Abstract
| Original language | English |
|---|---|
| Article number | 106220 |
| Journal | Respiratory medicine |
| Volume | 178 |
| DOIs | |
| Publication status | Published - 1 Mar 2021 |
UN SDGs
This output contributes to the following UN Sustainable Development Goals (SDGs)
-
SDG 3 Good Health and Well-being
Keywords
- Chronic thromboembolic pulmonary hypertension
- Clinical practice
- Real-world
- Registry
- Riociguat
- Safety
Access to Document
Other files and links
Fingerprint
Dive into the research topics of 'Riociguat treatment in patients with chronic thromboembolic pulmonary hypertension: Final safety data from the EXPERT registry'. Together they form a unique fingerprint.Cite this
- APA
- Author
- BIBTEX
- Harvard
- Standard
- RIS
- Vancouver
}
In: Respiratory medicine, Vol. 178, 106220, 01.03.2021.
Research output: Contribution to journal › Article › Academic › peer-review
TY - JOUR
T1 - Riociguat treatment in patients with chronic thromboembolic pulmonary hypertension: Final safety data from the EXPERT registry
AU - Ghofrani, Hossein-Ardeschir
AU - Gomez Sanchez, Miguel-Angel
AU - Humbert, Marc
AU - Pittrow, David
AU - Simonneau, G. rald
AU - Gall, Henning
AU - Grünig, Ekkehard
AU - Klose, Hans
AU - Halank, Michael
AU - Langleben, David
AU - Snijder, Repke J.
AU - Escribano Subias, Pilar
AU - Mielniczuk, Lisa M.
AU - Lange, Tobias J.
AU - Vachiéry, Jean-Luc
AU - Wirtz, Hubert
AU - Helmersen, Douglas S.
AU - Tsangaris, Iraklis
AU - Barberá, Joan A.
AU - Pepke-Zaba, Joanna
AU - Boonstra, Anco
AU - Rosenkranz, Stephan
AU - Ulrich, Silvia
AU - Steringer-Mascherbauer, Regina
AU - Delcroix, Marion
AU - Jansa, Pavel
AU - Šimková, Iveta
AU - Giannakoulas, George
AU - Klotsche, Jens
AU - Williams, Evgenia
AU - Meier, Christian
AU - Hoeper, Marius M.
AU - Caneva, Jorge
AU - Tuhay, Graciela
AU - Diez, Mirta
AU - Talavera, Maria Lujan
AU - Acosta, Adriana
AU - Vulcano, Norberto
AU - Bosio, Martin
AU - Maldonado, Lorena
AU - Deleo, Sabino
AU - Melatini, Luciano
AU - Keogh, Anne
AU - Kotlyar, Eugene
AU - Feenstra, John
AU - Dwyer, Nathan
AU - Adams, Heath
AU - Stevens, Wendy
AU - Steele, Peter
AU - Proudman, Susanna
AU - Minson, Robert
AU - Reeves, Glenn
AU - Lavender, Melanie
AU - Ng, Benjamin
AU - Mackenzie, Michele
AU - Barry, Lisa
AU - Gruenberger, Margarethe
AU - Huber, Charlotte
AU - Lang, Irene
AU - Tilea, Ioana
AU - Sadushi-Kolici, Roela
AU - Löffler-Ragg, Judith
AU - Feistmantl, Lisa-Theresa
AU - Evrard, Patrick
AU - Louis, Renaud
AU - Guiot, Julien
AU - Naldi, Marco
AU - de Pauw, Michel
AU - Mehta, Sanjay
AU - Camacho, Rafael Conde
AU - Tovar, Patricia Parada
AU - Londoño, Alejandro
AU - Campo, Felipe
AU - Garcia, Paula
AU - Lema, Camila
AU - Orozco-Levi, Mauricio
AU - Martinez, William
AU - Gomez, Juan Esteban
AU - Nielsen-Kudsk, Jens Erik
AU - Mellemkjaer, Soren
AU - Anton, Ly
AU - Altraja, Alan
AU - Vihinen, Tapani
AU - Vasankari, Tuija
AU - Sitbon, Olivier
AU - Cottin, Vincent
AU - Têtu, Laurent
AU - Noël-Savina, Elise
AU - Shearman, Nicole
AU - Tayler, Susanne
AU - Olzik, Ilona
AU - Kulka, Christine
AU - Grimminger, Jan
AU - Simon, Marcel
AU - Nolde, Anna
AU - Oqueka, Tim
AU - Harbaum, Lars
AU - Egenlauf, Benjamin
AU - Ewert, Ralf
AU - Schulz, Christian
AU - Regotta, Sabine
AU - Kramer, Tilmann
AU - Knoop-Busch, Susanne
AU - Gerhardt, Felix
AU - Konstantinides, Stavros
AU - Pitsiou, Georgia
AU - Stanopoulos, Ioannis
AU - Sourla, Evdokia
AU - Mouratoglou, Sofia
AU - Karvounis, Haralambos
AU - Pappas, Athanasios
AU - Georgopoulos, Dimitrios
AU - Fanaridis, Michail
AU - Mitrouska, Ioanna
AU - Michalis, Lampros
AU - Pappas, Konstantinos
AU - Kotsia, Anna
AU - Gaine, Sean
AU - Vizza, Carmine Dario
AU - Manzi, Giovanna
AU - Poscia, Roberto
AU - Badagliacca, Roberto
AU - Agostoni, Piergiuseppe
AU - Bruno, Noemi
AU - Farina, Stefania
AU - D'Alto, Michele
AU - Argiento, Paola
AU - Correra, Anna
AU - di Marco, Giovanni Maria
AU - Cresci, Chiara
AU - Vannucchi, Vieri
AU - Torricelli, Elena
AU - Garcea, Alessio
AU - Pesci, Alberto
AU - Sardella, Luca
AU - Paciocco, Giuseppe
AU - Pane, Federico
AU - D'Armini, Andrea Maria
AU - Pin, Maurizio
AU - Grazioli, Valentina
AU - Massola, Giulia
AU - Sciortino, Antonio
AU - Prediletto, Renato
AU - Bauleo, Carolina
AU - Airò, Edoardo
AU - Ndreu, Rudina
AU - Pavlickova, Ivana
AU - Lunardi, Claudio
AU - Mulè, Massimiliano
AU - Farruggio, Silvia
AU - Costa, Serena
AU - Galgano, Giuseppe
AU - Petruzzi, Mario
AU - de Luca, Anna
AU - Lombardi, Francesco
AU - Roncon, Loris
AU - Conte, Luca
AU - Picariello, Claudio
AU - Wirtz, Gil
AU - Alexandre, Myriam
AU - Vonk-Noordegraaf, A.
AU - Boogaard, H.
AU - Mager, J.
AU - Reesink, H.
AU - van den Toorn, Leon M.
AU - Boomars, Karin
AU - Andreassen, Arne K.
AU - Castro, Graça
AU - Tania, Gonçalves
AU - Baptista, Rui
AU - Marinho, António
AU - Shiang, Teresa
AU - Oliveira, Ana
AU - Coutinho, Daniel
AU - Sousa, Joana
AU - Loureiro, Maria José
AU - Repolho, D. bora
AU - Martins Jesus, Susana Maria
AU - Capinha, Marta
AU - Agostinho, João
AU - Cardoso, Tania
AU - Rocha, Andreia
AU - Espinha, Mafalda
AU - Ivanov, Kyundyul Ivanovich
AU - Alexeeva, Dalyana Eduardovna
AU - Batalina, Marina Vadimovna
AU - Hegya, Daria Viktorovna
AU - Zvereva, Tatyana Nikolaevna
AU - Avdeev, Sergey Nikolaevich
AU - Tsareva, Natalia Anatolievna
AU - Galyavich, Albert Sarvatovich
AU - Nikolaevich, Bykov Aleksander
AU - Filippov, Evgeny Vladimirovich
AU - Yakovleva, Olga Eduardovna
AU - Pavlova, Olga Borisovna
AU - Skripkina, Elena Sergeevna
AU - Martynyuk, Tamila Vitalievna
AU - Bukatova, Irina Fedorovna
AU - Tregubova, Anna Viktorovna
AU - Platonov, Dmitry Yurievich
AU - Kolomeytseva, Tatyana Mikhaylovna
AU - Al Dalaan, Abdullah
AU - Abdelsayed, Abeer Abeer
AU - Weheba, Ihab
AU - Saleemi, Sarferaz
AU - Sakkijha, Hussam
AU - Bohacekova, Marcela
AU - Valkovicova, Tatiana
AU - Farkasova, Iveta
AU - Quezada, Carlos Andres
AU - Piccari, Lucilla
AU - Blanco, Isabel
AU - Sebastian, Laura
AU - Roman, Antonio
AU - Lopez, Manuel
AU - Otero, Remedios
AU - Elias, Teresa
AU - Jara, Luis
AU - Asencio, Isabel
AU - Arjona, Josefa Jiménez
AU - Almagro, Raúl Menor
AU - Cárdenas, Salvador L. pez
AU - García, Salvador Alcaraz
AU - Rodríguez, Patricia Villanueva
AU - Lopez, Raquel
AU - Garcia, Alberto
AU - Avilés, Francisco Fernandez
AU - de la Pava, Sebastian
AU - Yotti, Raquel
AU - Peñate, Gregorio P. rez
AU - Marrero, Fernando León
AU - Cifrián Martínez, José Manuel
AU - Martinez-Meñaca, Amaya
AU - Alonso, Lecue Pilar
AU - Rozas, Sonia Fernandez
AU - Fernandez, David Iturbe
AU - Cuesta, Victor Mora
AU - Söderberg, Stefan
AU - Bartfay, Sven-Erik
AU - Rundqvist, Bengt
AU - Alfetlawi, Monthir
AU - Wodlin, Peter
AU - Schwarz, Esther Irene
AU - Speich, Rudolf
AU - Lador, Frédéric
AU - Rochat, Thierry
AU - Gasche-Soccal, Paola
AU - Hsu, Chih-Hsin
AU - Lin, Tsung-Hsien
AU - Su, Ho-Ming
AU - Lai, Wen-Ter
AU - Chu, Chun Yuan
AU - Hsu, Po-Chao
AU - Voon, Wen-Chol
AU - Yen, Hsueh-Wei
AU - Yih-Jer Wu, Jacob
AU - Wu, Shu-Hao
AU - Huang, Wen-Pin
AU - Fong, Man-Cai
AU - Huang, Chien-Lung
AU - Kuo, Ping-Hung
AU - Lin, Yen-Hung
AU - Lin, Jiunn-Lee
AU - Hung, Chi-Sheng
AU - Wu, Cho-Kai
AU - Sung, Shih-Hsien
AU - Huang, Wei-Chun
AU - Cheng, Chin-Chang
AU - Kuo, Shu-Hung
AU - Wang, Wen-Hwa
AU - Ho, Wan-Jing
AU - Hsu, Tsu-Shiu
AU - Mutlu, B. lent
AU - Atas, Halil
AU - Ongen, Gul
AU - Un, Zeynep
AU - Okumus, Gulfer
AU - Hanta, Ismail
AU - Corris, Paul
AU - Peacock, Andrew
AU - Church, Colin
AU - NEW COLLABORATORS LIST
AU - Toshner, Mark
AU - Newnham, Michael
N1 - Funding Information: The EXPERT registry was funded by Bayer AG (Berlin, Germany) and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc., Kenilworth, NJ, USA. The authors acknowledge the database administration by Torsten Tille, Dresden, and the project administration of Mrs Romy Hoppenz and Mrs Linda Kottke at GWT-TUD GmbH, Dresden. Medical writing services provided by Richard Murphy PhD of Adelphi Communications Ltd, Macclesfield, UK were funded by Bayer AG in accordance with Good Publication Practice (GPP3) guidelines. Funding Information: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Prof Marius M. Hoeper reports personal fees from Bayer AG, during the conduct of the study; personal fees from Actelion, personal fees from Acceleron, personal fees from MSD, personal fees from Jansen, personal fees from Pfizer, outside the submitted work. Dr Hans Klose reports speaker and consultancy fees from Actelion, Bayer AG, GSK, Novartis, Pfizer, and United Therapeutics and research support from Actelion, Bayer AG, GSK, Pfizer, and MSD. Dr Michael Halank reports personal fees and non-financial support from Actelion, AstraZeneca, Bayer AG, Berlin-Chemie, GSK, OMT, MSD, and Novartis. Dr George Giannakoulas reports speaker and consultancy fees from Actelion, Bayer, ELPEN Pharmaceuticals, GSK, Pfizer, Lilly, and United Therapeutics, and research support from GSK, ELPEN Pharmaceuticals, and Galenica. Dr Henning Gall has received honoraria and/or other support from Actelion, AstraZeneca, Bayer, BMS, GSK, Janssen-Cilag, Lilly, MSD, Novartis, OMT, Pfizer, and United Therapeutics. Dr Pavel Jansa reports consultancy and speaker fees from MSD, AOP Orphan, and Actelion. Prof Ekkehard Grünig reports research grants and speaker honoraria/consultancy fees from Actelion and Bayer/MSD, research grants from GSK, United Therapeutics, Bellerophon, OMT GmbH, Pfizer, Reata, and Novartis, and speaker honoraria from Bial, Medscape, and OrPha Swiss GmbH. Prof David Pittrow reports personal fees from Actelion, Bayer AG, Aspen, Boehringer Ingelheim, Sanofi, Biogen, Shire, and MSD outside the submitted work. Silvia Ulrich reports research grants and personal fees from Actelion, Bayer, MSD, and Orpha Swiss. Tobias J. Lange has received personal fees from Actelion, MSD, Pfizer, and OMT orphan. Dr Iraklis Tsangaris reports speaker and consultancy fees from Actelion, Bayer AG, ELPEN, GSK, MSD, Pfizer, and United Therapeutics. Stephan Rosenkranz reports remunerations for lectures and/or consultancy from Abbott, Actelion, Arena, Bayer, Ferrer, GSK, MSD, Novartis, Pfizer, and United Therapeutics; and research support to his institution from Actelion, Bayer, Novartis, Pfizer, and United Therapeutics. Repke J. Snijder reports grants from Pfizer and Actelion Pharmaceuticals. Prof Iveta Šimková reports consultancy and speaker fees from MSD, AOP Orphan, and Actelion. Dr Marc Humbert reports grants and personal fees from Bayer and GSK, and personal fees from Actelion, Merck, and United Therapeutics. Marion Delcroix has received investigator, speaker, consultant, and steering committee member fees from Actelion, Bayer AG, Bellerophon, Eli Lilly, GlaxoSmithKline, MSD, Pfizer, and Reata, and research grants from Actelion. Joan A. Barberà reports receipt of honoraria for consultation or speaker fees from Actelion and Merck; and research support through his institution from Actelion, Merck, GlaxoSmithKline, and Ferrer. Joanna Pepke-Zaba reports research grants and speaker honoraria/consultancy fees from Actelion, Bayer/MSD, and GSK. Jean-Luc Vachiéry reports ongoing consultancies to Actelion, Sonnivie, Arena Pharma, Bial Portela, and Respira Therapeutics, past consultancies to AstraZeneca, BayerShering, CardioMEMS, GlaxoSmithKline, Pfizer, Merck, and United Therapeutics, and current membership of an advisory board or similar group for Actelion and GlaxoSmithKline. Jean-Luc Vachiéry's institution receives funding from Actelion Pharmaceuticals for performing clinical studies. Regina Steringer-Mascherbauer, Jens Klotsche, and Miguel-Angel Gomez Sanchez have no conflicts of interest relevant to the EXPERT study. Hossein-Ardeschir Ghofrani reports personal fees for advisory board work, and payment for lectures including service on speaker bureaus, from Actelion, Bayer, GSK, Novartis, and Pfizer; consultancy fees from Actelion, Bayer, Bellerophon Pulse Technologies, GSK, MSD, Novartis, and Pfizer; and grants from Deutsche Forschungsgemeinschaft (DFG). Pilar Escribano Subias reports personal fees from Actelion, Bayer AG, GlaxoSmithKline, and Merck Sharp & Dohme, and grants from Actelion, Bayer AG, GlaxoSmithKline, and Ferrer, outside the submitted work. Gérald Simonneau reports personal fees and non-financial support from Actelion, personal fees and non-financial support from Bayer, personal fees and non-financial support from MSD, outside the submitted work. Douglas S. Helmersen reports industry-sponsored research with Bayer AG, United Therapeutics, and Gilead Sciences, Inc., and advisory board/speaker fees from Bayer AG and Actelion. David Langleben reports honoraria, consultation fees, research support, and/or travel expenses from Actelion, Arena, Bayer AG, Northern Therapeutics, PhaseBio, Acceleron, Janssen, and United Therapeutics. Anco Boonstra reports consultancy fees from Pfizer BV and hospitality from Teva Nederland. Lisa M. Mielniczuk reports speaker fees and honoraria from Bayer AG, and speaker fees, consultancy fees, and travel fees from Actelion. Evgenia Williams and Christian Meier are employees of Bayer AG. Publisher Copyright: © 2020 The Authors Copyright: Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/3/1
Y1 - 2021/3/1
N2 - 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.
AB - 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.
KW - Chronic thromboembolic pulmonary hypertension
KW - Clinical practice
KW - Real-world
KW - Registry
KW - Riociguat
KW - Safety
UR - https://www.scopus.com/pages/publications/85100409820
UR - https://www.ncbi.nlm.nih.gov/pubmed/33540340
UR - https://www.scopus.com/pages/publications/85100409820
U2 - 10.1016/j.rmed.2020.106220
DO - 10.1016/j.rmed.2020.106220
M3 - Article
C2 - 33540340
SN - 0954-6111
VL - 178
JO - Respiratory medicine
JF - Respiratory medicine
M1 - 106220
ER -