Riociguat treatment in patients with chronic thromboembolic pulmonary hypertension: Final safety data from the EXPERT registry
Language English Country England, Great Britain Media print-electronic
Document type Journal Article, Research Support, Non-U.S. Gov't
PubMed
33540340
DOI
10.1016/j.rmed.2020.106220
PII: S0954-6111(20)30360-7
Knihovny.cz E-resources
- Keywords
- Chronic thromboembolic pulmonary hypertension, Clinical practice, Real-world, Registry, Riociguat, Safety,
- MeSH
- Data Analysis * MeSH
- Safety MeSH
- Time Factors MeSH
- Chronic Disease MeSH
- Middle Aged MeSH
- Humans MeSH
- Multicenter Studies as Topic MeSH
- Pulmonary Embolism complications drug therapy MeSH
- Hypertension, Pulmonary drug therapy etiology MeSH
- Prospective Studies MeSH
- Pyrazoles adverse effects therapeutic use MeSH
- Pyrimidines adverse effects therapeutic use MeSH
- Randomized Controlled Trials as Topic MeSH
- Recurrence MeSH
- Registries * MeSH
- Aged MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Names of Substances
- Pyrazoles MeSH
- Pyrimidines MeSH
- riociguat MeSH Browser
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.
Alberta Health Services University of Calgary Calgary Alberta Canada
Bayer AG Global Development Global Medical Affairs Berlin Germany
Centre for Pulmonary Hypertension Thoraxclinic at Heidelberg University Hospital Heidelberg Germany
Clinic of Pulmonology University Hospital Zurich Zurich Switzerland
Département de Cardiologie Cliniques Universitaires de Bruxelles Hôpital Erasme Brussels Belgium
Department of Cardiology 1 Aristotle University of Thessaloniki Thessaloniki Greece
Department of Pneumology University Medical Center Hamburg Eppendorf Hamburg Germany
Department of Pulmonology St Antonius Ziekenhuis Nieuwegein the Netherlands
Department of Respiratory Medicine University of Leipzig Leipzig Germany
German Rheumatism Research Center Berlin Leibniz Institute Berlin Germany
Institute for Clinical Pharmacology Technical University Dresden Germany
Medical Clinic 1 Department of Pneumology University Hospital Carl Gustav Carus Dresden Germany
Pulmonary Vascular Disease Unit Royal Papworth Hospital Cambridge UK
Respiratory Department Ramón y Cajal University Hospital Spain
Servicestelle für klinische Studien Krankenhaus der Elisabethinen Linz GmbH Linz Austria
University of Giessen and Marburg Lung Center Giessen Germany
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