; Jansa, Pavel
; Šimková, Iveta ; Giannakoulas, George ; Klotsche, Jens ; Williams, Evgenia ; Meier, Christian ; Ghofrani, Hossein-Ardeschir ; Caneva, Jorge ; Tuhay, Graciela ; Diez, Mirta ; Talavera, Maria Lujan ; Acosta, Adriana ; Vulcano, Norberto ; Bosio, Martin ; Maldonado, Lorena ; Deleo, Sabino ; Melatini, Luciano ; Keogh, Anne ; Kotlyar, Eugene ; Feenstra, John ; Dwyer, Nathan ; Adams, Heath ; Stevens, Wendy ; Steele, Peter ; Proudman, Susanna ; Minson, Robert ; Reeves, Glenn ; Lavender, Melanie ; Ng, Benjamin ; Mackenzie, Michele ; Barry, Lisa ; Gruenberger, Margarethe ; Huber, Charlotte ; Lang, Irene ; Tilea, Ioana ; Sadushi-Kolici, Roela ; Löffler-Ragg, Judith ; Feistmantl, Lisa-Theresa ; Evrard, Patrick ; Guiot, Julien ; Naldi, Marco ; De Pauw, Michel ; Louis, Renaud ; Mehta, Sanjay ; Camacho, Rafael Conde ; Tovar, Patricia Parada ; Londoño, Alejandro ; Campo, Felipe ; Garcia, Paula ; Lema, Camila ; Orozco-Levi, Mauricio ; Martinez, William ; Gomez, Juan Esteban ; Nielsen-Kudsk, Jens Erik ; Mellemkjaer, Soren ; Anton, Ly ; Altraja, Alan ; Vihinen, Tapani ; Vasankari, Tuija ; Sitbon, Olivier ; Cottin, Vincent ; Têtu, Laurent ; Noël-Savina, Elise ; Shearman, Nicole ; Tayler, Susanne ; Olzik, Ilona ; Kulka, Christine ; Grimminger, Jan ; Simon, Marcel ; Nolde, Anna ; Oqueka, Tim ; Harbaum, Lars ; Egenlauf, Benjamin ; Ewert, Ralf ; Schulz, Christian ; Regotta, Sabine ; Kramer, Tilmann ; Knoop-Busch, Susanne ; Gerhardt, Felix ; Konstantinides, Stavros ; Pitsiou, Georgia ; Stanopoulos, Ioannis ; Sourla, Evdokia ; Mouratoglou, Sofia ; Karvounis, Haralambos ; Pappas, Athanasios ; Mitrouska, Ioanna ; Georgopoulos, Dimitrios ; Fanaridis, Michail ; Michalis, Lampros ; Pappas, Konstantinos ; Kotsia, Anna ; Gaine, Sean ; Vizza, Carmine Dario ; Manzi, Giovanna ; Poscia, Roberto ; Badagliacca, Roberto ; Agostoni, Piergiuseppe ; Bruno, Noemi ; Farina, Stefania ; D'Alto, Michele ; Argiento, Paola ; Correra, Anna ; Di Marco, Giovanni Maria ; Cresci, Chiara ; Vannucchi, Vieri ; Torricelli, Elena ; Garcea, Alessio ; Pesci, Alberto ; Sardella, Luca ; Paciocco, Giuseppe ; Pane, Federico ; D'Armini, Andrea Maria ; Pin, Maurizio ; Grazioli, Valentina ; Massola, Giulia ; Sciortino, Antonio ; Prediletto, Renato ; Bauleo, Carolina ; Airò, Edoardo ; Ndreu, Rudina ; Pavlickova, Ivana ; Lunardi, Claudio ; Farruggio, Silvia ; Costa, Serena ; Mulè, Massimiliano ; Galgano, Giuseppe ; Petruzzi, Mario ; De Luca, Anna ; Lombardi, Francesco ; Roncon, Loris ; Conte, Luca ; Picariello, Claudio ; Wirtz, Gil ; Alexandre, Myriam ; Vonk-Noordegraaf, A. ; Boogaard, H. ; Mager, J. ; Reesink, H. ; van den Toorn, Leon M. ; Boomars, Karin ; Andreassen, Arne K. ; Castro, Graça ; Tania, Gonçalves ; Baptista, Rui ; Marinho, António ; Shiang, Teresa ; Oliveira, Ana ; Coutinho, Daniel ; Sousa, Joana ; Loureiro, Maria José ; Repolho, Débora ; Martins Jesus, Susana Maria ; Capinha, Marta ; Agostinho, João ; Cardoso, Tania ; Rocha, Andreia ; Espinha, Mafalda ; Ivanov, Kyundyul Ivanovich ; Alexeeva, Dalyana Eduardovna ; Batalina, Marina Vadimovna ; Hegya, Daria Viktorovna ; Zvereva, Tatyana Nikolaevna ; Avdeev, Sergey Nikolaevich ; Tsareva, Natalia Anatolievna ; Galyavich, Albert Sarvatovich ; Nikolaevich, Bykov Aleksander ; Filippov, Evgeny Vladimirovich ; Yakovleva, Olga Eduardovna ; Pavlova, Olga Borisovna ; Skripkina, Elena Sergeevna ; Martynyuk, Tamila Vitalievna ; Bukatova, Irina Fedorovna ; Tregubova, Anna Viktorovna ; Platonov, Dmitry Yurievich ; Kolomeytseva, Tatyana Mikhaylovna ; Al Dalaan, Abdullah ; Abdelsayed, Abeer Abeer ; Weheba, Ihab ; Saleemi, Sarferaz ; Sakkijha, Hussam ; Bohacekova, Marcela ; Valkovicova, Tatiana ; Farkasova, Iveta ; Quezada, Carlos Andres ; Piccari, Lucilla ; Blanco, Isabel ; Sebastian, Laura ; Roman, Antonio ; Lopez, Manuel ; Otero, Remedios ; Elias, Teresa ; Jara, Luis ; Asencio, Isabel ; Arjona, Josefa Jiménez ; Almagro, Raúl Menor ; Cárdenas, Salvador López ; García, Salvador Alcaraz ; Rodríguez, Patricia Villanueva ; Lopez, Raquel ; Garcia, Alberto ; Avilés, Francisco Fernandez ; De La Pava, Sebastian ; Yotti, Raquel ; Peñate, Gregorio Pérez ; Marrero, Fernando León ; Cifrián Martínez, José Manuel ; Martinez-Meñaca, Amaya ; Alonso, Lecue Pilar ; Rozas, Sonia Fernandez ; Fernandez, David Iturbe ; Cuesta, Victor Mora ; Söderberg, Stefan ; Bartfay, Sven-Erik ; Rundqvist, Bengt ; Alfetlawi, Monthir ; Wodlin, Peter ; Schwarz, Esther Irene ; Speich, Rudolf ; Lador, Frédéric ; Rochat, Thierry ; Gasche-Soccal, Paola ; Hsu, Chih-Hsin ; Lin, Tsung-Hsien ; Su, Ho-Ming ; Lai, Wen-Ter ; Chu, Chun Yuan ; Hsu, Po-Chao ; Voon, Wen-Chol ; Yen, Hsueh-Wei ; Yih-Jer Wu, Jacob ; Wu, Shu-Hao ; Huang, Wen-Pin ; Fong, Man-Cai ; Huang, Chien-Lung ; Kuo, Ping-Hung ; Lin, Yen-Hung ; Lin, Jiunn-Lee ; Hung, Chi-Sheng ; Wu, Cho-Kai ; Sung, Shih-Hsien ; Huang, Wei-Chun ; Cheng, Chin-Chang ; Kuo, Shu-Hung ; Wang, Wen-Hwa ; Ho, Wan-Jing ; Hsu, Tsu-Shiu ; Mutlu, Bülent ; Atas, Halil ; Ongen, Gul ; Un, Zeynep ; Okumus, Gulfer ; Hanta, Ismail ; Corris, Paul ; Peacock, Andrew ; Church, Colin ; Toshner, Mark ; Newnham, Michael | Item type: | Article | ||||
|---|---|---|---|---|---|
| Journal or Publication Title: | Respiratory Medicine | ||||
| Publisher: | W B SAUNDERS CO LTD | ||||
| Place of Publication: | LONDON | ||||
| Volume: | 177 | ||||
| Page Range: | p. 106241 | ||||
| Date: | 2021 | ||||
| Institutions: | Medicine > Lehrstuhl für Innere Medizin II | ||||
| Identification Number: |
| ||||
| Keywords: | LONG-TERM EXTENSION; OPEN-LABEL; OUTCOMES; PREDICTORS; SURVIVAL; Pulmonary arterial hypertension; Pulmonary hypertension; Riociguat; Registry; Clinical practice; Safety | ||||
| Dewey Decimal Classification: | 600 Technology > 610 Medical sciences Medicine | ||||
| Status: | Published | ||||
| Refereed: | Yes, this version has been refereed | ||||
| Created at the University of Regensburg: | Yes | ||||
| Item ID: | 56791 |
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 ...

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.
Metadata last modified: 29 Feb 2024 12:38
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