Riociguat real-world use in patients with chronic thromboembolic pulmonary hypertension: A retrospective, observational cohort study in France.
Pulmonary embolism
Pulmonary hypertension
Real-world data
Riociguat
Soluble guanylate cyclase
Journal
Respiratory medicine and research
ISSN: 2590-0412
Titre abrégé: Respir Med Res
Pays: France
ID NLM: 101746324
Informations de publication
Date de publication:
Jun 2023
Jun 2023
Historique:
received:
31
01
2022
revised:
31
08
2022
accepted:
25
11
2022
medline:
9
6
2023
pubmed:
13
1
2023
entrez:
12
1
2023
Statut:
ppublish
Résumé
Riociguat is the first approved treatment for inoperable and persistent/recurrent post-surgery chronic thromboembolic pulmonary hypertension (CTEPH). The RetrospectIve Adempas® stuDy (RiAD) aimed to describe the real-world utilization of riociguat in France. In this retrospective multicentric study in patients initiating riociguat, dosing regimen, co-treatments and clinical characteristics were collected over a 2-year follow-up period. A total of 173 patients (mean age, 71.4 years; female, 63.0%; NYHA II-III, 80.3%) were included from January 2015 to December 2016 in 18 centers. All patients were diagnosed with CTEPH (75.7% inoperable and 20.8% with persistent/recurrent pulmonary hypertension [pH] after surgery) with mean (SD) right atrial pressure 7.6 (4.2) mmHg, mean pulmonary artery pressure 43.0 (11.4) mmHg and mean cardiac output 4.1 (1.1) L/min. Before riociguat initiation, 32.4% of patients previously received at least one pH-specific therapy. At initiation, 93.1% of patients were receiving anticoagulants and 83.2% were not receiving pH-specific co-treatments. Riociguat was initiated at 1 mg three times daily (t.i.d.) in 85.5% of patients and 82.1% were receiving 2.5 mg dose t.i.d. at 24 months. The maximal daily dose of 7.5 mg was never exceeded. At 24 months, the estimated rate of patients still taking riociguat was 78.8% with an estimated mean (SD) time on treatment of 20.1 (0.5) months per patient. No new safety signals were recorded. The results of this real-world study show that riociguat is used in France in accordance with its therapeutic indication in patients with inoperable or persistent/recurrent post-operative CTEPH and confirm its long-term safety.
Sections du résumé
BACKGROUND
BACKGROUND
Riociguat is the first approved treatment for inoperable and persistent/recurrent post-surgery chronic thromboembolic pulmonary hypertension (CTEPH). The RetrospectIve Adempas® stuDy (RiAD) aimed to describe the real-world utilization of riociguat in France.
METHODS
METHODS
In this retrospective multicentric study in patients initiating riociguat, dosing regimen, co-treatments and clinical characteristics were collected over a 2-year follow-up period.
RESULTS
RESULTS
A total of 173 patients (mean age, 71.4 years; female, 63.0%; NYHA II-III, 80.3%) were included from January 2015 to December 2016 in 18 centers. All patients were diagnosed with CTEPH (75.7% inoperable and 20.8% with persistent/recurrent pulmonary hypertension [pH] after surgery) with mean (SD) right atrial pressure 7.6 (4.2) mmHg, mean pulmonary artery pressure 43.0 (11.4) mmHg and mean cardiac output 4.1 (1.1) L/min. Before riociguat initiation, 32.4% of patients previously received at least one pH-specific therapy. At initiation, 93.1% of patients were receiving anticoagulants and 83.2% were not receiving pH-specific co-treatments. Riociguat was initiated at 1 mg three times daily (t.i.d.) in 85.5% of patients and 82.1% were receiving 2.5 mg dose t.i.d. at 24 months. The maximal daily dose of 7.5 mg was never exceeded. At 24 months, the estimated rate of patients still taking riociguat was 78.8% with an estimated mean (SD) time on treatment of 20.1 (0.5) months per patient. No new safety signals were recorded.
CONCLUSIONS
CONCLUSIONS
The results of this real-world study show that riociguat is used in France in accordance with its therapeutic indication in patients with inoperable or persistent/recurrent post-operative CTEPH and confirm its long-term safety.
Identifiants
pubmed: 36634552
pii: S2590-0412(22)00102-7
doi: 10.1016/j.resmer.2022.100987
pii:
doi:
Substances chimiques
riociguat
RU3FE2Y4XI
Types de publication
Observational Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
100987Informations de copyright
Copyright © 2022 SPLF and Elsevier Masson SAS. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of Competing Interest Lionel BENSIMON, Antoinette HAKMÉ, Nathalie BÉNARD and Laurie LEVY-BACHELOT are employees of MSD France; Mathilde POURIEL is employee of Kappa Santé; Jean DALLONGEVILLE was member of the steering committee of the present study (received honoraria and support for medical writing), within 36 months received consulting fees from MSD (steering committee) and GSK (steering committee); Bouchra LAMIA was member of the steering committee of the present study (received honoraria and support for medical writing), within 36 months received grants/contracts from Bayer, Philips Ultrasound, Vivisol and SOS oxygen, received honoraria for lectures at conferences from Chiesi, Janssen, GSK and AstraZeneca, received support for attending meetings and/or travel from AstraZeneca and Chiesi and participated to advisory board for AstraZeneca, Novartis and Chiesi; Olivier SITBON was member of the steering committee of the present study (received honoraria and support for medical writing), within 36 months benefited from grants/contracts for the institution (AP-HP) from Acceleron, Janssen, GSK and MSD, received consulting fees for participation to steering committee from Gossamer Bio, Janssen and MSD, received honoraria for lectures at conferences from AOP Orphan, Janssen, Ferrer and MSD, participated to advisory board for Acceleron, Janssen and MSD.