Accès ouvert déclaré
2020
article
Riociguat treatment in patients with pulmonary arterial hypertension: Final safety data from the EXPERT registry
Marius M. Hoeper, Marc Humbert, David Pittrow, Gérald Simonneau, Henning Gall, Ekkehard Grünig, Hans Klose, Michael Halank, David Langleben, Repke J. Snijder, Pilar Escribano Subías, Lisa Mielniczuk, Tobias Lange, Jean‐Luc Vachiéry, Hubert Wirtz, Douglas Helmersen, Iraklis Tsangaris, Joan Albert Barberà, Joanna Pepke‐Żaba, Anco Boonstra, Stephan Rosenkranz, Silvia Ulrich, Regina Steringer‐Mascherbauer, Marion Delcroix, Pavel Jansa, Iveta Šimková, George Giannakoulas, Jens Klotsche, Christian Meier, Jorge Cáneva, Graciela Tuhay, Mirta Díez, María L. Talavera, Adriana Acosta, Norberto Vulcano, Martín Bosio, Lorena Maldonado, Sabino Deleo, Luciano Melatini, Anne Keogh, Eugene Kotlyar, John Feenstra, Nathan Dwyer, Heath Adams, Wendy Stevens, Peter Steele, Susanna Proudman, Robert Minson, Glenn Reeves, Melanie Lavender, Benjamin Ng, Michele Mackenzie, Lisa C. Barry, Margarethe Gruenberger, Charlotte Huber, Iréne Lang, Ioana Tilea, Roela Sadushi‐Kolici, Judith Löffler‐Ragg, Lisa-Theresa Feistmantl, P Evrard, Julien Guiot, Marco Naldi, Michel De Pauw, Renaud Louis, Sanjay Mehta, Rafael Conde Camacho, Patricia Parada Tovar, Alejandro Londoño, Felipe Campo, Paula Andrea Gaviria García, Camila Lema, Mauricio Orozco‐Levi, William Martínez, Jens Erik Nielsen‐Kudsk, Søren Mellemkjær, Ly Anton, Alan Altraja, Tapani Vihinen, Tuija Vasankari, Olivier Sitbon, Vincent Cottin, L. Têtu, Elise Noël‐Savina, Nicole Shearman, Susanne Tayler, Ilona Olzik, Christine Kulka, Jan Grimminger, Marcel Simon, Anna Nolde, Tim Oqueka, Lars Harbaum, Benjamin Egenlauf, Ralf Ewert, Christian Schulz, Sabine Regotta, Tilmann Kramer, Susanne Knoop-Busch, Felix Gerhardt, Stavros Konstantinides, Georgia Pitsiou, Ioannis Stanopoulos, Evdokia Sourla, S. A. Mouratoglou, Haralambos Karvounis, Athanasios Pappas, Ioanna Mitrouska, Dimitrios Georgopoulos, Michail Fanaridis, Lampros K. Michalis, Κωνσταντίνος Παππάς, Anna Kotsia, Seán Gaine, Carmine Dario Vizza, Giovanna Manzi, Roberto Poscia, Roberto Badagliacca, Piergiuseppe Agostoni, Noemi Bruno, Stefania Farina, Michele D’Alto, Paola Argiento, Anna Correra, Giovanni Maria Di Marco, Chiara Cresci, Vieri Vannucchi, Elena Torricelli, Alessio Garcea, Alberto Pesci, Luca Sardella, Giuseppe Paciocco, Federico Pane, Andrea Maria D’Armini, Maurizio Pin, Valentina Grazioli, Giulia Massola, Antonio Sciortino, Renato Prediletto, Carolina Bauleo, Edoardo Airò, Rudina Ndreu, Ivana Pavlickova, Claudio Lunardi, Silvia Farruggio, Serena Costa, Massimiliano Mulè, Giuseppe Galgano, Mario Petruzzi, Anna De Luca, Francesco Lombardi, Loris Roncon, Luca Conte, Claudio Picariello, Gil Wirtz, Myriam Alexandre, Anton Vonk Noordegraaf, H. Boogaard, Johannes J. Mager, Herre J. Reesink, Leon M. van den Toorn, Karin A. Boomars, Graça Castro, Gonçalves Tania, Rui Baptista, António Marinho, Teresa Shiang, Ana de Oliveira, Daniel Coutinho, Joana Sousa, María José Loureiro, Débora Repolho, Susana Jesus, Marta Capinha, João Agostinho, Tânia Aparecida Marchiori Oliveira Cardoso, Andréia Silva da Rocha, Mafalda Espinha, K. I. Ivanov, Dalyana Eduardovna Alexeeva, Marina Vadimovna Batalina, D. Hegya, T. N. Zvereva, С. Н. Авдеев, Н. А. Царева, Albert Sarvatovich Galyavich, Bykov Aleksander Nikolaevich, Е В Филиппов, Olga Eduardovna Yakovleva, Olga Borisovna Pavlova, Elena Skripkina, T. V. Martynyuk, Irina Fedorovna Bukatova, Anna Viktorovna Tregubova, Dmitry Yurievich Platonov, Tatyana Mikhaylovna Kolomeytseva, Abdullah Al Dalaan, A A Abd-Elsayed, Ihab Weheba, Sarferaz Saleemi, Hussam Sakkijha, Marcela Boháčeková, Tatiana Valkovičová, Iveta Farkasova, Carlos Andrés Quezada, Lucilla Piccari, Isabel Blanco, Laura Sebastián, Antonio Román, Manuel López, Remedios Otero, Teresa Elías-Hernández, Isabel Asencio, Josefa Jiménez Arjona, Raúl Menor Almagro, Salvador López-Cárdenas, Salvador Alcaraz García, Patricia Villanueva Rodríguez, Raquel López, Alberto E. García, Francisco Fernández‐Avilés, Sebastian De La Pava, Raquel Yotti, Gregorio Pérez Peñate, Fernando León Marrero, José M. Cifrián, Amaya Martínez Meñaca, Lecue Pilar Alonso, Sonia Fernández Rozas, David Iturbe‐Fernández, V.M. Mora Cuesta, Stefan Söderberg, S. Bartfay, Bengt Rundqvist, Monthir Alfetlawi, Peter Wodlin, Esther I. Schwarz, Rudolf Speich, Frédéric Lador, Thierry Rochat, Paola Gasche‐Soccal, Chih‐Hsin Hsu, Tsung‐Hsien Lin, Ho‐Ming Su, Wen‐Ter Lai, Chun Yuan Chu, Po‐Chao Hsu, Wen‐Chol Voon, Hsueh‐Wei Yen, Jacob Yih-Jer Wu, Shu‐Hao Wu, Wen-Pin Huang, Man-Cai Fong, Chien-Lung Huang, Ping‐Hung Kuo, Yen‐Hung Lin, Jiunn‐Lee Lin, Chi‐Sheng Hung, Cho‐Kai Wu, Shih‐Hsien Sung, Wei‐Chun Huang, Chin-Chang Cheng, Shu‐Hung Kuo, Wen-Hwa Wang, Wan‐Jing Ho, Tsu‐Shiu Hsu, Bülent Mutlu, Gül Öngen, Zeynep Un, Gülfer Okumuş, İsmail Hanta, Paul A. Corris, Andrew J. Peacock, Colin Church, Mark Toshner, Michael Newnham
24Citations signalées — pas une note de qualité
38Institutions déclarées
13Pays d’affiliation déclarés
Résumé fourni par la source
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.
Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.
Contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Riociguat treatment in patients with pulmonary arterial hypertension: Final safety data from the EXPERT registry
- Date Crossref
- 01/02/2021
- Éditeur
- Elsevier BV
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude et ne compte pas comme une seconde source scientifique indépendante.
Institutions déclarées
Une affiliation ne permet pas de déduire la nationalité d’un auteur.
Sujets associés
Pulmonary Hypertension Research and TreatmentsChronic Obstructive Pulmonary Disease (COPD) ResearchInterstitial Lung Diseases and Idiopathic Pulmonary Fibrosis