Predicting Response to Switching From Phosphodiesterase Type 5 Inhibitor to Riociguat in Patients With Pulmonary Arterial Hypertension: Biomarker and Responder Analysis of the RESPITE and REPLACE Studies

James R Klinger; Hikmet Al-Hiti; Sung-A Chang; Hyuk J Chang; Hossein-Ardeschir Ghofrani; Ekkehard Grünig; Marius M Hoeper; Pavel Jansa; Jaquelina Ota-Arakaki; Tomas Pulido; Gérald Simonneau; Carmine Dario Vizza; Claudia Rahner; Christian Meier; Gisela Meyer

doi:This exploratory analysis assessed whether plasma biomarkers predict the response to switching from phosphodiesterase type 5 inhibitors (PDE5is) to the soluble guanylate cyclase stimulator riociguat in patients with pulmonary arterial hypertension. Selected biomarkers at baseline and their changes to Week 24 were evaluated in patients with and without a favorable response to riociguat in two trials: RESPITE, in which patients with an inadequate response to PDE5i were switched to riociguat; and REPLACE, in which patients at intermediate risk of 1-year mortality despite a PDE5i were randomized to remain on PDE5i or were switched to riociguat. A response was defined as absence of clinical worsening and at least two of the following criteria: 6-min walk distance increase by 10% or ≥ 30 m, World Health Organization functional class I/II, or N-terminal prohormone of brain natriuretic peptide reduction of ≥ 30% at Week 24. In REPLACE, responders had significantly higher baseline cyclic guanosine monophosphate (cGMP) and significantly lower baseline asymmetric dimethylarginine, and growth/differentiation factor 15 (GDF-15) than nonresponders. In RESPITE, responders had lower baseline GDF-15 than nonresponders, and nonresponders showed a significantly greater decrease in cGMP than responders. No baseline threshold value of any biomarker provided a good likelihood of predicting the response to riociguat. Overall, the biomarkers evaluated did not help to identify patients who were more likely to respond to switching from PDE5is to riociguat.

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Predicting Response to Switching From Phosphodiesterase Type 5 Inhibitor to Riociguat in Patients With Pulmonary Arterial Hypertension: Biomarker and Responder Analysis of the RESPITE and REPLACE Studies

DC Field	Value	Language
dc.contributor.author	장혁재	-
dc.date.accessioned	2025-10-15T02:00:04Z	-
dc.date.available	2025-10-15T02:00:04Z	-
dc.date.issued	2025-08	-
dc.identifier.issn	2045-8932	-
dc.identifier.uri	https://ir.ymlib.yonsei.ac.kr/handle/22282913/207539	-
dc.description.abstract	risk assessment ; soluble guanylate cyclase stimulators ; treatment guidelines	-
dc.description.statementOfResponsibility	T202506256.pdf	-
dc.language	English	-
dc.publisher	Wiley	-
dc.relation.isPartOf	PULMONARY CIRCULATION(Pulmonary circulation)	-
dc.rights	CC BY-NC-ND 2.0 KR	-
dc.subject.MESH	0	-
dc.title	Predicting Response to Switching From Phosphodiesterase Type 5 Inhibitor to Riociguat in Patients With Pulmonary Arterial Hypertension: Biomarker and Responder Analysis of the RESPITE and REPLACE Studies	-
dc.type	Article	-
dc.contributor.college	College of Medicine (의과대학)	-
dc.contributor.department	Dept. of Internal Medicine (내과학교실)	-
dc.contributor.googleauthor	James R Klinger	-
dc.contributor.googleauthor	Hikmet Al-Hiti	-
dc.contributor.googleauthor	Sung-A Chang	-
dc.contributor.googleauthor	Hyuk J Chang	-
dc.contributor.googleauthor	Hossein-Ardeschir Ghofrani	-
dc.contributor.googleauthor	Ekkehard Grünig	-
dc.contributor.googleauthor	Marius M Hoeper	-
dc.contributor.googleauthor	Pavel Jansa	-
dc.contributor.googleauthor	Jaquelina Ota-Arakaki	-
dc.contributor.googleauthor	Tomas Pulido	-
dc.contributor.googleauthor	Gérald Simonneau	-
dc.contributor.googleauthor	Carmine Dario Vizza	-
dc.contributor.googleauthor	Claudia Rahner	-
dc.contributor.googleauthor	Christian Meier	-
dc.contributor.googleauthor	Gisela Meyer	-
dc.identifier.doi	This exploratory analysis assessed whether plasma biomarkers predict the response to switching from phosphodiesterase type 5 inhibitors (PDE5is) to the soluble guanylate cyclase stimulator riociguat in patients with pulmonary arterial hypertension. Selected biomarkers at baseline and their changes to Week 24 were evaluated in patients with and without a favorable response to riociguat in two trials: RESPITE, in which patients with an inadequate response to PDE5i were switched to riociguat; and REPLACE, in which patients at intermediate risk of 1-year mortality despite a PDE5i were randomized to remain on PDE5i or were switched to riociguat. A response was defined as absence of clinical worsening and at least two of the following criteria: 6-min walk distance increase by 10% or ≥ 30 m, World Health Organization functional class I/II, or N-terminal prohormone of brain natriuretic peptide reduction of ≥ 30% at Week 24. In REPLACE, responders had significantly higher baseline cyclic guanosine monophosphate (cGMP) and significantly lower baseline asymmetric dimethylarginine, and growth/differentiation factor 15 (GDF-15) than nonresponders. In RESPITE, responders had lower baseline GDF-15 than nonresponders, and nonresponders showed a significantly greater decrease in cGMP than responders. No baseline threshold value of any biomarker provided a good likelihood of predicting the response to riociguat. Overall, the biomarkers evaluated did not help to identify patients who were more likely to respond to switching from PDE5is to riociguat.	-
dc.contributor.localId	A03490	-
dc.relation.journalcode	J04773	-
dc.identifier.eissn	2045-8940	-
dc.identifier.pmid	40821859	-
dc.contributor.alternativeName	Chang, Hyuck Jae	-
dc.contributor.affiliatedAuthor	장혁재	-
dc.citation.volume	15	-
dc.citation.number	3	-
dc.citation.startPage	e70140	-
dc.identifier.bibliographicCitation	PULMONARY CIRCULATION, Vol.15(3) : e70140, 2025-08	-
dc.identifier.articleno	10.1002/pul2.70140	-

Appears in Collections:: 1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

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