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dc.contributor.author | McLaughlin, Vallerie V. |
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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 |