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

• Published in: Pulmonary circulation 2020-10, Vol.10 (4), p.1-8
• Main Authors: Simonneau, Gérald, Ghofrani, Hossein-Ardeschir, Corris, Paul A., Rosenkranz, Stephan, Grünig, Ekkehard, White, Jim, McLaughlin, Vallerie V., Langleben, David, Meier, Christian, Busse, Dennis, Kleinjung, Frank, Benza, Raymond L.
• Format: Article
• Language: English
• Subjects: clinical worsening; Life Sciences; Original; Pulmonary arterial hypertension; Pulmonary hypertension; soluble guanylate cyclase (sGC) stimulator; survival
• ISSN: 2045-8940; 2045-8932; 2045-8940
• DOI: 10.1177/2045894020973124

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