Hoeper, Marius M., 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 Ghofrani, Hossein-Ardeschir (2021). Riociguat treatment in patients with pulmonary arterial hypertension: Final safety data from the EXPERT registry. Respir. Med., 177. 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 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.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Hoeper, Marius M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
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
Ghofrani, Hossein-ArdeschirUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-607516
DOI: 10.1016/j.rmed.2020.106241
Journal or Publication Title: Respir. Med.
Volume: 177
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; OPEN-LABEL; OUTCOMES; PREDICTORS; SURVIVALMultiple languages
Cardiac & Cardiovascular Systems; Respiratory SystemMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/60751

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