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

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-wor...

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Authors: 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.
Format: article
Status:Published version
Publication Date:2017
Country:España
Institution:Universidad de Barcelona
Repository:Dipòsit Digital de la UB
OAI Identifier:oai:diposit.ub.edu:2445/123223
Online Access:https://hdl.handle.net/2445/123223
Access Level:Open access
Keyword:Hipertensió pulmonar
Malalties de l'aparell respiratori
Assaigs clínics
Pulmonary hypertension
Respiratory organs diseases
Clinical trials
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spelling Riociguat in patients with chronic thromboembolic pulmonary hypertension: results from an early access studyMcLaughlin, Vallerie V.Jansa, PavelNielsen-Kudsk, Jens E.Halank, MichaelSimonneau, GéraldGrünig, EkkehardUlrich, SilviaRosenkranz, StephanGómez Sánchez, Miguel A.Pulido, TomásPepke-Zaba, JoannaBarberà i Mir, Joan AlbertHoeper, Marius MVachiéry, Jean-LucLang, IreneCarvalho, FrancineMeier, ChristianMueller, KatharinaNikkho, SylviaD'Armini, Andrea M.Hipertensió pulmonarMalalties de l'aparell respiratoriAssaigs clínicsPulmonary hypertensionRespiratory organs diseasesClinical trialsBackground: 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.Biomed Central2017info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/2445/123223Articles publicats en revistes (Medicina)reponame:Dipòsit Digital de la UBinstname:Universidad de BarcelonaInglésReproducció del document publicat a: https://doi.org/10.1186/s12890-017-0563-7BMC Pulmonary Medicine, vol. 17, p. 216https://doi.org/10.1186/s12890-017-0563-7cc-by (c) McLaughlin, Vallerie V. et al., 2017http://creativecommons.org/licenses/by/3.0/esinfo:eu-repo/semantics/openAccessoai:diposit.ub.edu:2445/1232232026-05-27T06:46:51Z
dc.title.none.fl_str_mv Riociguat in patients with chronic thromboembolic pulmonary hypertension: results from an early access study
title Riociguat in patients with chronic thromboembolic pulmonary hypertension: results from an early access study
spellingShingle Riociguat in patients with chronic thromboembolic pulmonary hypertension: results from an early access study
McLaughlin, Vallerie V.
Hipertensió pulmonar
Malalties de l'aparell respiratori
Assaigs clínics
Pulmonary hypertension
Respiratory organs diseases
Clinical trials
title_short Riociguat in patients with chronic thromboembolic pulmonary hypertension: results from an early access study
title_full Riociguat in patients with chronic thromboembolic pulmonary hypertension: results from an early access study
title_fullStr Riociguat in patients with chronic thromboembolic pulmonary hypertension: results from an early access study
title_full_unstemmed Riociguat in patients with chronic thromboembolic pulmonary hypertension: results from an early access study
title_sort Riociguat in patients with chronic thromboembolic pulmonary hypertension: results from an early access study
dc.creator.none.fl_str_mv 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.
author McLaughlin, Vallerie V.
author_facet 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.
author_role author
author2 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.
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Hipertensió pulmonar
Malalties de l'aparell respiratori
Assaigs clínics
Pulmonary hypertension
Respiratory organs diseases
Clinical trials
topic Hipertensió pulmonar
Malalties de l'aparell respiratori
Assaigs clínics
Pulmonary hypertension
Respiratory organs diseases
Clinical trials
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.
publishDate 2017
dc.date.none.fl_str_mv 2017
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/2445/123223
url https://hdl.handle.net/2445/123223
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Reproducció del document publicat a: https://doi.org/10.1186/s12890-017-0563-7
BMC Pulmonary Medicine, vol. 17, p. 216
https://doi.org/10.1186/s12890-017-0563-7
dc.rights.none.fl_str_mv cc-by (c) McLaughlin, Vallerie V. et al., 2017
http://creativecommons.org/licenses/by/3.0/es
info:eu-repo/semantics/openAccess
rights_invalid_str_mv cc-by (c) McLaughlin, Vallerie V. et al., 2017
http://creativecommons.org/licenses/by/3.0/es
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Biomed Central
publisher.none.fl_str_mv Biomed Central
dc.source.none.fl_str_mv Articles publicats en revistes (Medicina)
reponame:Dipòsit Digital de la UB
instname:Universidad de Barcelona
instname_str Universidad de Barcelona
reponame_str Dipòsit Digital de la UB
collection Dipòsit Digital de la UB
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15,301603

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