard 49 , Renaud Louis 50 , Julien Guiot 50 , Marco Naldi 50 , Michel De Pauw 51 , Sanjay Mehta 52 , Rafael Conde Camacho 53 , Patricia Parada Tovar 53 , Alejandro Londoño 54 , Felipe Campo 54 , Paula Garcia 54 , Camila Lema 54 , Mauricio Orozco-Levi 55 , William Martinez 56 , Juan Esteban Gomez 56 , Jens Erik Nielsen-Kudsk 57 , Soren Mellemkjaer 57 , Ly Anton 58 , Alan Altraja 59 , Tapani Vihinen 60 , Tuija Vasankari 60 , Olivier Sitbon 61 , Vincent Cottin 62 , Laurent Têtu 63 , Elise Noël-Savina 63 , Nicole Shearman 31 , Susanne Tayler 31 , Ilona Olzik 31 , Christine Kulka 64 , Jan Grimminger 8 , Marcel Simon 8 , Anna Nolde 8 , Tim Oqueka 8 , Lars Harbaum 8 , Benjamin Egenlauf 65 , Ralf Ewert 66 , Christian Schulz 14 , Sabine Regotta 14 , Tilmann Kramer 22 , Susanne Knoop-Busch 22 , Felix Gerhardt 22 , Stavros Konstantinides 67 , Georgia Pitsiou 68 , Ioannis Stanopoulos 68 , Evdokia Sourla 68 , Sofia Mouratoglou 28 , Haralambos Karvounis 28 , Athanasios Pappas 18 , Dimitrios Georgopoulos 69 , Michail Fanaridis 69 , Ioanna Mitrouska 69 , Lampros Michalis 70 , Konstantinos Pappas 71 , Anna Kotsia 71 , Sean Gaine 72 , Carmine Dario Vizza 73 , Giovanna Manzi 73 , Roberto Poscia 73 , Roberto Badagliacca 73 , Piergiuseppe Agostoni 74 , Noemi Bruno 74 , Stefania Farina 74 , Michele D'Alto 75 , Paola Argiento 75 , Anna Correra 75 , Giovanni Maria Di Marco 75 , Chiara Cresci 76 , Vieri Vannucchi 76 , Elena Torricelli 76 , Alessio Garcea 76 , Alberto Pesci 77 , Luca Sardella 77 , Giuseppe Paciocco 77 , Federico Pane 77 , Andrea Maria D'Armini 78 , Maurizio Pin 78 , Valentina Grazioli 78 , Giulia Massola 78 , Antonio Sciortino 78 , Renato Prediletto 79 , Carolina Bauleo 79 , Edoardo Airò 79 , Rudina Ndreu 79 , Ivana Pavlickova 79 , Claudio Lunardi 80 , Massimiliano Mulè 81 , Silvia Farruggio 81 , Serena Costa 81 , Giuseppe Galgano 82 , Mario Petruzzi 82 , Anna De Luca 82 , Francesco Lombardi 82 , Loris Roncon 83 , Luca Conte 83 , Claudio Picariello 83 , Gil Wirtz 84 , Myriam Alexandre 84 , A Vonk-Noordegraaf 21 , H Boogaard 21 , J Mager 11 , H Reesink 11 , Leon M van den Toorn 85 , Karin Boomars 85 , Arne K Andreassen 86 , Graça Castro 87 , Gonçalves Tania 87 , Rui Baptista 87 , António Marinho 87 , Teresa Shiang 88 , Ana Oliveira 88 , Daniel Coutinho 88 , Joana Sousa 88 , Maria José Loureiro 89 , Débora Repolho 89 , Susana Maria Martins Jesus 90 , Marta Capinha 90 , João Agostinho 90 , Tania Cardoso 90 , Andreia Rocha 90 , Mafalda Espinha 90 , Kyundyul Ivanovich Ivanov 91 , Dalyana Eduardovna Alexeeva 91 , Marina Vadimovna Batalina 92 , Daria Viktorovna Hegya 93 , Tatyana Nikolaevna Zvereva 94 , Sergey Nikolaevich Avdeev 95 , Natalia Anatolievna Tsareva 95 , Albert Sarvatovich Galyavich 96 , Bykov Aleksander Nikolaevich 97 , Evgeny Vladimirovich Filippov 98 , Olga Eduardovna Yakovleva 99 , Olga Borisovna Pavlova 100 , Elena Sergeevna Skripkina 101 , Tamila Vitalievna Martynyuk 102 , Irina Fedorovna Bukatova 103 , Anna Viktorovna Tregubova 104 , Dmitry Yurievich Platonov 105 , Tatyana Mikhaylovna Kolomeytseva 106 , Abdullah Al Dalaan 107 , Abeer Abeer Abdelsayed 107 , Ihab Weheba 107 , Sarferaz Saleemi 107 , Hussam Sakkijha 108 , Marcela Bohacekova 27 , Tatiana Valkovicova 27 , Iveta Farkasova 27 , Carlos Andres Quezada 109 , Lucilla Piccari 110 , Isabel Blanco 110 , Laura Sebastian 110 , Antonio Roman 111 , Manuel Lopez 111 , Remedios Otero 112 , Teresa Elias 112 , Luis Jara 112 , Isabel Asencio 112 , Josefa Jiménez Arjona 113 , Raúl Menor Almagro 113 , Salvador López Cárdenas 113 , Salvador Alcaraz García 113 , Patricia Villanueva Rodríguez 113 , Raquel Lopez 114 , Alberto Garcia 114 , Francisco Fernandez Avilés 115 , Sebastian De La Pava 115 , Raquel Yotti 115 , Gregorio Pérez Peñate 116 , Fernando León Marrero 116 , José Manuel Cifrián Martínez 117 , Amaya Martinez-Meñaca 117 , Lecue Pilar Alonso 117 , Sonia Fernandez Rozas 117 , David Iturbe Fernandez 117 , Victor Mora Cuesta 117 , Stefan Söderberg 118 , Sven-Erik Bartfay 119 , Bengt Rundqvist 119 , Monthir Alfetlawi 120 , Peter Wodlin 120 , Esther Irene Schwarz 23 , Rudolf Speich 23 , Frédéric Lador 121 , Thierry Rochat 121 , Paola Gasche-Soccal 121 , Chih-Hsin Hsu 122 , Tsung-Hsien Lin 123 , Ho-Ming Su 123 , Wen-Ter Lai 123 , Chun Yuan Chu 123 , Po-Chao Hsu 123 , Wen-Chol Voon 123 , Hsueh-Wei Yen 123 , Jacob Yih-Jer Wu 124 , Shu-Hao Wu 124 , Wen-Pin Huang 125 , Man-Cai Fong 125 , Chien-Lung Huang 125 , Ping-Hung Kuo 126 , Yen-Hung Lin 126 , Jiunn-Lee Lin 126 , Chi-Sheng Hung 126 , Cho-Kai Wu 126 , Shih-Hsien Sung 127 , Wei-Chun Huang 128 , Chin-Chang Cheng 128 , Shu-Hung Kuo 128 , Wen-Hwa Wang 128 , Wan-Jing Ho 129 , Tsu-Shiu Hsu 129 , Bülent Mutlu 130 , Halil Atas 130 , Gul Ongen 131 , Zeynep Un 131 , Gulfer Okumus 132 , Zeynep Un 132 , Ismail Hanta 133 , Paul Corris 134 , Andrew Peacock 135 , Colin Church 135 , Mark Toshner 136 , Michael Newnham 136
Affiliations
- 1 University of Giessen and Marburg Lung Center (UGMLC), Giessen, Germany; Member of the German Center for Lung Research (DZL), Giessen, Germany. Electronic address: Ardeschir.Ghofrani@innere.med.uni-giessen.de.
- 2 Respiratory Department, Ramón y Cajal University Hospital (IRYCIS), Madrid, Spain; Biomedical Research Networking Centre on Respiratory Diseases (CIBERES), Spain.
- 3 Université Paris-Saclay, Inserm U999, Service de Pneumologie et Soins Intensifs Respiratoires, Hôpital Bicêtre, Le Kremlin-Bicêtre, France.
- 4 Institute for Clinical Pharmacology, Technical University, Dresden, Germany.
- 5 Université Paris-Sud, Le Kremlin-Bicêtre, Service de Pneumologie, Centre de Référence de l'Hypertension Pulmonaire Sévère, DHU Thorax Innovation, Hôpital Bicêtre, Le Kremlin-Bicêtre, Paris, France.
- 6 University of Giessen and Marburg Lung Center (UGMLC), Giessen, Germany; Member of the German Center for Lung Research (DZL), Giessen, Germany.
- 7 Centre for Pulmonary Hypertension, Thoraxclinic at Heidelberg University Hospital, Heidelberg, Germany.
- 8 Department of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
- 9 Medical Clinic I, Department of Pneumology, University Hospital Carl Gustav Carus, Dresden, Germany.
- 10 Center for Pulmonary Vascular Disease, Jewish General Hospital, McGill University, Montreal, Quebec, Canada.
- 11 Department of Pulmonology, St Antonius Ziekenhuis, Nieuwegein, the Netherlands.
- 12 Department of Cardiology, Hospital 12 de Octubre, Madrid, Spain; CIBER-CV (CIBER of Cardiovascular Disease), Hospital 12 de Octubre, Madrid, Spain.
- 13 Division of Cardiology, Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.
- 14 Department of Internal Medicine II, Division of Pneumology, University Medical Center, Regensburg, Germany.
- 15 Département de Cardiologie, Cliniques Universitaires de Bruxelles, Hôpital Erasme, Brussels, Belgium.
- 16 Department of Respiratory Medicine, University of Leipzig, Leipzig, Germany.
- 17 Alberta Health Services, University of Calgary, Calgary, Alberta, Canada.
- 18 Second Department of Critical Care, University Hospital Attikon, National and Kapodistrian University of Athens, Athens, Greece.
- 19 Hospital Clínic-IDIBAPS, University of Barcelona, Barcelona, Spain; Biomedical Research Networking Center on Respiratory Diseases (CIBERES), Madrid, Spain.
- 20 Pulmonary Vascular Disease Unit, Royal Papworth Hospital, Cambridge, UK.
- 21 VU Medisch Centrum, Amsterdam, the Netherlands.
- 22 Department III of Internal Medicine and Cologne Cardiovascular Research Center (CCRC), Cologne University Heart Center, Cologne, Germany.
- 23 Clinic of Pulmonology, University Hospital Zurich, Zurich, Switzerland.
- 24 Servicestelle für klinische Studien, Krankenhaus der Elisabethinen Linz GmbH, Linz, Austria.
- 25 Department of Respiratory Diseases, University Hospitals of Leuven, and Respiratory Division, Department CHROMETA, KU Leuven - University of Leuven, Leuven, Belgium.
- 26 2(nd) Department of Medicine, Department of Cardiovascular Medicine, Charles University in Prague, Prague, Czech Republic.
- 27 Department of Cardiology and Angiology, Faculty of Medicine, Slovak Medical University & National Institute of Cardiovascular Diseases, Bratislava, Slovak Republic.
- 28 Department of Cardiology I, Aristotle University of Thessaloniki, Thessaloniki, Greece.
- 29 German Rheumatism Research Center Berlin, Leibniz Institute, Berlin, Germany.
- 30 Bayer AG, Global Development, Global Medical Affairs, Berlin, Germany.
- 31 Department of Respiratory Medicine and the German Center for Lung Research, Hannover Medical School, Hannover, Germany.
- 32 Pneumonology Service, Hospital Universitario Fundación Favaloro, Buenos Aires, Argentina.
- 33 Clinical Cardiology Service, ICBA - Instituto Cardiovascular de Buenos Aires, Buenos Aires, Argentina.
- 34 Department of Cardiology, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
- 35 Center for Respiratory Medicine, Hospital Británico, Buenos Aires, Argentina.
- 36 Pneumonology, Cen Asma Centro de Enfermedades Respiratorias, Buenos Aires, Argentina.
- 37 Pneumonology, Instituto Diagnostico, Buenos Aires, Argentina.
- 38 Heart Lung Clinic, St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia.
- 39 Queensland Lung Transplant Service (QLTS), Prince Charles Hospital, Chermside, QLD, Australia.
- 40 Department of Cardiology, Royal Hobart Hospital, Hobart, Tasmania, Australia.
- 41 Rheumatology Department, St Vincent's Hospital, Melbourne, Victoria, Australia.
- 42 Clinical Trials Centre, Cardiology Service, Royal Adelaide Hospital, Adelaide, South Australia, Australia.
- 43 Flinders Cardiac Clinic, Flinders Medical Centre, Bedford Park, South Australia, Australia.
- 44 Immunology Department, John Hunter Hospital, Newcastle, New South Wales, Australia.
- 45 Advanced Lung Disease Unit, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.
- 46 Nepean Hospital, Kingswood, New South Wales, Australia.
- 47 Clinical Department of Cardiology, Medical University of Vienna, Vienna, Austria.
- 48 Department of Internal Medicine II, Medical University of Innsbruck, Innsbruck, Austria.
- 49 Department of Intensive Care, Centre Hospitalier Université Dinant-Mont-Godinne, Yvoir, Belgium.
- 50 Department of Pulmonary Medicine, Centre Hospitalier Université Liège, Liège, Belgium.
- 51 Department of Internal Medicine and Pediatrics, Ghent University Hospital, Ghent, Belgium.
- 52 Centre for Critical Illness Research, Lawson Health Research Institute, London, Ontario, Canada.
- 53 Internal Medicine and Pneumonology, Fundación Neumológica, Bogotá, Colombia.
- 54 Pneumonology Department, Clínica Cardio, VID, Medellin, Colombia.
- 55 Pneumonology Service, Fundación Cardiovascular de Colombia, Floridablanca, Santander, Colombia.
- 56 Valle de Lili Foundation, Cali, Colombia.
- 57 Department of Clinical Medicine, Aarhus University Hospital Skejby, Aarhus, Denmark.
- 58 Centre of Cardiology, North Estonia Medical Centre Foundation, Tallinn, Estonia.
- 59 Department of Pulmonology, Tartu University Hospital, Tartu, Estonia.
- 60 Heart Center, Sydänkeskus Turku University Hospital, Turku, Finland.
- 61 Hôpital Bicêtre, Le Kremlin-Bicêtre, France.
- 62 National Reference Centre for Rare Pulmonary Diseases, Hôpital Louis Pradel, Lyon, France.
- 63 Pneumonology Service, Hôpital Larrey, Toulouse, France.
- 64 Department of Pneumology, University Hospital Carl Gustav Carus, Dresden, Germany.
- 65 Centre for Pulmonary Hypertension, Thoraxklinik at Heidelberg University Hospital, Heidelberg, Germany.
- 66 Department of Internal Medicine, Clinic and Polyclinic for Internal Medicine B, Greifswald, Germany.
- 67 Center for Thrombosis and Hemostasis, University Medical Center of the Johannes Gutenberg University, Mainz, Germany.
- 68 Respiratory Insufficiency Unit, "G. Papanikolaou" General Hospital of Thessaloniki, Thessaloniki, Greece.
- 69 Department of Intensive Care Medicine, University Hospital of Heraklion, Heraklion, Greece.
- 70 2nd Department of Cardiology, University Hospital of Ioannina, Ioannina, Greece.
- 71 Division of Cardiology, University Hospital of Ioannina, Ioannina, Greece.
- 72 National Pulmonary Hypertension Unit, Mater Misericordiae University Hospital, Dublin, Ireland.
- 73 Policlinico Umberto I, Department of Cardiovascular, Respiratory, Nephrological, Anaesthesiological, and Geriatric Sciences, La Sapienza Hospital, Rome, Italy.
- 74 Monzino Cardiology Center Hospital, Milan, Italy.
- 75 Department of Cardiology, Monaldi Hospital, Naples, Italy.
- 76 Pneumology Unit, Careggi University Hospital, Florence, Italy.
- 77 Pneumology Clinic, Cardiothoracic and Vascular Department, San Gerardo Hospital, Monza, Italy.
- 78 Cardiothoracic and Vascular Department, Policlinico San Matteo, Pavia, Italy.
- 79 Institute of Clinical Physiology, Toscana Gabriele Monasterio Foundation, CNR Research Area, Pisa, Italy.
- 80 Department of Medicine, Integrated University Hospital Verona, Verona, Italy.
- 81 Department of Cardiology, Policlinico Vittorio Emanuele, Catania, Italy.
- 82 Division of Cardiology, Miulli General Hospital, Fonti-Bari, Italy.
- 83 Department of Cardiology, Hospital Santa Maria della Misericordia, Rovigo, Italy.
- 84 Pneumology Service, Centre Hospitalier de Luxembourg, Luxembourg.
- 85 Department of Pulmonary Diseases, Erasmus Medical Centre, Rotterdam, the Netherlands.
- 86 Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.
- 87 Department of Cardiology, Coimbra Hospital and University Center, Coimbra, Portugal.
- 88 Department of Pneumology, Hospital Center Vila Nova de Gaia/Espinho, Vila Nova de Gaia, Portugal.
- 89 Cardiology Department, Hospital Garcia de Orta, E.P.E., Almada, Portugal.
- 90 Department of Medicine I, North Lisbon Hospital Center, Lisbon, Portugal.
- 91 State Budgetary Institution of the Republic of Sakha (Yakutia) "Republican Hospital №1 - National Center for Medicine", Yakutsk, Russia.
- 92 State Educational Institution of Higher Professional Education "Orenburg State Medical University", Orenburg, Russia.
- 93 State Budgetary Healthcare Institution "Primorskaya Regional Clinical Hospital №1", Vladivostok, Russia.
- 94 Federal State Budgetary Scientific Institution "Research Institute for Complex Problems of Cardiovascular Diseases", Kemerovo, Russia.
- 95 Federal State Budgetary Institution "Scientific Research Institute of Pulmonology of the Federal Bio-Medical Agency", Moscow, Russia.
- 96 State Budgetary Institution of High Professional Education "Kazan State Medical University", Kazan, Russia.
- 97 State Budgetary Healthcare Institution "Sverdlovsk Regional Clinical Hospital No.1", Yekaterinburg, Russia.
- 98 State Budget Institution of the Ryazan Region "Regional Clinical Cardiology Dispensary", Ryazan, Russia.
- 99 Chelyabinsk Regional Cardiology Clinic, Chelyabinsk, Russia.
- 100 Perm Regional State Budgetary Healthcare Institution "Clinical Cardiologic Dispensary", Perm, Russia.
- 101 State Autonomous Healthcare Institution Amur Region "Amur Regional Clinical Hospital", Blagoveschensk, Russia.
- 102 Federal State Budget Institution "Russian Cardiology Research and Production Complex" of the Russian Federation, Moscow, Russia.
- 103 Regional State Budgetary Healthcare Institution "Regional Clinical Hospital №1", Khabarovsk, Russia.
- 104 State Budgetary Healthcare Institution "Volgograd Regional Clinical Cardiology Center", Volgograd, Russia.
- 105 State Budgetary Healthcare Institution "Regional Clinical Hospital", Tver, Russia.
- 106 State Healthcare Institution "City Hospital No.13 in Tula", Tula, Russia.
- 107 Pulmonary Medicine Section, Department of Medicine, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia.
- 108 Pulmonary Medicine, King Fahad Medical City, Riyadh, Saudi Arabia.
- 109 Department of Cardiology, Hospital 12 de Octubre, Madrid, Spain.
- 110 Hospital Clínic-IDIBAPS, University of Barcelona, Barcelona, Spain.
- 111 Department of Medicine, Hospital Vall Hebron, Barcelona, Spain.
- 112 Medical-Surgical Unit of Respiratory Diseases, University Hospital Virgen Del Rocio, Seville, Spain.
- 113 Department of Internal Medicine, Hospital De Jerez, Jerez De La Frontera, Spain.
- 114 Pneumology Department, Hospital La Fe, Valencia, Spain.
- 115 Department of Cardiology, Hospital Gregorio Marañon, Madrid, Spain.
- 116 Pneumology Service, Hospital Dr Negrin, Las Palmas, Spain.
- 117 Servicio de Anestesiología y Reanimación, Hospital Marques de Valdecilla, Santander, Spain.
- 118 Heart Center, Norrland University Hospital, Umeå, Sweden.
- 119 Department of Cardiology, Sahlgrenska University Hospital, Göteborg, Sweden.
- 120 Department of Cardiology, Linköping University Hospital, Linköping, Sweden.
- 121 Pulmonary Division, Geneva University Hospitals, Geneva, Switzerland.
- 122 Department of Internal Medicine, National Cheng Kung University Hospital, Tainan City, Taiwan.
- 123 Department of Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan.
- 124 Cardiovascular Center, Mackay Memorial Hospital, Taipei City, Taiwan.
- 125 Division of Cardiology, Heart Center, Cheng Hsin General Hospital, Taipei City, Taiwan.
- 126 Department of Internal Medicine, National Taiwan University Hospital, Taipei City, Taiwan.
- 127 Department of Medicine, Taipei Veterans General Hospital, Taipei City, Taiwan.
- 128 Department of Cardiology, Kaohsiung Veterans General Hospital, Kaohsiung City, Taiwan.
- 129 Department of Internal Medicine, Chang Gung Memorial Hospital, Linkou, Taoyuan County, Taiwan.
- 130 Department of Cardiology, Marmara University Faculty of Medicine, Istanbul, Turkey.
- 131 Department of Chest Diseases, Istanbul University Cerrahpasa Faculty of Medicine, Istanbul, Turkey.
- 132 Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey.
- 133 Department of Respiratory Medicine, Cukurova University, Adana, Turkey.
- 134 Department of Respiratory Medicine, Freeman Hospital, Newcastle, United Kingdom.
- 135 Scottish Pulmonary Vascular Unit, Golden Jubilee National Hospital, Clydebank, West Dunbartonshire, United Kingdom.
- 136 Pulmonary Vascular Disease Unit, Royal Papworth Hospital, Cambridge, United Kingdom.
- PMID: 33540340
- DOI: 10.1016/j.rmed.2020.106220
Item in Clipboard
Riociguat treatment in patients with chronic thromboembolic pulmonary hypertension: Final safety data from the EXPERT registry
Hossein-Ardeschir Ghofrani et al.
Respir Med.
2021 Mar.
Free article
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Format
doi: 10.1016/j.rmed.2020.106220.
Epub 2020 Nov 12.
Authors
Hossein-Ardeschir Ghofrani
1
, Miguel-Angel Gomez Sanchez
2
, Marc Humbert
3
, David Pittrow
4
, Gérald Simonneau
5
, Henning Gall
6
, Ekkehard Grünig
7
, Hans Klose
8
, Michael Halank
9
, David Langleben
10
, Repke J Snijder
11
, Pilar Escribano Subias
12
, Lisa M Mielniczuk
13
, Tobias J Lange
14
, Jean-Luc Vachiéry
15
, Hubert Wirtz
16
, Douglas S Helmersen
17
, Iraklis Tsangaris
18
, Joan A Barberá
19
, Joanna Pepke-Zaba
20
, Anco Boonstra
21
, Stephan Rosenkranz
22
, Silvia Ulrich
23
, Regina Steringer-Mascherbauer
24
, Marion Delcroix
25
, Pavel Jansa
26
, Iveta Šimková
27
, George Giannakoulas
28
, Jens Klotsche
29
, Evgenia Williams
30
, Christian Meier
30
, Marius M Hoeper
31
; NEW COLLABORATORS LIST
Collaborators
-
NEW COLLABORATORS LIST:
Jorge Caneva 32 , Graciela Tuhay 32 , Mirta Diez 33 , Maria Lujan Talavera 33 , Adriana Acosta 33 , Norberto Vulcano 34 , Martin Bosio 35 , Lorena Maldonado 35 , Sabino Deleo 36 , Luciano Melatini 37 , Anne Keogh 38 , Eugene Kotlyar 38 , John Feenstra 39 , Nathan Dwyer 40 , Heath Adams 40 , Wendy Stevens 41 , Peter Steele 42 , Susanna Proudman 42 , Robert Minson 43 , Glenn Reeves 44 , Melanie Lavender 45 , Benjamin Ng 46 , Michele Mackenzie 46 , Lisa Barry 46 , Margarethe Gruenberger 24 , Charlotte Huber 24 , Irene Lang 47 , Ioana Tilea 47 , Roela Sadushi-Kolici 47 , Judith Löffler-Ragg 48 , Lisa-Theresa Feistmantl 48 , Patrick Evrard 49 , Renaud Louis 50 , Julien Guiot 50 , Marco Naldi 50 , Michel De Pauw 51 , Sanjay Mehta 52 , Rafael Conde Camacho 53 , Patricia Parada Tovar 53 , Alejandro Londoño 54 , Felipe Campo 54 , Paula Garcia 54 , Camila Lema 54 , Mauricio Orozco-Levi 55 , William Martinez 56 , Juan Esteban Gomez 56 , Jens Erik Nielsen-Kudsk 57 , Soren Mellemkjaer 57 , Ly Anton 58 , Alan Altraja 59 , Tapani Vihinen 60 , Tuija Vasankari 60 , Olivier Sitbon 61 , Vincent Cottin 62 , Laurent Têtu 63 , Elise Noël-Savina 63 , Nicole Shearman 31 , Susanne Tayler 31 , Ilona Olzik 31 , Christine Kulka 64 , Jan Grimminger 8 , Marcel Simon 8 , Anna Nolde 8 , Tim Oqueka 8 , Lars Harbaum 8 , Benjamin Egenlauf 65 , Ralf Ewert 66 , Christian Schulz 14 , Sabine Regotta 14 , Tilmann Kramer 22 , Susanne Knoop-Busch 22 , Felix Gerhardt 22 , Stavros Konstantinides 67 , Georgia Pitsiou 68 , Ioannis Stanopoulos 68 , Evdokia Sourla 68 , Sofia Mouratoglou 28 , Haralambos Karvounis 28 , Athanasios Pappas 18 , Dimitrios Georgopoulos 69 , Michail Fanaridis 69 , Ioanna Mitrouska 69 , Lampros Michalis 70 , Konstantinos Pappas 71 , Anna Kotsia 71 , Sean Gaine 72 , Carmine Dario Vizza 73 , Giovanna Manzi 73 , Roberto Poscia 73 , Roberto Badagliacca 73 , Piergiuseppe Agostoni 74 , Noemi Bruno 74 , Stefania Farina 74 , Michele D'Alto 75 , Paola Argiento 75 , Anna Correra 75 , Giovanni Maria Di Marco 75 , Chiara Cresci 76 , Vieri Vannucchi 76 , Elena Torricelli 76 , Alessio Garcea 76 , Alberto Pesci 77 , Luca Sardella 77 , Giuseppe Paciocco 77 , Federico Pane 77 , Andrea Maria D'Armini 78 , Maurizio Pin 78 , Valentina Grazioli 78 , Giulia Massola 78 , Antonio Sciortino 78 , Renato Prediletto 79 , Carolina Bauleo 79 , Edoardo Airò 79 , Rudina Ndreu 79 , Ivana Pavlickova 79 , Claudio Lunardi 80 , Massimiliano Mulè 81 , Silvia Farruggio 81 , Serena Costa 81 , Giuseppe Galgano 82 , Mario Petruzzi 82 , Anna De Luca 82 , Francesco Lombardi 82 , Loris Roncon 83 , Luca Conte 83 , Claudio Picariello 83 , Gil Wirtz 84 , Myriam Alexandre 84 , A Vonk-Noordegraaf 21 , H Boogaard 21 , J Mager 11 , H Reesink 11 , Leon M van den Toorn 85 , Karin Boomars 85 , Arne K Andreassen 86 , Graça Castro 87 , Gonçalves Tania 87 , Rui Baptista 87 , António Marinho 87 , Teresa Shiang 88 , Ana Oliveira 88 , Daniel Coutinho 88 , Joana Sousa 88 , Maria José Loureiro 89 , Débora Repolho 89 , Susana Maria Martins Jesus 90 , Marta Capinha 90 , João Agostinho 90 , Tania Cardoso 90 , Andreia Rocha 90 , Mafalda Espinha 90 , Kyundyul Ivanovich Ivanov 91 , Dalyana Eduardovna Alexeeva 91 , Marina Vadimovna Batalina 92 , Daria Viktorovna Hegya 93 , Tatyana Nikolaevna Zvereva 94 , Sergey Nikolaevich Avdeev 95 , Natalia Anatolievna Tsareva 95 , Albert Sarvatovich Galyavich 96 , Bykov Aleksander Nikolaevich 97 , Evgeny Vladimirovich Filippov 98 , Olga Eduardovna Yakovleva 99 , Olga Borisovna Pavlova 100 , Elena Sergeevna Skripkina 101 , Tamila Vitalievna Martynyuk 102 , Irina Fedorovna Bukatova 103 , Anna Viktorovna Tregubova 104 , Dmitry Yurievich Platonov 105 , Tatyana Mikhaylovna Kolomeytseva 106 , Abdullah Al Dalaan 107 , Abeer Abeer Abdelsayed 107 , Ihab Weheba 107 , Sarferaz Saleemi 107 , Hussam Sakkijha 108 , Marcela Bohacekova 27 , Tatiana Valkovicova 27 , Iveta Farkasova 27 , Carlos Andres Quezada 109 , Lucilla Piccari 110 , Isabel Blanco 110 , Laura Sebastian 110 , Antonio Roman 111 , Manuel Lopez 111 , Remedios Otero 112 , Teresa Elias 112 , Luis Jara 112 , Isabel Asencio 112 , Josefa Jiménez Arjona 113 , Raúl Menor Almagro 113 , Salvador López Cárdenas 113 , Salvador Alcaraz García 113 , Patricia Villanueva Rodríguez 113 , Raquel Lopez 114 , Alberto Garcia 114 , Francisco Fernandez Avilés 115 , Sebastian De La Pava 115 , Raquel Yotti 115 , Gregorio Pérez Peñate 116 , Fernando León Marrero 116 , José Manuel Cifrián Martínez 117 , Amaya Martinez-Meñaca 117 , Lecue Pilar Alonso 117 , Sonia Fernandez Rozas 117 , David Iturbe Fernandez 117 , Victor Mora Cuesta 117 , Stefan Söderberg 118 , Sven-Erik Bartfay 119 , Bengt Rundqvist 119 , Monthir Alfetlawi 120 , Peter Wodlin 120 , Esther Irene Schwarz 23 , Rudolf Speich 23 , Frédéric Lador 121 , Thierry Rochat 121 , Paola Gasche-Soccal 121 , Chih-Hsin Hsu 122 , Tsung-Hsien Lin 123 , Ho-Ming Su 123 , Wen-Ter Lai 123 , Chun Yuan Chu 123 , Po-Chao Hsu 123 , Wen-Chol Voon 123 , Hsueh-Wei Yen 123 , Jacob Yih-Jer Wu 124 , Shu-Hao Wu 124 , Wen-Pin Huang 125 , Man-Cai Fong 125 , Chien-Lung Huang 125 , Ping-Hung Kuo 126 , Yen-Hung Lin 126 , Jiunn-Lee Lin 126 , Chi-Sheng Hung 126 , Cho-Kai Wu 126 , Shih-Hsien Sung 127 , Wei-Chun Huang 128 , Chin-Chang Cheng 128 , Shu-Hung Kuo 128 , Wen-Hwa Wang 128 , Wan-Jing Ho 129 , Tsu-Shiu Hsu 129 , Bülent Mutlu 130 , Halil Atas 130 , Gul Ongen 131 , Zeynep Un 131 , Gulfer Okumus 132 , Zeynep Un 132 , Ismail Hanta 133 , Paul Corris 134 , Andrew Peacock 135 , Colin Church 135 , Mark Toshner 136 , Michael Newnham 136
Affiliations
- 1 University of Giessen and Marburg Lung Center (UGMLC), Giessen, Germany; Member of the German Center for Lung Research (DZL), Giessen, Germany. Electronic address: Ardeschir.Ghofrani@innere.med.uni-giessen.de.
- 2 Respiratory Department, Ramón y Cajal University Hospital (IRYCIS), Madrid, Spain; Biomedical Research Networking Centre on Respiratory Diseases (CIBERES), Spain.
- 3 Université Paris-Saclay, Inserm U999, Service de Pneumologie et Soins Intensifs Respiratoires, Hôpital Bicêtre, Le Kremlin-Bicêtre, France.
- 4 Institute for Clinical Pharmacology, Technical University, Dresden, Germany.
- 5 Université Paris-Sud, Le Kremlin-Bicêtre, Service de Pneumologie, Centre de Référence de l'Hypertension Pulmonaire Sévère, DHU Thorax Innovation, Hôpital Bicêtre, Le Kremlin-Bicêtre, Paris, France.
- 6 University of Giessen and Marburg Lung Center (UGMLC), Giessen, Germany; Member of the German Center for Lung Research (DZL), Giessen, Germany.
- 7 Centre for Pulmonary Hypertension, Thoraxclinic at Heidelberg University Hospital, Heidelberg, Germany.
- 8 Department of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
- 9 Medical Clinic I, Department of Pneumology, University Hospital Carl Gustav Carus, Dresden, Germany.
- 10 Center for Pulmonary Vascular Disease, Jewish General Hospital, McGill University, Montreal, Quebec, Canada.
- 11 Department of Pulmonology, St Antonius Ziekenhuis, Nieuwegein, the Netherlands.
- 12 Department of Cardiology, Hospital 12 de Octubre, Madrid, Spain; CIBER-CV (CIBER of Cardiovascular Disease), Hospital 12 de Octubre, Madrid, Spain.
- 13 Division of Cardiology, Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.
- 14 Department of Internal Medicine II, Division of Pneumology, University Medical Center, Regensburg, Germany.
- 15 Département de Cardiologie, Cliniques Universitaires de Bruxelles, Hôpital Erasme, Brussels, Belgium.
- 16 Department of Respiratory Medicine, University of Leipzig, Leipzig, Germany.
- 17 Alberta Health Services, University of Calgary, Calgary, Alberta, Canada.
- 18 Second Department of Critical Care, University Hospital Attikon, National and Kapodistrian University of Athens, Athens, Greece.
- 19 Hospital Clínic-IDIBAPS, University of Barcelona, Barcelona, Spain; Biomedical Research Networking Center on Respiratory Diseases (CIBERES), Madrid, Spain.
- 20 Pulmonary Vascular Disease Unit, Royal Papworth Hospital, Cambridge, UK.
- 21 VU Medisch Centrum, Amsterdam, the Netherlands.
- 22 Department III of Internal Medicine and Cologne Cardiovascular Research Center (CCRC), Cologne University Heart Center, Cologne, Germany.
- 23 Clinic of Pulmonology, University Hospital Zurich, Zurich, Switzerland.
- 24 Servicestelle für klinische Studien, Krankenhaus der Elisabethinen Linz GmbH, Linz, Austria.
- 25 Department of Respiratory Diseases, University Hospitals of Leuven, and Respiratory Division, Department CHROMETA, KU Leuven - University of Leuven, Leuven, Belgium.
- 26 2(nd) Department of Medicine, Department of Cardiovascular Medicine, Charles University in Prague, Prague, Czech Republic.
- 27 Department of Cardiology and Angiology, Faculty of Medicine, Slovak Medical University & National Institute of Cardiovascular Diseases, Bratislava, Slovak Republic.
- 28 Department of Cardiology I, Aristotle University of Thessaloniki, Thessaloniki, Greece.
- 29 German Rheumatism Research Center Berlin, Leibniz Institute, Berlin, Germany.
- 30 Bayer AG, Global Development, Global Medical Affairs, Berlin, Germany.
- 31 Department of Respiratory Medicine and the German Center for Lung Research, Hannover Medical School, Hannover, Germany.
- 32 Pneumonology Service, Hospital Universitario Fundación Favaloro, Buenos Aires, Argentina.
- 33 Clinical Cardiology Service, ICBA - Instituto Cardiovascular de Buenos Aires, Buenos Aires, Argentina.
- 34 Department of Cardiology, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
- 35 Center for Respiratory Medicine, Hospital Británico, Buenos Aires, Argentina.
- 36 Pneumonology, Cen Asma Centro de Enfermedades Respiratorias, Buenos Aires, Argentina.
- 37 Pneumonology, Instituto Diagnostico, Buenos Aires, Argentina.
- 38 Heart Lung Clinic, St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia.
- 39 Queensland Lung Transplant Service (QLTS), Prince Charles Hospital, Chermside, QLD, Australia.
- 40 Department of Cardiology, Royal Hobart Hospital, Hobart, Tasmania, Australia.
- 41 Rheumatology Department, St Vincent's Hospital, Melbourne, Victoria, Australia.
- 42 Clinical Trials Centre, Cardiology Service, Royal Adelaide Hospital, Adelaide, South Australia, Australia.
- 43 Flinders Cardiac Clinic, Flinders Medical Centre, Bedford Park, South Australia, Australia.
- 44 Immunology Department, John Hunter Hospital, Newcastle, New South Wales, Australia.
- 45 Advanced Lung Disease Unit, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.
- 46 Nepean Hospital, Kingswood, New South Wales, Australia.
- 47 Clinical Department of Cardiology, Medical University of Vienna, Vienna, Austria.
- 48 Department of Internal Medicine II, Medical University of Innsbruck, Innsbruck, Austria.
- 49 Department of Intensive Care, Centre Hospitalier Université Dinant-Mont-Godinne, Yvoir, Belgium.
- 50 Department of Pulmonary Medicine, Centre Hospitalier Université Liège, Liège, Belgium.
- 51 Department of Internal Medicine and Pediatrics, Ghent University Hospital, Ghent, Belgium.
- 52 Centre for Critical Illness Research, Lawson Health Research Institute, London, Ontario, Canada.
- 53 Internal Medicine and Pneumonology, Fundación Neumológica, Bogotá, Colombia.
- 54 Pneumonology Department, Clínica Cardio, VID, Medellin, Colombia.
- 55 Pneumonology Service, Fundación Cardiovascular de Colombia, Floridablanca, Santander, Colombia.
- 56 Valle de Lili Foundation, Cali, Colombia.
- 57 Department of Clinical Medicine, Aarhus University Hospital Skejby, Aarhus, Denmark.
- 58 Centre of Cardiology, North Estonia Medical Centre Foundation, Tallinn, Estonia.
- 59 Department of Pulmonology, Tartu University Hospital, Tartu, Estonia.
- 60 Heart Center, Sydänkeskus Turku University Hospital, Turku, Finland.
- 61 Hôpital Bicêtre, Le Kremlin-Bicêtre, France.
- 62 National Reference Centre for Rare Pulmonary Diseases, Hôpital Louis Pradel, Lyon, France.
- 63 Pneumonology Service, Hôpital Larrey, Toulouse, France.
- 64 Department of Pneumology, University Hospital Carl Gustav Carus, Dresden, Germany.
- 65 Centre for Pulmonary Hypertension, Thoraxklinik at Heidelberg University Hospital, Heidelberg, Germany.
- 66 Department of Internal Medicine, Clinic and Polyclinic for Internal Medicine B, Greifswald, Germany.
- 67 Center for Thrombosis and Hemostasis, University Medical Center of the Johannes Gutenberg University, Mainz, Germany.
- 68 Respiratory Insufficiency Unit, "G. Papanikolaou" General Hospital of Thessaloniki, Thessaloniki, Greece.
- 69 Department of Intensive Care Medicine, University Hospital of Heraklion, Heraklion, Greece.
- 70 2nd Department of Cardiology, University Hospital of Ioannina, Ioannina, Greece.
- 71 Division of Cardiology, University Hospital of Ioannina, Ioannina, Greece.
- 72 National Pulmonary Hypertension Unit, Mater Misericordiae University Hospital, Dublin, Ireland.
- 73 Policlinico Umberto I, Department of Cardiovascular, Respiratory, Nephrological, Anaesthesiological, and Geriatric Sciences, La Sapienza Hospital, Rome, Italy.
- 74 Monzino Cardiology Center Hospital, Milan, Italy.
- 75 Department of Cardiology, Monaldi Hospital, Naples, Italy.
- 76 Pneumology Unit, Careggi University Hospital, Florence, Italy.
- 77 Pneumology Clinic, Cardiothoracic and Vascular Department, San Gerardo Hospital, Monza, Italy.
- 78 Cardiothoracic and Vascular Department, Policlinico San Matteo, Pavia, Italy.
- 79 Institute of Clinical Physiology, Toscana Gabriele Monasterio Foundation, CNR Research Area, Pisa, Italy.
- 80 Department of Medicine, Integrated University Hospital Verona, Verona, Italy.
- 81 Department of Cardiology, Policlinico Vittorio Emanuele, Catania, Italy.
- 82 Division of Cardiology, Miulli General Hospital, Fonti-Bari, Italy.
- 83 Department of Cardiology, Hospital Santa Maria della Misericordia, Rovigo, Italy.
- 84 Pneumology Service, Centre Hospitalier de Luxembourg, Luxembourg.
- 85 Department of Pulmonary Diseases, Erasmus Medical Centre, Rotterdam, the Netherlands.
- 86 Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.
- 87 Department of Cardiology, Coimbra Hospital and University Center, Coimbra, Portugal.
- 88 Department of Pneumology, Hospital Center Vila Nova de Gaia/Espinho, Vila Nova de Gaia, Portugal.
- 89 Cardiology Department, Hospital Garcia de Orta, E.P.E., Almada, Portugal.
- 90 Department of Medicine I, North Lisbon Hospital Center, Lisbon, Portugal.
- 91 State Budgetary Institution of the Republic of Sakha (Yakutia) "Republican Hospital №1 - National Center for Medicine", Yakutsk, Russia.
- 92 State Educational Institution of Higher Professional Education "Orenburg State Medical University", Orenburg, Russia.
- 93 State Budgetary Healthcare Institution "Primorskaya Regional Clinical Hospital №1", Vladivostok, Russia.
- 94 Federal State Budgetary Scientific Institution "Research Institute for Complex Problems of Cardiovascular Diseases", Kemerovo, Russia.
- 95 Federal State Budgetary Institution "Scientific Research Institute of Pulmonology of the Federal Bio-Medical Agency", Moscow, Russia.
- 96 State Budgetary Institution of High Professional Education "Kazan State Medical University", Kazan, Russia.
- 97 State Budgetary Healthcare Institution "Sverdlovsk Regional Clinical Hospital No.1", Yekaterinburg, Russia.
- 98 State Budget Institution of the Ryazan Region "Regional Clinical Cardiology Dispensary", Ryazan, Russia.
- 99 Chelyabinsk Regional Cardiology Clinic, Chelyabinsk, Russia.
- 100 Perm Regional State Budgetary Healthcare Institution "Clinical Cardiologic Dispensary", Perm, Russia.
- 101 State Autonomous Healthcare Institution Amur Region "Amur Regional Clinical Hospital", Blagoveschensk, Russia.
- 102 Federal State Budget Institution "Russian Cardiology Research and Production Complex" of the Russian Federation, Moscow, Russia.
- 103 Regional State Budgetary Healthcare Institution "Regional Clinical Hospital №1", Khabarovsk, Russia.
- 104 State Budgetary Healthcare Institution "Volgograd Regional Clinical Cardiology Center", Volgograd, Russia.
- 105 State Budgetary Healthcare Institution "Regional Clinical Hospital", Tver, Russia.
- 106 State Healthcare Institution "City Hospital No.13 in Tula", Tula, Russia.
- 107 Pulmonary Medicine Section, Department of Medicine, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia.
- 108 Pulmonary Medicine, King Fahad Medical City, Riyadh, Saudi Arabia.
- 109 Department of Cardiology, Hospital 12 de Octubre, Madrid, Spain.
- 110 Hospital Clínic-IDIBAPS, University of Barcelona, Barcelona, Spain.
- 111 Department of Medicine, Hospital Vall Hebron, Barcelona, Spain.
- 112 Medical-Surgical Unit of Respiratory Diseases, University Hospital Virgen Del Rocio, Seville, Spain.
- 113 Department of Internal Medicine, Hospital De Jerez, Jerez De La Frontera, Spain.
- 114 Pneumology Department, Hospital La Fe, Valencia, Spain.
- 115 Department of Cardiology, Hospital Gregorio Marañon, Madrid, Spain.
- 116 Pneumology Service, Hospital Dr Negrin, Las Palmas, Spain.
- 117 Servicio de Anestesiología y Reanimación, Hospital Marques de Valdecilla, Santander, Spain.
- 118 Heart Center, Norrland University Hospital, Umeå, Sweden.
- 119 Department of Cardiology, Sahlgrenska University Hospital, Göteborg, Sweden.
- 120 Department of Cardiology, Linköping University Hospital, Linköping, Sweden.
- 121 Pulmonary Division, Geneva University Hospitals, Geneva, Switzerland.
- 122 Department of Internal Medicine, National Cheng Kung University Hospital, Tainan City, Taiwan.
- 123 Department of Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan.
- 124 Cardiovascular Center, Mackay Memorial Hospital, Taipei City, Taiwan.
- 125 Division of Cardiology, Heart Center, Cheng Hsin General Hospital, Taipei City, Taiwan.
- 126 Department of Internal Medicine, National Taiwan University Hospital, Taipei City, Taiwan.
- 127 Department of Medicine, Taipei Veterans General Hospital, Taipei City, Taiwan.
- 128 Department of Cardiology, Kaohsiung Veterans General Hospital, Kaohsiung City, Taiwan.
- 129 Department of Internal Medicine, Chang Gung Memorial Hospital, Linkou, Taoyuan County, Taiwan.
- 130 Department of Cardiology, Marmara University Faculty of Medicine, Istanbul, Turkey.
- 131 Department of Chest Diseases, Istanbul University Cerrahpasa Faculty of Medicine, Istanbul, Turkey.
- 132 Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey.
- 133 Department of Respiratory Medicine, Cukurova University, Adana, Turkey.
- 134 Department of Respiratory Medicine, Freeman Hospital, Newcastle, United Kingdom.
- 135 Scottish Pulmonary Vascular Unit, Golden Jubilee National Hospital, Clydebank, West Dunbartonshire, United Kingdom.
- 136 Pulmonary Vascular Disease Unit, Royal Papworth Hospital, Cambridge, United Kingdom.
- PMID: 33540340
- DOI: 10.1016/j.rmed.2020.106220
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Abstract
Objective: The soluble guanylate cyclase stimulator riociguat is approved for the treatment of adult patients with pulmonary arterial hypertension (PAH) and inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) following Phase 3 randomized trials. The EXPosurE Registry RiociguaT in patients with pulmonary hypertension (EXPERT) study was designed to monitor the long-term safety of riociguat in clinical practice.
Methods: EXPERT was an international, multicenter, prospective, uncontrolled, non-interventional cohort study of patients treated with riociguat. Patients were followed for at least 1 year and up to 4 years from enrollment or until 30 days after stopping riociguat treatment. Primary safety outcomes were adverse events (AEs) and serious adverse events (SAEs) coded using Medical Dictionary for Regulatory Activities preferred terms and System Organ Classes version 21.0, collected during routine clinic visits and collated via case report forms.
Results: In total, 956 patients with CTEPH were included in the analysis. The most common AEs in these patients were peripheral edema/edema (11.7%), dizziness (7.5%), right ventricular (RV)/cardiac failure (7.7%), and pneumonia (5.0%). The most common SAEs were RV/cardiac failure (7.4%), pneumonia (4.1%), dyspnea (3.6%), and syncope (2.5%). Exposure-adjusted rates of hemoptysis/pulmonary hemorrhage and hypotension were low and comparable to those in the long-term extension study of riociguat (Chronic Thromboembolic Pulmonary Hypertension Soluble Guanylate Cyclase-Stimulator Trial [CHEST-2]).
Conclusion: Data from EXPERT show that in patients with CTEPH, the safety of riociguat in routine practice was consistent with the known safety profile of the drug, and no new safety concerns were identified.
Keywords: Chronic thromboembolic pulmonary hypertension; Clinical practice; Real-world; Registry; Riociguat; Safety.
Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.
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