Hoeper, Marius M., Simonneau, Gerald, Corris, Paul A., Ghofrani, Hossein-Ardeschir, Klinger, James R., Langleben, David, Naeije, Robert, Jansa, Pavel ORCID: 0000-0002-3711-7064, Rosenkranz, Stephan, Scelsi, Laura ORCID: 0000-0001-9409-691X, Gruenig, Ekkehard, Vizza, Carmine Dario, Chang, MiKyung, Colorado, Pablo, Meier, Christian, Busse, Dennis and Benza, Raymond L. (2017). RESPITE: switching to riociguat in pulmonary arterial hypertension patients with inadequate response to phosphodiesterase-5 inhibitors. Eur. Resp. J., 50 (3). SHEFFIELD: EUROPEAN RESPIRATORY SOC JOURNALS LTD. ISSN 1399-3003

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Abstract

A proportion of pulmonary arterial hypertension (PAH) patients do not reach treatment goals with phosphodiesterase-5 inhibitors (PDE5i). RESPITE investigated the safety, feasibility and benefit of switching from PDE5i to riociguat in these patients. RESPITE was a 24-week, open-label, multicentre, uncontrolled study. Patients in World Health Organization (WHO) functional class (FC) III, with 6-min walking distance (6MWD) 165-440 m, cardiac index < 3.0 L min-1 m-2 and pulmonary vascular resistance > 400 dyn s cm-5 underwent a 1-3 day PDE5i treatmentfree period before receiving riociguat adjusted up to 2.5 mg maximum t. i. d. Exploratory end-points included change in 6MWD, WHO FC, N-terminal prohormone of brain natriuretic peptide (NT-proBNP) and safety. Of 61 patients enrolled, 51 (84%) completed RESPITE. 50 (82%) were receiving concomitant endothelin receptor antagonists. At week 24, mean +/- SD 6MWD had increased by 31 +/- 63 m, NT-proBNP decreased by 347 +/- 1235 pg mL-1 and WHO FC improved in 28 patients (54%). 32 patients (52%) experienced study drug-related adverse events and 10 (16%) experienced serious adverse events (2 (3%) study drug-related, none during the PDE5i treatment-free period). Six patients (10%) experienced clinical worsening, including death in two (not study drug-related). In conclusion, selected patients with PAH may benefit from switching from PDE5i to riociguat, but this strategy needs to be further studied.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Hoeper, Marius M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Simonneau, GeraldUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Corris, Paul A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ghofrani, Hossein-ArdeschirUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Klinger, James R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Langleben, DavidUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Naeije, RobertUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Jansa, PavelUNSPECIFIEDorcid.org/0000-0002-3711-7064UNSPECIFIED
Rosenkranz, StephanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Scelsi, LauraUNSPECIFIEDorcid.org/0000-0001-9409-691XUNSPECIFIED
Gruenig, EkkehardUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vizza, Carmine DarioUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Chang, MiKyungUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Colorado, PabloUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Meier, ChristianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Busse, DennisUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Benza, Raymond L.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-220691
DOI: 10.1183/13993003.02425-2016
Journal or Publication Title: Eur. Resp. J.
Volume: 50
Number: 3
Date: 2017
Publisher: EUROPEAN RESPIRATORY SOC JOURNALS LTD
Place of Publication: SHEFFIELD
ISSN: 1399-3003
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
SOLUBLE GUANYLATE-CYCLASE; NITRIC-OXIDE; IMPORTANT DIFFERENCE; SILDENAFIL; THERAPY; SURVIVAL; REGISTRY; PATHOBIOLOGY; TADALAFIL; BOSENTANMultiple languages
Respiratory SystemMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/22069

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