Assessment of the REPLACE study composite endpoint in riociguat-treated patients in the PATENT study.

The goal of treatment in patients with pulmonary arterial hypertension is to achieve a low risk status, indicating a favorable long-term outcome. The REPLACE study investigated the efficacy of switching to riociguat in patients with pulmonary arterial hypertension and an insufficient response to phosphodiesterase-5 inhibitors. In this post hoc analysis, we applied the REPLACE composite endpoint of clinical improvement to the placebo-controlled PATENT-1 study of riociguat in pulmonary arterial hypertension and its long-term extension, PATENT-2. Clinical improvement was defined as ≥2 of the following in patients who completed the study without clinical worsening: ≥10% or ≥30 m improvement in 6-minute walking distance; World Health Organization functional class I or II; ≥30% decrease in

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Déclaration de conflit d'intérêts

Declaration of conflicting interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: GS reports grants, personal fees, and non-financial support from Actelion, Bayer, GSK, and Merck. H-AG reports non-financial support, grants, and personal fees from Actelion; grants and personal fees from Bayer, Novartis Corporation, and Pfizer; and personal fees from Gilead Sciences, GSK, and Merck. PAC reports grants and personal fees from Actelion and Bayer, and personal fees from MSD. SR reports remunerations for lectures and/or consultancy from Abbott, Actelion, Arena, Bayer, Ferrer, GSK, MSD, Novartis, Pfizer, and United Therapeutics, and research support from Actelion, Bayer, Novartis, Pfizer, and United Therapeutics. EG reports grants and personal fees from Actelion and Bayer/MSD; grants from GSK, Novartis, and United Therapeutics, and personal fees from OrPha Swiss GmbH, SCOPE, and Zurich Heart House. JW reports no conflicts of interest. VVM reports grants, personal fees, and non-financial support from Actelion and Bayer; grants from Eiger and SoniVie; and personal fees from Arena, Caremark, Medtronic, MSD, and United Therapeutics. DL reports grants, personal fees, and non-financial support from Actelion and Bayer, personal fees from Merck and United Therapeutics; and grants from Northern Therapeutics. CM and FK are employees of Bayer AG. DB was an employee of Chrestos Concept GmbH & Co., KG, Essen, Germany at the time of the study and manuscript development. RLB reports grants from Actelion, Bayer AG, Eiger, Gilead, and United Therapeutics paid to his institution, and honoraria from Actelion, Bayer AG and Gilead.