Universität zu Köln

Ghofrani, Hossein-Ardeschir, Gruenig, Ekkehard, Jansa, Pavel ORCID: 0000-0002-3711-7064, Langleben, David, Rosenkranz, Stephan, Preston, Ioana R., Rahaghi, Franck, Sood, Namita, Busse, Dennis, Meier, Christian and Humbert, Marc (2020). Efficacy and safety of riociguat in combination therapy for patients with pulmonary arterial hypertension (PATENT studies). Pulm. Circ., 10 (3). THOUSAND OAKS: SAGE PUBLICATIONS INC. ISSN 2045-8940

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Abstract

Many patients with pulmonary arterial hypertension do not achieve treatment goals with monotherapy, and therefore combination therapy is becoming the standard of care. The soluble guanylate cyclase stimulator riociguat is licensed for the treatment of pulmonary arterial hypertension; here we present findings from patients who were receiving combined riociguat plus endothelin receptor antagonists or non-intravenous prostanoids in the randomized, placebo-controlled PATENT-1 study and its open-label extension (PATENT-2). Moreover, we include new data from patients receiving early sequential combination therapy (three to six months of endothelin receptor antagonist treatment) or long-term background endothelin receptor antagonist therapy (>6 months). Patients were randomized to riociguat 2.5 mg-maximum (N = 131 pretreated patients) and placebo (N = 60 pretreated patients). Riociguat improved 6-min walking distance (PATENT-1 primary endpoint), functional capacity, and hemodynamics after 12 weeks in pretreated patients. The placebo-corrected changes in 6-min walking distance were +24 m in endothelin receptor antagonist-pretreated patients and +106 m in the small group of prostanoid-pretreated patients. In the early sequential combination and long-term background endothelin receptor antagonist groups, the placebo-corrected changes in 6-min walking distance were +65 m (95% CI: 17 to 113 m) and +13 m (95% CI: -8 to 33 m), respectively. In conclusion, these data suggest that early sequential combination of an endothelin receptor antagonist plus riociguat is a feasible treatment option. Both early sequential therapy and long-term background endothelin receptor antagonist plus riociguat were well tolerated in the PATENT studies.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Ghofrani, Hossein-Ardeschir UNSPECIFIED UNSPECIFIED UNSPECIFIED Gruenig, Ekkehard UNSPECIFIED UNSPECIFIED UNSPECIFIED Jansa, Pavel UNSPECIFIED orcid.org/0000-0002-3711-7064 UNSPECIFIED Langleben, David UNSPECIFIED UNSPECIFIED UNSPECIFIED Rosenkranz, Stephan UNSPECIFIED UNSPECIFIED UNSPECIFIED Preston, Ioana R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Rahaghi, Franck UNSPECIFIED UNSPECIFIED UNSPECIFIED Sood, Namita UNSPECIFIED UNSPECIFIED UNSPECIFIED Busse, Dennis UNSPECIFIED UNSPECIFIED UNSPECIFIED Meier, Christian UNSPECIFIED UNSPECIFIED UNSPECIFIED Humbert, Marc UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-327622
DOI:	10.1177/2045894020942121
Journal or Publication Title:	Pulm. Circ.
Volume:	10
Number:	3
Date:	2020
Publisher:	SAGE PUBLICATIONS INC
Place of Publication:	THOUSAND OAKS
ISSN:	2045-8940
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language LONG-TERM EXTENSION; SURVIVAL Multiple languages Cardiac & Cardiovascular Systems; Respiratory System Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/32762