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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 2nd 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.

Le texte complet de cet article est disponible en PDF.

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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Vol 177

Article 106241- février 2021 Retour au numéro
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