Abstract
BackgroundTolvaptan has been approved in Japan for the treatment of hepatic edema. An important consideration in providing a clinical benefit to patients with liver cirrhosis is the improvement of ascites-related clinical symptoms. In the present post hoc analysis, we aimed to identify factors that were predictive of the potency of tolvaptan, and to examine the relationship between changes in initial urine volume and improvement in ascites-related clinical symptoms.MethodsThis post hoc analysis was based on three previous phase 2 and 3 clinical trials of tolvaptan in patients with liver cirrhosis. Predictive factors associated with a change in initial urine volume were identified. A change of ≥500 mL from baseline confirmed the pharmacological action of tolvaptan treatment. The relationship between the change in initial urine volume and improvement in ascites-related clinical symptoms was also examined.ResultsA total of 152 patients were enrolled in this study. Body weight and BUN were identified as predictive parameters. Among patients with a change in initial urine volume of ≥500 mL, 75 % demonstrated improvement in ascites-related clinical symptoms, while no improvement was seen in those with a change of <500 mL. None of the patients with initial urine volume of <500 mL showed resolution of symptoms.ConclusionsChange in urine volume was affected by both baseline body weight and BUN in tolvaptan-treated subjects. Higher urine output was associated with improvements in ascites-related clinical symptoms.
Highlights
The development of ascites is a major complication in patients with liver cirrhosis, associated with reduced quality of life and decreased survival [1]
The objectives of the present post hoc analysis in patients with ascites who received the trial drug were to identify baseline parameters that could be used to predict the pharmacological action of tolvaptan, to evaluate changes in ascites-related clinical symptoms from baseline to day 7 based on changes in initial urine volume of C500 or \500 mL, and to evaluate changes in body weight and serum sodium level from baseline to day 1 based on urine volume stratification
The cutoff points for body weight and blood urease nitrogen (BUN) were 59.4 kg and 25.2 mg/dL, and area under the curve (AUC) were 0.66 and 0.69, in graphical display of the Receiver operating characteristic (ROC) curves, respectively
Summary
The development of ascites is a major complication in patients with liver cirrhosis, associated with reduced quality of life and decreased survival [1]. Most patients are properly managed with diuretic treatment as a therapeutic option for controlling ascites. Among these agents, furosemide is useful for improving hypervolemic status, but is commonly associated with electrolyte imbalance, progressive renal failure, and worsening hepatic encephalopathy [4,5,6,7,8]. Furosemide is useful for improving hypervolemic status, but is commonly associated with electrolyte imbalance, progressive renal failure, and worsening hepatic encephalopathy [4,5,6,7,8] Evidence regarding both the advantages and disadvantages of conventional diuretics have been described in detail in the guidelines. In the present post hoc analysis, we aimed to identify factors that were predictive of the potency of tolvaptan, and to examine the relationship between changes in initial urine volume and improvement in ascites-related clinical symptoms
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
