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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 pho...

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Main Authors: Simonneau, Gérald (Author) , Ghofrani, Hossein-Ardeschir (Author) , Corris, Paul A. (Author) , Rosenkranz, Stephan (Author) , Grünig, Ekkehard (Author) , White, Jim (Author) , McLaughlin, Vallerie V. (Author) , Langleben, David (Author) , Meier, Christian (Author) , Busse, Dennis (Author) , Kleinjung, Frank (Author) , Benza, Raymond L. (Author)
Format: Article (Journal)
Language:English
Published: 01 December 2020
In: Pulmonary circulation
Year: 2020, Volume: 10, Issue: 4, Pages: 1-8
ISSN:2045-8940
DOI:10.1177/2045894020973124
Online Access:Verlag, kostenfrei, Volltext: https://doi.org/10.1177/2045894020973124
Verlag, kostenfrei, Volltext: https://onlinelibrary.wiley.com/doi/abs/10.1177/2045894020973124
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Author Notes:Gérald Simonneau, Hossein-Ardeschir Ghofrani, Paul A. Corris, Stephan Rosenkranz, Ekkehard Grünig, Jim White, Vallerie V. McLaughlin, David Langleben, Christian Meier, Dennis Busse, Frank Kleinjung and Raymond L. Benza
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Summary: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 N-terminal prohormone of brain natriuretic peptide. At PATENT-1 Week 12, patients treated with riociguat were more likely to achieve the composite endpoint vs. placebo (P < 0.0001), with similar results in pretreated (P = 0.0189) and treatment-naïve (P < 0.0001) patients. Achievement of the composite endpoint at Week 12 was associated with a 45% reduction in relative risk of death and a 19% reduction in relative risk of clinical worsening in PATENT-2. Overall, these data suggest that use of the REPLACE composite endpoint in patients with pulmonary arterial hypertension is a valid assessment of response to treatment.
Item Description:Gesehen am 26.05.2025
Physical Description:Online Resource
ISSN:2045-8940
DOI:10.1177/2045894020973124

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