Please use this identifier to cite or link to this item:
http://hdl.handle.net/2445/123223
Title: | Riociguat in patients with chronic thromboembolic pulmonary hypertension: results from an early access study |
Author: | McLaughlin, Vallerie V. Jansa, Pavel Nielsen-Kudsk, Jens E. Halank, Michael Simonneau, Gérald Grünig, Ekkehard Ulrich, Silvia Rosenkranz, Stephan Gómez Sánchez, Miguel A. Pulido, Tomás Pepke-Zaba, Joanna Barberà i Mir, Joan Albert Hoeper, Marius M Vachiéry, Jean-Luc Lang, Irene Carvalho, Francine Meier, Christian Mueller, Katharina Nikkho, Sylvia D'Armini, Andrea M. |
Keywords: | Hipertensió pulmonar Malalties de l'aparell respiratori Assaigs clínics Pulmonary hypertension Respiratory organs diseases Clinical trials |
Issue Date: | 28-Dec-2017 |
Publisher: | Biomed Central |
Abstract: | Background: Following positive results from the Phase III CHEST-1 study in patients with inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH), the Phase IIIb CTEPH early access study (EAS) was designed to assess the safety and tolerability of riociguat in real-world clinical practice, as well as to provide patients with early access to riociguat before launch. Riociguat is approved for the treatment of inoperable and persistent/recurrent CTEPH. Methods: We performed an open-label, uncontrolled, single-arm, early access study in which 300 adult patients with inoperable or persistent/recurrent CTEPH received riociguat adjusted from 1 mg three times daily (tid) to a maximum of 2.5 mg tid. Patients switching from unsatisfactory prior pulmonary arterial hypertension (PAH)-targeted therapy (n = 84) underwent a washout period of at least 3 days before initiating riociguat. The primary aim was to assess the safety and tolerability of riociguat, with World Health Organization functional class and 6-min walking distance (6MWD) as exploratory efficacy endpoints. Results: In total, 262 patients (87%) completed study treatment and entered the safety follow-up (median treatment duration 47 weeks). Adverse events were reported in 273 patients (91%). The most frequently reported serious adverse events were syncope (6%), right ventricular failure (3%), and pneumonia (2%). There were five deaths, none of which was considered related to study medication. The safety and tolerability of riociguat was similar in patients switched from other PAH-targeted therapies and those who were treatment naïve. In patients with data available, mean ± standard deviation 6MWD had increased by 33 ± 42 m at Week 12 with no clinically relevant differences between the switched and treatment-naïve subgroups. Conclusions: Riociguat was well tolerated in patients with CTEPH who were treatment naïve, and in those who were switched from other PAH-targeted therapies. No new safety signals were observed. |
Note: | Reproducció del document publicat a: https://doi.org/10.1186/s12890-017-0563-7 |
It is part of: | BMC Pulmonary Medicine, vol. 17, p. 216 |
URI: | http://hdl.handle.net/2445/123223 |
Related resource: | https://doi.org/10.1186/s12890-017-0563-7 |
ISSN: | 1932-6203 |
Appears in Collections: | Articles publicats en revistes (IDIBAPS: Institut d'investigacions Biomèdiques August Pi i Sunyer) Articles publicats en revistes (Medicina) |
Files in This Item:
File | Description | Size | Format | |
---|---|---|---|---|
678528.pdf | 487.25 kB | Adobe PDF | View/Open |
This item is licensed under a Creative Commons License