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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
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, Crhistian
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:
It is part of: BMC Pulmonary Medicine, vol. 17, p. 216
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ISSN: 1932-6203
Appears in Collections:Articles publicats en revistes (IDIBAPS: Institut d'investigacions Biomèdiques August Pi i Sunyer)
Articles publicats en revistes (Medicina)

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