Journal article

Publication year: 2020

Journal: Pulmonary Circulation

Volume number: 10

Issue number: 4

ISSN: 2045-8932

eISSN: 2045-8940

Open access status: Gold

DOI Link: https://doi.org/10.1177/2045894020973124

Publisher: Wiley

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-naive (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.

Harvard Citation style: Simonneau, G., Ghofrani, H., Corris, P., Rosenkranz, S., Gruenig, E., White, J., et al. (2020) Assessment of the REPLACE study composite endpoint in riociguat-treated patients in the PATENT study, Pulmonary Circulation, 10(4), Article 2045894020973124. https://doi.org/10.1177/2045894020973124

APA Citation style: Simonneau, G., Ghofrani, H., Corris, P., Rosenkranz, S., Gruenig, E., White, J., McLaughlin, V., Langleben, D., Meier, C., Busse, D., Kleinjung, F., & Benza, R. (2020). Assessment of the REPLACE study composite endpoint in riociguat-treated patients in the PATENT study. Pulmonary Circulation. 10(4), Article 2045894020973124. https://doi.org/10.1177/2045894020973124