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Background And Objective: Roxadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor in phase III development for the treatment of anaemia associated with chronic kidney disease. This study evaluated the effects of moderate hepatic impairment on roxadustat pharmacokinetics, pharmacodynamics and tolerability.
Methods: This was an open-label study in which eight subjects with moderate hepatic impairment (liver cirrhosis Child-Pugh score 7-9) and eight subjects with normal hepatic function (matched for body mass index, age and sex) received a single oral 100 mg roxadustat dose under fasted conditions. Blood samples were collected until 144 h post-dose in subjects with moderate hepatic impairment and until 96 h post-dose in subjects with normal hepatic function.
Results: In subjects with moderate hepatic impairment, area under the concentration-time curve (AUC) from the time of drug administration to infinity (AUC∞) and observed maximum concentration (C max) were 23 % higher [geometric least-squares mean ratio (GMR) 123 %; 90 % CI 86.1-175] and 16 % lower (GMR 83.6 %; 90 % CI 67.5-104), respectively, than in subjects with normal hepatic function. Mean terminal half-life (t ½) appeared to be longer (17.7 vs. 12.8 h) in subjects with moderate hepatic impairment, however intersubject variability on apparent total systemic clearance after single oral dosing (CL/F), apparent volume of distribution at equilibrium after oral administration (V z/F) and t ½ was approximately twofold higher. Erythropoietin (EPO) baseline-corrected AUC from administration to the last measurable EPO concentration (AUCE,last) and maximum effect (E max) were 31 % (GMR 68.95 %; 90 % CI 29.29-162.29) and 48 % (GMR 52.29 %; 90 % CI 28.95-94.46) lower, respectively, than in subjects with normal hepatic function. The single oral roxadustat dose was generally well tolerated.
Conclusions: This study demonstrated the effect of moderate hepatic impairment on the pharmacokinetics and pharmacodynamics of roxadustat relative to subjects with normal hepatic function. These differences are not expected to be of clinical significance.
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http://dx.doi.org/10.1007/s40261-016-0422-y | DOI Listing |
J Transl Med
December 2024
Institut de Recherche Biomédicale Des Armées (IRBA), 1, Rue du Lieutenant Raoul Batany, 92141, Clamart, France.
Background: Hemorrhagic shock (HS) corresponds to absolute hypovolemia creating an imbalance between oxygen supply and consumption. This causes an impaired hemostasis, a systemic inflammatory response, and microvascular permeability which can lead to multiple organ failure (MOF). There is no specific treatment for the endothelial dysfunction that plays a major role in the evolution towards MOF.
View Article and Find Full Text PDFVopr Kurortol Fizioter Lech Fiz Kult
December 2024
Polyclinic No. 3 of the Medical Sanitary Unit of the Ministry of Internal Affairs of the Russian Federation, Moscow, Russia.
Unlabelled: Hepatic encephalopathy is an early and severe complication of obstructive jaundice and is characterized by occurrence of non-focal and focal neurological manifestations. Different methods of therapy are applied for disorder correction. Low-intensity laser blood irradiation has a pronounced antioxidant and vasoactive effect.
View Article and Find Full Text PDFEur J Nutr
December 2024
Experimental Transplantation Surgery, Department of General, Visceral and Vascular Surgery, Jena University Hospital, 07747, Jena, Germany.
Background: Excessive intake of fatty acids is a key factor contributing to metabolic dysfunction-associated steatotic liver disease (MASLD). However, the effects of saturated fatty acids (SFA) and unsaturated fatty acids (UFA) on the development of MASLD are uncertain. Therefore, we conducted two-sample Mendelian randomization studies and animal experiments to explore the effects of SFA, monounsaturated fatty acids (MUFA) and polyunsaturated fatty acids (PUFA) on the risk of developing MASLD.
View Article and Find Full Text PDFEBioMedicine
December 2024
Liver Cancer Institute, Zhongshan Hospital, and Key Laboratory of Carcinogenesis and Cancer Invasion (Ministry of Education), Fudan University, Shanghai, China. Electronic address:
Background: Liver involvement is a common complication of coronavirus disease 2019 (COVID-19), especially in hospitalized patients. However, the underlying mechanisms involved are not fully understood.
Methods: Immunohistochemistry (IHC) staining of SARS-CoV-2 spike (S) and nucleocapsid (N) proteins was conducted on liver tissues from six patients with COVID-19.
Phytochemistry
December 2024
Key Laboratory of Ethnic Medicine Resource Chemistry, Ministry of Education, Yunnan Minzu University, Kunming, 650500, Yunnan, People's Republic of China; Yunnan Key Laboratory of Chiral Functional Substance Research and Application, Yunnan Minzu University, Kunming 650504, People's Republic of China. Electronic address:
Fibraurea recisa Pierre is a vine plant and its vine stems are used as a traditional Chinese medicine to treat heat toxin, constipation, diarrhea, sore throat, eye inflammation, carbuncles, and skin ulcers. The alkaloid chemical composition of this plant has been extensively studied; however, investigations into non-alkaloid components remain limited. In this study, phytochemical studies of the vine stems of F.
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