Journal article

Publication year: 2017

Pages: 509-519

Journal: The Journal of Heart and Lung Transplantation

Volume number: 36

Issue number: 5

ISSN: 1053-2498

eISSN: 1557-3117

Open access status: Hybrid

DOI Link: https://doi.org/10.1016/j.healun.2016.12.012

Publisher: Elsevier

Abstract: 

BACKGROUND: Detailed hemodynamic data from the phase III PATENT-I study of riociguat in patients with pulmonary arterial hypertension (PAH) were investigated.

METHODS: Patients with PAH who were treatment naive or pre-treated with endothelin receptor antagonists or non-intravenous prostanoids were randomly assigned to riociguat up to 2.5 mg(-3) times a day or placebo. Hemodynamic parameters were assessed at baseline and week 12.

RESULTS: Riociguat significantly decreased pulmonary vascular resistance in treatment-nave (n = 221; least squares [LS] mean difference 266 dyne.sec.cm(-5) [95% confidence interval (Cl) -357 to -175; p < 0.0001]) and pre-treated (n = 222; LS mean difference -186 dyne.sec.cm(-5) [95% CI -252 to -120; p < 0.0001]) patients and significantly increased cardiac index (LS mean difference +0.7 [95% CI 0.5 to 0.8] and +0.5 [95% CI 0.3 to 0.7], respectively [both p < 0.0001]). Mean pulmonary artery pressure (p = 0.0056 and p = 0.0019 for treatment-naive and pre-treated patients, respectively), mean arterial pressure (both p < 0.0001), and systemic vascular resistance (both p < 0.0001) were significantly reduced, and there was an increase in mixed venous oxygen saturation (p < 0.0001 and p = 0.0004, respectively). Results were similar in patients pre-treated with endothelin receptor antagonists and patients pre-treated with non-intravenous prostanoids. Improvements in 6-minute walking distance correlated very weakly with improvements in pulmonary vascular resistance (r = -0.21 [95% CI -0.30 to -0.11; p < 0.0001]) and cardiac index (r = 0.16 [95% CI 0.06 to 0.25; p < 0.0016]).

CONCLUSIONS: Riociguat significantly improved hemodynamic parameters in pre-treated and treatment-naive patients with PAH. (C) 2017 The Authors. Published by Elsevier Inc.

Harvard Citation style: Gabe, N., Grimminger, F., Gruenig, E., Hoeper, M., Humbert, M., Jing, Z., et al. (2017) Comparison of hemodynamic parameters in treatment-naive and pre-treated patients with pulmonary arterial hypertension in the randomized phase III PATENT-1 study, The Journal of Heart and Lung Transplantation, 36(5), pp. 509-519. https://doi.org/10.1016/j.healun.2016.12.012

APA Citation style: Gabe, N., Grimminger, F., Gruenig, E., Hoeper, M., Humbert, M., Jing, Z., Keogh, A., Langleben, D., Rubin, L., Fritsch, A., Davie, N., & Ghofrani, H. (2017). Comparison of hemodynamic parameters in treatment-naive and pre-treated patients with pulmonary arterial hypertension in the randomized phase III PATENT-1 study. The Journal of Heart and Lung Transplantation. 36(5), 509-519. https://doi.org/10.1016/j.healun.2016.12.012