Universität zu Köln

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:	Creators Email ORCID ORCID Put Code McLaughlin, Vallerie V. UNSPECIFIED UNSPECIFIED UNSPECIFIED Jansa, Pavel UNSPECIFIED orcid.org/0000-0002-3711-7064 UNSPECIFIED Nielsen-Kudsk, Jens E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Halank, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Simonneau, Gerald UNSPECIFIED UNSPECIFIED UNSPECIFIED Gruenig, Ekkehard UNSPECIFIED UNSPECIFIED UNSPECIFIED Ulrich, Silvia UNSPECIFIED orcid.org/0000-0002-5250-5022 UNSPECIFIED Rosenkranz, Stephan UNSPECIFIED UNSPECIFIED UNSPECIFIED Gomez Sanchez, Miguel A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Pulido, Tomas UNSPECIFIED UNSPECIFIED UNSPECIFIED Pepke-Zaba, Joanna UNSPECIFIED UNSPECIFIED UNSPECIFIED Albert Barbera, Joan UNSPECIFIED UNSPECIFIED UNSPECIFIED Hoeper, Marius M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Vachiery, Jean-Luc UNSPECIFIED UNSPECIFIED UNSPECIFIED Lang, Irene UNSPECIFIED UNSPECIFIED UNSPECIFIED Carvalho, Francine UNSPECIFIED UNSPECIFIED UNSPECIFIED Meier, Christian UNSPECIFIED UNSPECIFIED UNSPECIFIED Mueller, Katharina UNSPECIFIED UNSPECIFIED UNSPECIFIED Nikkho, Sylvia UNSPECIFIED UNSPECIFIED UNSPECIFIED D'Armini, Andrea M. UNSPECIFIED UNSPECIFIED UNSPECIFIED
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:	Keywords Language LONG-TERM EXTENSION; ENDARTERECTOMY; OUTCOMES Multiple languages Respiratory System Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/20764