Riociguat in patients with chronic thromboembolic pulmonary hypertension: results from an early access study

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RECERCAT Home > Universitat de Barcelona > IDIBAPS: Institut d'investigacions Biomèdiques August Pi i Sunyer > Articles publicats en revistes (IDIBAPS: Institut d'investigacions Biomèdiques August Pi i Sunyer) > View document

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dc.contributor.author	McLaughlin, Vallerie V.
dc.contributor.author	Jansa, Pavel
dc.contributor.author	Nielsen-Kudsk, Jens E.
dc.contributor.author	Halank, Michael
dc.contributor.author	Simonneau, Gérald
dc.contributor.author	Grünig, Ekkehard
dc.contributor.author	Ulrich, Silvia
dc.contributor.author	Rosenkranz, Stephan
dc.contributor.author	Gómez Sánchez, Miguel A.
dc.contributor.author	Pulido, Tomás
dc.contributor.author	Pepke-Zaba, Joanna
dc.contributor.author	Barberà i Mir, Joan Albert
dc.contributor.author	Hoeper, Marius M
dc.contributor.author	Vachiéry, Jean-Luc
dc.contributor.author	Lang, Irene
dc.contributor.author	Carvalho, Francine
dc.contributor.author	Meier, Christian
dc.contributor.author	Mueller, Katharina
dc.contributor.author	Nikkho, Sylvia
dc.contributor.author	D'Armini, Andrea M.
dc.date	2018-06-25T11:12:09Z
dc.date	2018-06-25T11:12:09Z
dc.date	2017-12-28
dc.date	2018-06-25T11:12:09Z
dc.identifier	1932-6203
dc.identifier	678528
dc.identifier	29282032
dc.identifier.uri	http://hdl.handle.net/2445/123223
dc.description	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.
dc.format	9 p.
dc.format	application/pdf
dc.language	eng
dc.publisher	Biomed Central
dc.relation	Reproducció del document publicat a: https://doi.org/10.1186/s12890-017-0563-7
dc.relation	BMC Pulmonary Medicine, vol. 17, p. 216
dc.relation	https://doi.org/10.1186/s12890-017-0563-7
dc.rights	cc-by (c) McLaughlin, Vallerie V. et al., 2017
dc.rights	http://creativecommons.org/licenses/by/3.0/es
dc.rights	info:eu-repo/semantics/openAccess
dc.subject	Hipertensió pulmonar
dc.subject	Malalties de l'aparell respiratori
dc.subject	Assaigs clínics
dc.subject	Pulmonary hypertension
dc.subject	Respiratory organs diseases
dc.subject	Clinical trials
dc.title	Riociguat in patients with chronic thromboembolic pulmonary hypertension: results from an early access study
dc.type	info:eu-repo/semantics/article
dc.type	info:eu-repo/semantics/publishedVersion

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