Riociguat treatment in patients with pulmonary arterial hypertension: Final safety data from the EXPERT registry - 23/02/21

Doi : 10.1016/j.rmed.2020.106241

Marius M. Hoeper ^a,^⁎ , Miguel-Angel Gomez Sanchez ^b, Marc Humbert ^c, David Pittrow ^d, Gérald Simonneau ^e, Henning Gall ^f, Ekkehard Grünig ^g, Hans Klose ^h, Michael Halank ⁱ, David Langleben ^j, Repke J. Snijder ^k, Pilar Escribano Subias ^l, Lisa M. Mielniczuk ^m, Tobias J. Lange ⁿ, Jean-Luc Vachiéry ^o, Hubert Wirtz ^p, Douglas S. Helmersen ^q, Iraklis Tsangaris ^r, Joan A. Barberà ^s,^t, Joanna Pepke-Zaba ^u, Anco Boonstra ^v, Stephan Rosenkranz ^w, Silvia Ulrich ^x, Regina Steringer-Mascherbauer ^y, Marion Delcroix ^z, Pavel Jansa ^aa, Iveta Šimková ^bb, George Giannakoulas ^cc, Jens Klotsche ^dd, Evgenia Williams ^ee, Christian Meier ^ee, Hossein-Ardeschir Ghofrani ^f
Collaborators list
Jorge Caneva ^ai, Graciela Tuhay ^ai, Mirta Diez ^aj, Maria Lujan Talavera ^aj, Adriana Acosta ^aj, Norberto Vulcano ^ak, Martin Bosio ^al, Lorena Maldonado ^al, Sabino Deleo ^am, Luciano Melatini ^an, Anne Keogh ^ao, Eugene Kotlyar ^ao, John Feenstra ^ap, Nathan Dwyer ^aq, Heath Adams ^aq, Wendy Stevens ^ar, Peter Steele ^as, Susanna Proudman ^as, Robert Minson ^at, Glenn Reeves ^au, Melanie Lavender ^av, Benjamin Ng ^aw, Michele Mackenzie ^aw, Lisa Barry ^aw, Margarethe Gruenberger ^ax, Charlotte Huber ^ax, Irene Lang ^ay, Ioana Tilea ^ay, Roela Sadushi-Kolici ^ay, Judith Löffler-Ragg ^az, Lisa-Theresa Feistmantl ^az, Patrick Evrard ^ba, Julien Guiot ^bb, Marco Naldi ^bb, Michel De Pauw ^bc, Renaud Louis ^bb, Sanjay Mehta ^bd, Rafael Conde Camacho ^be, Patricia Parada Tovar ^be, Alejandro Londoño ^bf, Felipe Campo ^bf, Paula Garcia ^bf, Camila Lema ^bf, Mauricio Orozco-Levi ^bg, William Martinez ^bh, Juan Esteban Gomez ^bh, Jens Erik Nielsen-Kudsk ^bi, Soren Mellemkjaer ^bi, Ly Anton ^bj, Alan Altraja ^bk, Tapani Vihinen ^bl, Tuija Vasankari ^bl, Olivier Sitbon ^bm, Vincent Cottin ^bn, Laurent Têtu ^bo, Elise Noël-Savina ^bo, Nicole Shearman ^bp, Susanne Tayler ^bp, Ilona Olzik ^bp, Christine Kulka ^bq, Jan Grimminger ^br, Marcel Simon ^br, Anna Nolde ^br, Tim Oqueka ^br, Lars Harbaum ^br, Benjamin Egenlauf ^bs, Ralf Ewert ^bt, Christian Schulz ^bu, Sabine Regotta ^bu, Tilmann Kramer ^bv, Susanne Knoop-Busch ^bv, Felix Gerhardt ^bv, Stavros Konstantinides ^bw, Georgia Pitsiou ^bx, Ioannis Stanopoulos ^bx, Evdokia Sourla ^bx, Sofia Mouratoglou ^by, Haralambos Karvounis ^by, Athanasios Pappas ^bz, Ioanna Mitrouska ^ca, Dimitrios Georgopoulos ^ca, Michail Fanaridis ^ca, Lampros Michalis ^cb, Konstantinos Pappas ^cc, Anna Kotsia ^cc, Sean Gaine ^cd, Carmine Dario Vizza ^ce, Giovanna Manzi ^ce, Roberto Poscia ^ce, Roberto Badagliacca ^ce, Piergiuseppe Agostoni ^cf, Noemi Bruno ^cf, Stefania Farina ^cf, Michele D'Alto ^cg, Paola Argiento ^cg, Anna Correra ^cg, Giovanni Maria Di Marco ^cg, Chiara Cresci ^ch, Vieri Vannucchi ^ch, Elena Torricelli ^ch, Alessio Garcea ^ch, Alberto Pesci ^ci, Luca Sardella ^ci, Giuseppe Paciocco ^ci, Federico Pane ^ci, Andrea Maria D'Armini ^cj, Maurizio Pin ^cj, Valentina Grazioli ^cj, Giulia Massola ^cj, Antonio Sciortino ^cj, Renato Prediletto ^ck, Carolina Bauleo ^ck, Edoardo Airò ^ck, Rudina Ndreu ^ck, Ivana Pavlickova ^ck, Claudio Lunardi ^cl, Silvia Farruggio ^cm, Serena Costa ^cm, Massimiliano Mulè ^cm, Giuseppe Galgano ^cn, Mario Petruzzi ^cn, Anna De Luca ^cn, Francesco Lombardi ^cn, Loris Roncon ^co, Luca Conte ^co, Claudio Picariello ^co, Gil Wirtz ^cp, Myriam Alexandre ^cp, A. Vonk-Noordegraaf ^cq, H. Boogaard ^cq, J. Mager ^cr, H. Reesink ^cr, Leon M. van den Toorn ^cs, Karin Boomars ^cs, Arne K. Andreassen ^ct, Graça Castro ^cu, Gonçalves Tania ^cu, Rui Baptista ^cu, António Marinho ^cu, Teresa Shiang ^cv, Ana Oliveira ^cv, Daniel Coutinho ^cv, Joana Sousa ^cv, Maria José Loureiro ^cw, Débora Repolho ^cw, Susana Maria Martins Jesus ^cx, Marta Capinha ^cx, João Agostinho ^cx, Tania Cardoso ^cx, Andreia Rocha ^cx, Mafalda Espinha ^cx, Kyundyul Ivanovich Ivanov ^cy, Dalyana Eduardovna Alexeeva ^cy, Marina Vadimovna Batalina ^cz, Daria Viktorovna Hegya ^da, Tatyana Nikolaevna Zvereva ^db, Sergey Nikolaevich Avdeev ^dc, Natalia Anatolievna Tsareva ^dc, Albert Sarvatovich Galyavich ^dd, Bykov Aleksander Nikolaevich ^de, Evgeny Vladimirovich Filippov ^df, Olga Eduardovna Yakovleva ^dg, Olga Borisovna Pavlova ^dh, Elena Sergeevna Skripkina ^di, Tamila Vitalievna Martynyuk ^dj, Irina Fedorovna Bukatova ^dk, Anna Viktorovna Tregubova ^dl, Dmitry Yurievich Platonov ^dm, Tatyana Mikhaylovna Kolomeytseva ^dn, Abdullah Al Dalaan ^do, Abeer Abeer Abdelsayed ^do, Ihab Weheba ^do, Sarferaz Saleemi ^do, Hussam Sakkijha ^dp, Marcela Bohacekova ^dq, Tatiana Valkovicova ^dq, Iveta Farkasova ^dq, Carlos Andres Quezada ^dr, Lucilla Piccari ^ds, Isabel Blanco ^ds, Laura Sebastian ^ds, Antonio Roman ^dt, Manuel Lopez ^dt, Remedios Otero ^du, Teresa Elias ^du, Luis Jara ^du, Isabel Asencio ^du, Josefa Jiménez Arjona ^dv, Raúl Menor Almagro ^dv, Salvador López Cárdenas ^dv, Salvador Alcaraz García ^dv, Patricia Villanueva Rodríguez ^dv, Raquel Lopez ^dw, Alberto Garcia ^dw, Francisco Fernandez Avilés ^dx, Sebastian De La Pava ^dx, Raquel Yotti ^dx, Gregorio Pérez Peñate ^dy, Fernando León Marrero ^dy, José Manuel Cifrián Martínez ^dz, Amaya Martinez-Meñaca ^dz, Lecue Pilar Alonso ^dz, Sonia Fernandez Rozas ^dz, David Iturbe Fernandez ^dz, Victor Mora Cuesta ^dz, Stefan Söderberg ^ea, Sven-Erik Bartfay ^eb, Bengt Rundqvist ^eb, Monthir Alfetlawi ^ec, Peter Wodlin ^ec, Esther Irene Schwarz ^ed, Rudolf Speich ^ed, Frédéric Lador ^ee, Thierry Rochat ^ee, Paola Gasche-Soccal ^ee, Chih-Hsin Hsu ^ef, Tsung-Hsien Lin ^eg, Ho-Ming Su ^eg, Wen-Ter Lai ^eg, Chun Yuan Chu ^eg, Po-Chao Hsu ^eg, Wen-Chol Voon ^eg, Hsueh-Wei Yen ^eg, Jacob Yih-Jer Wu ^eh, Shu-Hao Wu ^eh, Wen-Pin Huang ^ei, Man-Cai Fong ^ei, Chien-Lung Huang ^ei, Ping-Hung Kuo ^ej, Yen-Hung Lin ^ej, Jiunn-Lee Lin ^ej, Chi-Sheng Hung ^ej, Cho-Kai Wu ^ej, Shih-Hsien Sung ^ek, Wei-Chun Huang ^el, Chin-Chang Cheng ^el, Shu-Hung Kuo ^el, Wen-Hwa Wang ^el, Wan-Jing Ho ^em, Tsu-Shiu Hsu ^em, Bülent Mutlu ^en, Halil Atas ^en, Gul Ongen ^eo, Zeynep Un ^eo, Gulfer Okumus ^ep, Ismail Hanta ^eq, Paul Corris ^er, Andrew Peacock ^es, Colin Church ^es, Mark Toshner ^et, Michael Newnham ^et
^ai Pneumonology Service, Hospital Universitario Fundación Favaloro, Buenos Aires, Argentina
^aj Clinical Cardiology Service, ICBA - Instituto Cardiovascular de Buenos Aires, Buenos Aires, Argentina
^ak Department of Cardiology, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina
^al Center for Respiratory Medicine, Hospital Británico, Buenos Aires, Argentina
^am Pneumonology, Cen Asma Centro de Enfermedades Respiratorias, Buenos Aires, Argentina
^an Pneumonology, Instituto Diagnostico, Buenos Aires, Argentina
^ao Heart Lung Clinic, St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia
^ap Queensland Lung Transplant Service (QLTS), Prince Charles Hospital, Chermside, QLD, Australia
^aq Department of Cardiology, Royal Hobart Hospital, Hobart, Tasmania, Australia
^ar Rheumatology Department, St Vincent's Hospital, Melbourne, Victoria, Australia
^as Clinical Trials Centre, Cardiology Service, Royal Adelaide Hospital, Adelaide, South Australia, Australia
^at Flinders Cardiac Clinic, Flinders Medical Centre, Bedford Park, South Australia, Australia
^au Immunology Department, John Hunter Hospital, Newcastle, New South Wales, Australia
^av Advanced Lung Disease Unit, Fiona Stanley Hospital, Murdoch, Western Australia, Australia
^aw Nepean Hospital, Kingswood, New South Wales, Australia
^ax Servicestelle für klinische Studien, Krankenhaus der Elisabethinen Linz GmbH, Linz, Austria
^ay Clinical Department of Cardiology, Medical University of Vienna, Vienna, Austria
^az Department of Internal Medicine II, Medical University of Innsbruck, Innsbruck, Austria
^ba Department of Intensive Care, Centre Hospitalier Université Dinant-Mont-Godinne, Yvoir, Belgium
^bb Department of Pulmonary Medicine, Centre Hospitalier Université Liège, Liège, Belgium
^bc Department of Internal Medicine and Pediatrics, Ghent University Hospital, Ghent, Belgium
^bd Centre for Critical Illness Research, Lawson Health Research Institute, London, Ontario, Canada
^be Internal Medicine and Pneumonology, Fundación Neumológica, Bogotá, Colombia
^bf Pneumonology Department, Clínica Cardio VID, Medellin, Colombia
^bg Pneumonology Service, Fundación Cardiovascular de Colombia, Floridablanca, Santander, Colombia
^bh Valle de Lili Foundation, Cali, Colombia
^bi Department of Clinical Medicine, Aarhus University Hospital Skejby, Aarhus, Denmark
^bj Centre of Cardiology, North Estonia Medical Centre Foundation, Tallinn, Estonia
^bk Department of Pulmonology, Tartu University Hospital, Tartu, Estonia
^bl Heart Center, Sydänkeskus Turku University Hospital, Turku, Finland
^bm Hôpital Bicêtre, Le Kremlin-Bicêtre, France
^bn National Reference Centre for Rare Pulmonary Diseases, Hôpital Louis Pradel, Lyon, France
^bo Pneumonology Service, Hôpital Larrey, Toulouse, France
^bp Department of Respiratory Medicine and the German Center for Lung Research, Hannover Medical School, Hannover, Germany
^bq Department of Pneumology, University Hospital Carl Gustav Carus, Dresden, Germany
^br Department of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
^bs Centre for Pulmonary Hypertension, Thoraxklinik at Heidelberg University Hospital, Heidelberg, Germany
^bt Department of Internal Medicine, Clinic and Polyclinic for Internal Medicine B, Greifswald, Germany
^bu Department of Internal Medicine II, Division of Pneumology, University Medical Center, Regensburg, Germany
^bv Department III of Internal Medicine and Cologne Cardiovascular Research Center (CCRC), Cologne University Heart Center, Cologne, Germany
^bw Center for Thrombosis and Hemostasis, University Medical Center of the Johannes Gutenberg University, Mainz, Germany
^bx Respiratory Insufficiency Unit, “G. Papanikolaou” General Hospital of Thessaloniki, Thessaloniki, Greece
^by Department of Cardiology I, Aristotle University of Thessaloniki, Thessaloniki, Greece
^bz Second Department of Critical Care, University Hospital Attikon, National and Kapodistrian University of Athens, Athens, Greece
^ca Department of Intensive Care Medicine, University Hospital of Heraklion, Heraklion, Greece
^cb 2nd Department of Cardiology, University Hospital of Ioannina, Ioannina, Greece
^cc Division of Cardiology, University Hospital of Ioannina, Ioannina, Greece
^cd National Pulmonary Hypertension Unit, Mater Misericordiae University Hospital, Dublin, Ireland
^ce Policlinico Umberto I, Department of Cardiovascular, Respiratory, Nephrological, Anaesthesiological, and Geriatric Sciences, La Sapienza Hospital, Rome, Italy
^cf Monzino Cardiology Center Hospital, Milan, Italy
^cg Department of Cardiology, Monaldi Hospital, Naples, Italy
^ch Pneumology Unit, Careggi University Hospital, Florence, Italy
^ci Pneumology Clinic, Cardiothoracic and Vascular Department, San Gerardo Hospital, Monza, Italy
^cj Cardiothoracic and Vascular Department, Policlinico San Matteo, Pavia, Italy
^ck Institute of Clinical Physiology, Toscana Gabriele Monasterio Foundation, CNR Research Area, Pisa, Italy
^cl Department of Medicine, Integrated University Hospital Verona, Verona, Italy
^cm Department of Cardiology, Policlinico Vittorio Emanuele, Catania, Italy
^cn Division of Cardiology, Miulli General Hospital, Fonti-Bari, Italy
^co Department of Cardiology, Hospital Santa Maria della Misericordia, Rovigo, Italy
^cp Pneumology Service, Centre Hospitalier de Luxembourg, Luxembourg
^cq VU Medisch Centrum, Amsterdam, the Netherlands
^cr Department of Pulmonology, St Antonius Ziekenhuis, Nieuwegein, the Netherlands
^cs Department of Pulmonary Diseases, Erasmus Medical Centre, Rotterdam, the Netherlands
^ct Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway
^cu Department of Cardiology, Coimbra Hospital and University Center, Coimbra, Portugal
^cv Department of Pneumology, Hospital Center Vila Nova de Gaia/Espinho, Vila Nova de Gaia, Portugal
^cw Cardiology Department, Hospital Garcia de Orta, E.P.E., Almada, Portugal
^cx Department of Medicine I, North Lisbon Hospital Center, Lisbon, Portugal
^cy State Budgetary Institution of the Republic of Sakha (Yakutia) “Republican Hospital №1 - National Center for Medicine”, Yakutsk, Russia
^cz State Educational Institution of Higher Professional Education “Orenburg State Medical University”, Orenburg, Russia
^da State Budgetary Healthcare Institution “Primorskaya Regional Clinical Hospital №1", Vladivostok, Russia
^db Federal State Budgetary Scientific Institution “Research Institute for Complex Problems of Cardiovascular Diseases”, Kemerovo, Russia
^dc Federal State Budgetary Institution “Scientific Research Institute of Pulmonology of the Federal Bio-Medical Agency”, Moscow, Russia
^dd State Budgetary Institution of High Professional Education “Kazan State Medical University”, Kazan, Russia
^de State Budgetary Healthcare Institution “Sverdlovsk Regional Clinical Hospital No.1", Yekaterinburg, Russia
^df State Budget Institution of the Ryazan Region “Regional Clinical Cardiology Dispensary”, Ryazan, Russia
^dg Chelyabinsk Regional Cardiology Clinic, Chelyabinsk, Russia
^dh Perm Regional State Budgetary Healthcare Institution “Clinical Cardiologic Dispensary”, Perm, Russia
^di State Autonomous Healthcare Institution Amur Region “Amur Regional Clinical Hospital”, Blagoveschensk, Russia
^dj Federal State Budget Institution “Russian Cardiology Research and Production Complex” of the Russian Federation, Moscow, Russia
^dk Regional State Budgetary Healthcare Institution “Regional Clinical Hospital №1", Khabarovsk, Russia
^dl State Budgetary Healthcare Institution “Volgograd Regional Clinical Cardiology Center”, Volgograd, Russia
^dm State Budgetary Healthcare Institution “Regional Clinical Hospital”, Tver, Russia
^dn State Healthcare Institution “City Hospital No.13 in Tula”, Tula, Russia
^do Pulmonary Medicine Section, Department of Medicine, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia
^dp Pulmonary Medicine, King Fahad Medical City, Riyadh, Saudi Arabia
^dq Department of Cardiology and Angiology, Faculty of Medicine, Slovak Medical University & National Institute of Cardiovascular Diseases, Bratislava, Slovak Republic
^dr Department of Cardiology, Hospital 12 de Octubre, Madrid, Spain
^ds Hospital Clínic-IDIBAPS, University of Barcelona, Barcelona, Spain
^dt Department of Medicine, Hospital Vall Hebron, Barcelona, Spain
^du Medical-Surgical Unit of Respiratory Diseases, University Hospital Virgen Del Rocio, Seville, Spain
^dv Department of Internal Medicine, Hospital De Jerez, Jerez De La Frontera, Spain
^dw Pneumology Department, Hospital La Fe, Valencia, Spain
^dx Department of Cardiology, Hospital Gregorio Marañon, Madrid, Spain
^dy Pneumology Service, Hospital Dr Negrin, Las Palmas, Spain
^dz Servicio de Anestesiología y Reanimación, Hospital Marques de Valdecilla, Santander, Spain
^ea Heart Center, Norrland University Hospital, Umeå, Sweden
^eb Department of Cardiology, Sahlgrenska University Hospital, Göteborg, Sweden
^ec Department of Cardiology, Linköping University Hospital, Linköping, Sweden
^ed Clinic of Pulmonology, University Hospital Zurich, Zurich, Switzerland
^ee Pulmonary Division, Geneva University Hospitals, Geneva, Switzerland
^ef Department of Internal Medicine, National Cheng Kung University Hospital, Tainan City, Taiwan
^eg Department of Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan
^eh Cardiovascular Center, Mackay Memorial Hospital, Taipei City, Taiwan
^ei Division of Cardiology, Heart Center, Cheng Hsin General Hospital, Taipei City, Taiwan
^ej Department of Internal Medicine, National Taiwan University Hospital, Taipei City, Taiwan
^ek Department of Medicine, Taipei Veterans General Hospital, Taipei City, Taiwan
^el Department of Cardiology, Kaohsiung Veterans General Hospital, Kaohsiung City, Taiwan
^em Department of Internal Medicine, Chang Gung Memorial Hospital, Linkou, Taoyuan County, Taiwan
^en Department of Cardiology, Marmara University Faculty of Medicine, Istanbul, Turkey
^eo Department of Chest Diseases, Istanbul University Cerrahpasa Faculty of Medicine, Istanbul, Turkey
^ep Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey
^eq Department of Respiratory Medicine, Cukurova University, Adana, Turkey
^er Department of Respiratory Medicine, Freeman Hospital, Newcastle, United Kingdom
^es Scottish Pulmonary Vascular Unit, Golden Jubilee National Hospital, Clydebank, West Dunbartonshire, United Kingdom
^et Pulmonary Vascular Disease Unit, Royal Papworth Hospital, Cambridge, United Kingdom

^a Department of Respiratory Medicine and the German Center for Lung Research, Hannover Medical School, Hannover, Germany
^b Respiratory Department, Ramón y Cajal University Hospital (IRYCIS), Biomedical Research Networking Center on Respiratory Diseases (CIBERES), Madrid, Spain
^c Université Paris-Saclay, Inserm U999, Service de Pneumologie et Soins Intensifs Respiratoires, Hôpital Bicêtre, Le Kremlin-Bicêtre, France
^d Institute for Clinical Pharmacology, Technical University, Dresden, Germany
^e 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
^f University of Giessen and Marburg Lung Center (UGMLC), Giessen, Germany; Member of the German Center for Lung Research (DZL), Germany
^g Centre for Pulmonary Hypertension, Thoraxclinic at Heidelberg University Hospital, Heidelberg, Germany
^h Department of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
ⁱ Medical Clinic I, Department of Pneumology, University Hospital Carl Gustav Carus, Dresden, Germany
^j Center for Pulmonary Vascular Disease, Jewish General Hospital, McGill University, Montreal, Quebec, Canada
^k Department of Pulmonology, St Antonius Ziekenhuis, Nieuwegein, the Netherlands
^l Department of Cardiology, Hospital 12 de Octubre, CIBER-CV (CIBER of Cardiovascular Disease), Madrid, Spain
^m Division of Cardiology, Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada
ⁿ Department of Internal Medicine II, Division of Pneumology, University Medical Center, Regensburg, Germany
^o Département de Cardiologie, Cliniques Universitaires de Bruxelles, Hôpital Erasme, Brussels, Belgium
^p Department of Respiratory Medicine, University of Leipzig, Leipzig, Germany
^q Alberta Health Services, University of Calgary, Calgary, Alberta, Canada
^r Second Department of Critical Care, University Hospital Attikon, National and Kapodistrian University of Athens, Athens, Greece
^s Hospital Clínic-IDIBAPS, University of Barcelona, Barcelona, Spain
^t Biomedical Research Networking Center on Respiratory Diseases (CIBERES), Madrid, Spain
^u Pulmonary Vascular Disease Unit, Royal Papworth Hospital, Cambridge, UK
^v VU Medisch Centrum, Amsterdam, the Netherlands
^w Department III of Internal Medicine and Cologne Cardiovascular Research Center (CCRC), Cologne University Heart Center, Cologne, Germany
^x Clinic of Pulmonology, University Hospital Zurich, Zurich, Switzerland
^y Servicestelle für Klinische Studien, Krankenhaus der Elisabethinen Linz GmbH, Linz, Austria
^z Clinical Department of Respiratory Diseases, University Hospitals and Laboratory of Respiratory Diseases & Thoracic Surgery (BREATHE), Department of Chronic Diseases & Metabolism (CHROMETA), KU Leuven – University of Leuven, Leuven, Belgium
^aa 2^nd Department of Medicine–Department of Cardiovascular Medicine, Charles University in Prague, Prague, Czech Republic
^bb Department of Cardiology and Angiology, Faculty of Medicine, Slovak Medical University & National Institute of Cardiovascular Diseases, Bratislava, Slovak Republic
^cc Department of Cardiology I, Aristotle University of Thessaloniki, Thessaloniki, Greece
^dd German Rheumatism Research Center Berlin, Leibniz Institute, Berlin, Germany
^ee Bayer AG, Global Development, Global Medical Affairs, Berlin, Germany

^∗Corresponding author. Department of Respiratory Medicine and the German Center for Lung Research, Hannover Medical School, Hannover, Germany.Department of Respiratory Medicine and the German Center for Lung ResearchHannover Medical SchoolHannoverGermany

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 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 (usually every 3–6 months) and collated via case report forms.

Results

In total, 326 patients with PAH were included in the analysis. The most common AEs in these patients were dizziness (11.7%), right ventricular (RV)/cardiac failure (10.7%), edema/peripheral edema (10.7%), diarrhea (8.6%), dyspnea (8.0%), and cough (7.7%). The most common SAEs were RV/cardiac failure (10.1%), pneumonia (6.1%), dyspnea (4.0%), and syncope (3.4%). The exposure-adjusted rate of hemoptysis/pulmonary hemorrhage was 2.5 events per 100 patient-years.

Conclusion

Final data from EXPERT show that in patients with PAH, the safety of riociguat in clinical practice was consistent with clinical trials, with no new safety concerns identified and a lower exposure-adjusted rate of hemoptysis/pulmonary hemorrhage than in the long-term extension of the Phase 3 trial in PAH.

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Highlights

•	Riociguat is approved for the treatment of pulmonary arterial hypertension (PAH).
•	The EXPERT study evaluated the safety of riociguat in clinical practice.
•	Results are available for 326 PAH patients in 28 countries, followed for 1–4 years.
•	The safety of riociguat in clinical practice was consistent with clinical trials.
•	No new safety concerns were identified.

Le texte complet de cet article est disponible en PDF.

Keywords : Pulmonary arterial hypertension, Pulmonary hypertension, Riociguat, Registry, Clinical practice, Safety

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Article 106241- février 2021 Retour au numéro

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Riociguat treatment in patients with pulmonary arterial hypertension: Final safety data from the EXPERT registry - 23/02/21

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