McLaughlin, Vallerie V., Jansa, Pavel ORCID: 0000-0002-3711-7064, Nielsen-Kudsk, Jens E., Halank, Michael, Simonneau, Gerald, Gruenig, Ekkehard, Ulrich, Silvia ORCID: 0000-0002-5250-5022, Rosenkranz, Stephan, Gomez Sanchez, Miguel A., Pulido, Tomas, Pepke-Zaba, Joanna, Albert Barbera, Joan, Hoeper, Marius M., Vachiery, Jean-Luc, Lang, Irene, Carvalho, Francine, Meier, Christian, Mueller, Katharina, Nikkho, Sylvia and D'Armini, Andrea M. (2017). Riociguat in patients with chronic thromboembolic pulmonary hypertension: results from an early access study. BMC Pulm. Med., 17. LONDON: BMC. ISSN 1471-2466

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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 naive. 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-naive subgroups. Conclusions: Riociguat was well tolerated in patients with CTEPH who were treatment naive, and in those who were switched from other PAH-targeted therapies. No new safety signals were observed.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
McLaughlin, Vallerie V.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Jansa, PavelUNSPECIFIEDorcid.org/0000-0002-3711-7064UNSPECIFIED
Nielsen-Kudsk, Jens E.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Halank, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Simonneau, GeraldUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gruenig, EkkehardUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ulrich, SilviaUNSPECIFIEDorcid.org/0000-0002-5250-5022UNSPECIFIED
Rosenkranz, StephanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gomez Sanchez, Miguel A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pulido, TomasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pepke-Zaba, JoannaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Albert Barbera, JoanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hoeper, Marius M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vachiery, Jean-LucUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lang, IreneUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Carvalho, FrancineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Meier, ChristianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mueller, KatharinaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Nikkho, SylviaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
D'Armini, Andrea M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-207641
DOI: 10.1186/s12890-017-0563-7
Journal or Publication Title: BMC Pulm. Med.
Volume: 17
Date: 2017
Publisher: BMC
Place of Publication: LONDON
ISSN: 1471-2466
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
LONG-TERM EXTENSION; ENDARTERECTOMY; OUTCOMESMultiple languages
Respiratory SystemMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/20764

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