dc.creator | Ghofrani, Hossein Ardeschir | es |
dc.creator | Gómez Sánchez, Miguel Ángel | es |
dc.creator | Humbert, Marc | es |
dc.creator | Pittrow, David | es |
dc.creator | Simonneau, Gérald | es |
dc.creator | Gall, Henning | es |
dc.creator | Otero Candelera, Remedios | es |
dc.creator | Hoeper, Marius M. | es |
dc.date.accessioned | 2022-09-23T13:51:41Z | |
dc.date.available | 2022-09-23T13:51:41Z | |
dc.date.issued | 2021 | |
dc.identifier.citation | Ghofrani, H.A., Gomez Sanchez, M.A., Humbert, M., Pittrow, D., Simonneau, G., Gall, H.,...,Hoeper, M.M. (2021). Riociguat treatment in patients with chronic thromboembolic pulmonary hypertension: Final safety data from the EXPERT registry. Respiratory Medicine, 178 | |
dc.identifier.issn | 0954-6111 (impreso) | es |
dc.identifier.issn | 1532-3064 (electrónico) | es |
dc.identifier.uri | https://hdl.handle.net/11441/137338 | |
dc.description.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. | es |
dc.format | application/pdf | es |
dc.format.extent | 11 p. | es |
dc.language.iso | eng | es |
dc.publisher | Elsevier | es |
dc.relation.ispartof | Respiratory Medicine, 178 | |
dc.rights | Attribution-NonCommercial-NoDerivatives 4.0 Internacional | * |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/4.0/ | * |
dc.subject | Chronic thromboembolic pulmonary | es |
dc.subject | Hypertension | es |
dc.subject | Riociguat | es |
dc.subject | Registry | es |
dc.subject | Real-world | es |
dc.subject | Clinical practice | es |
dc.subject | Safety | es |
dc.title | Riociguat treatment in patients with chronic thromboembolic pulmonary hypertension: Final safety data from the EXPERT registry | es |
dc.type | info:eu-repo/semantics/article | es |
dcterms.identifier | https://ror.org/03yxnpp24 | |
dc.type.version | info:eu-repo/semantics/publishedVersion | es |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | es |
dc.contributor.affiliation | Universidad de Sevilla. Departamento de Medicina | es |
dc.relation.publisherversion | https://www.sciencedirect.com/science/article/pii/S0954611120303607?via%3Dihub | es |
dc.identifier.doi | 10.1016/j.rmed.2020.106220 | es |
dc.journaltitle | Respiratory Medicine | es |
dc.publication.volumen | 178 | es |