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

• Verfasst von: Simonneau, Gérald [VerfasserIn]
• Verfasst von: Ghofrani, Hossein-Ardeschir [VerfasserIn]
• Verfasst von: Corris, Paul A. [VerfasserIn]
• Verfasst von: Rosenkranz, Stephan [VerfasserIn]
• Verfasst von: Grünig, Ekkehard [VerfasserIn]
• Verfasst von: White, Jim [VerfasserIn]
• Verfasst von: McLaughlin, Vallerie V. [VerfasserIn]
• Verfasst von: Langleben, David [VerfasserIn]
• Verfasst von: Meier, Christian [VerfasserIn]
• Verfasst von: Busse, Dennis [VerfasserIn]
• Verfasst von: Kleinjung, Frank [VerfasserIn]
• Verfasst von: Benza, Raymond L. [VerfasserIn]
• Titel: Assessment of the REPLACE study composite endpoint in riociguat-treated patients in the PATENT study
• Verf.angabe: 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
• E-Jahr: 2020
• Jahr: 01 December 2020
• Umfang: 8 S.
• Illustrationen: Illustrationen
• Fussnoten: Gesehen am 26.05.2025
• Titel Quelle: Enthalten in: Pulmonary circulation
• Ort Quelle: Hoboken, NJ : Wiley, 2011
• Jahr Quelle: 2020
• Band/Heft Quelle: 10(2020), 4 vom: Dez., Seite 1-8
• ISSN Quelle: 2045-8940
• DOI: doi:10.1177/2045894020973124
• Datenträger: Online-Ressource
• Sprache: eng
• Sach-SW: clinical worsening
• Sach-SW: Pulmonary arterial hypertension
• Sach-SW: soluble guanylate cyclase (sGC) stimulator
• Sach-SW: survival
• K10plus-PPN: 1926614658

Abstract

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.