Ghofrani, Hossein-Ardeschir, Gomez Sanchez, Miguel-Angel, Humbert, Marc, Pittrow, David, Simonneau, Gerald, Gall, Henning, Gruenig, Ekkehard, Klose, Hans, Halank, Michael, Langleben, David, Snijder, Repke J., Subias, Pilar Escribano, Mielniczuk, Lisa M., Lange, Tobias J., Vachiery, Jean-Luc, Wirtz, Hubert, Helmersen, Douglas S., Tsangaris, Iraklis, Barbera, Joan A., Pepke-Zaba, Joanna, Boonstra, Anco, Rosenkranz, Stephan, Ulrich, Silvia, Steringer-Mascherbauer, Regina, Delcroix, Marion ORCID: 0000-0001-8394-9809, Jansa, Pavel ORCID: 0000-0002-3711-7064, Simkova, Iveta, Giannakoulas, George, Klotsche, Jens, Williams, Evgenia, Meier, Christian and Hoeper, Marius M. (2021). Riociguat treatment in patients with chronic thromboembolic pulmonary hypertension: Final safety data from the EXPERT registry. Respir. Med., 178. LONDON: W B SAUNDERS CO LTD. ISSN 1532-3064

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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 (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.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Ghofrani, Hossein-ArdeschirUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gomez Sanchez, Miguel-AngelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Humbert, MarcUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pittrow, DavidUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Simonneau, GeraldUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gall, HenningUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gruenig, EkkehardUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Klose, HansUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Halank, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Langleben, DavidUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Snijder, Repke J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Subias, Pilar EscribanoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mielniczuk, Lisa M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lange, Tobias J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vachiery, Jean-LucUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wirtz, HubertUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Helmersen, Douglas S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tsangaris, IraklisUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Barbera, Joan A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pepke-Zaba, JoannaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Boonstra, AncoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rosenkranz, StephanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ulrich, SilviaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Steringer-Mascherbauer, ReginaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Delcroix, MarionUNSPECIFIEDorcid.org/0000-0001-8394-9809UNSPECIFIED
Jansa, PavelUNSPECIFIEDorcid.org/0000-0002-3711-7064UNSPECIFIED
Simkova, IvetaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Giannakoulas, GeorgeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Klotsche, JensUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Williams, EvgeniaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Meier, ChristianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hoeper, Marius M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-607675
DOI: 10.1016/j.rmed.2020.106220
Journal or Publication Title: Respir. Med.
Volume: 178
Date: 2021
Publisher: W B SAUNDERS CO LTD
Place of Publication: LONDON
ISSN: 1532-3064
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
LONG-TERM EXTENSION; OUTCOMES; ENDARTERECTOMY; MANAGEMENT; DIAGNOSISMultiple languages
Cardiac & Cardiovascular Systems; Respiratory SystemMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/60767

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