Comparison of hemodynamic parameters in treatment-naïve and pre-treated patients with pulmonary arterial hypertension in the randomized phase III PATENT-1 study

• Verfasst von: Galiè, Nazzareno [VerfasserIn]
• Verfasst von: Grünig, Ekkehard [VerfasserIn]
• Titel: Comparison of hemodynamic parameters in treatment-naïve and pre-treated patients with pulmonary arterial hypertension in the randomized phase III PATENT-1 study
• Verf.angabe: Nazzareno Galiè, Friedrich Grimminger, Ekkehard Grünig, Marius M. Hoeper, Marc Humbert, Zhi-Cheng Jing, Anne M. Keogh, David Langleben, Lewis J. Rubin, Arno Fritsch, Neil Davie, and Hossein-Ardeschir Ghofrani
• Umfang: 11 S.
• Fussnoten: Available online 24 December 2016 ; Gesehen am 05.06.2018
• Titel Quelle: Enthalten in: The journal of heart and lung transplantation
• Jahr Quelle: 2017
• Band/Heft Quelle: 36(2017), 5, S. 509-519
• ISSN Quelle: 1557-3117
• DOI: doi:10.1016/j.healun.2016.12.012
• Datenträger: Online-Ressource
• Sprache: eng
• K10plus-PPN: 1575995417

Abstract

Background: Detailed hemodynamic data from the phase III PATENT-1 study of riociguat in patients with pulmonary arterial hypertension (PAH) were investigated. Methods: Patients with PAH who were treatment naïve 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-naïve (n = 221; least squares [LS] mean difference −266 dyne∙sec∙cm−5 [95% confidence interval (CI) −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 fortreatment-naïve 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-naïve patients with PAH.