Riociguat treatment in patients with chronic thromboembolic pulmonary hypertension: Final safety data from the EXPERT registry.
Aged
Chronic Disease
Data Analysis
Female
Humans
Hypertension, Pulmonary
/ drug therapy
Male
Middle Aged
Multicenter Studies as Topic
Prospective Studies
Pulmonary Embolism
/ complications
Pyrazoles
/ adverse effects
Pyrimidines
/ adverse effects
Randomized Controlled Trials as Topic
Recurrence
Registries
Safety
Time Factors
Treatment Outcome
Chronic thromboembolic pulmonary hypertension
Clinical practice
Real-world
Registry
Riociguat
Safety
Journal
Respiratory medicine
ISSN: 1532-3064
Titre abrégé: Respir Med
Pays: England
ID NLM: 8908438
Informations de publication
Date de publication:
03 2021
03 2021
Historique:
received:
17
05
2020
revised:
05
11
2020
accepted:
06
11
2020
pubmed:
5
2
2021
medline:
9
10
2021
entrez:
4
2
2021
Statut:
ppublish
Résumé
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. 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. 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]). 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.
Identifiants
pubmed: 33540340
pii: S0954-6111(20)30360-7
doi: 10.1016/j.rmed.2020.106220
pii:
doi:
Substances chimiques
Pyrazoles
0
Pyrimidines
0
riociguat
RU3FE2Y4XI
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
106220Investigateurs
Jorge Caneva
(J)
Graciela Tuhay
(G)
Mirta Diez
(M)
Maria Lujan Talavera
(ML)
Adriana Acosta
(A)
Norberto Vulcano
(N)
Martin Bosio
(M)
Lorena Maldonado
(L)
Sabino Deleo
(S)
Luciano Melatini
(L)
Anne Keogh
(A)
Eugene Kotlyar
(E)
John Feenstra
(J)
Nathan Dwyer
(N)
Heath Adams
(H)
Wendy Stevens
(W)
Peter Steele
(P)
Susanna Proudman
(S)
Robert Minson
(R)
Glenn Reeves
(G)
Melanie Lavender
(M)
Benjamin Ng
(B)
Michele Mackenzie
(M)
Lisa Barry
(L)
Margarethe Gruenberger
(M)
Charlotte Huber
(C)
Irene Lang
(I)
Ioana Tilea
(I)
Roela Sadushi-Kolici
(R)
Judith Löffler-Ragg
(J)
Lisa-Theresa Feistmantl
(LT)
Patrick Evrard
(P)
Renaud Louis
(R)
Julien Guiot
(J)
Marco Naldi
(M)
Michel De Pauw
(M)
Sanjay Mehta
(S)
Rafael Conde Camacho
(RC)
Patricia Parada Tovar
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Alejandro Londoño
(A)
Felipe Campo
(F)
Paula Garcia
(P)
Camila Lema
(C)
Mauricio Orozco-Levi
(M)
William Martinez
(W)
Juan Esteban Gomez
(JE)
Jens Erik Nielsen-Kudsk
(JE)
Soren Mellemkjaer
(S)
Ly Anton
(L)
Alan Altraja
(A)
Tapani Vihinen
(T)
Tuija Vasankari
(T)
Olivier Sitbon
(O)
Vincent Cottin
(V)
Laurent Têtu
(L)
Elise Noël-Savina
(E)
Nicole Shearman
(N)
Susanne Tayler
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(I)
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(S)
Felix Gerhardt
(F)
Stavros Konstantinides
(S)
Georgia Pitsiou
(G)
Ioannis Stanopoulos
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Evdokia Sourla
(E)
Sofia Mouratoglou
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Haralambos Karvounis
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(EV)
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(AA)
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Informations de copyright
Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.