Please use this identifier to cite or link to this item:
http://repo.knmu.edu.ua/handle/123456789/7763
Title: | Randomized, double-blind, controlled study of glycerol phenylbutyrate in hepatic encephalopathy |
Authors: | Rockey, Don Vierling, John Mantry, Parvez Ghabril, Marwan Brown, Robert Alexeeva, Olga Zupanets, Igor Grinevich, Vladimir Baranovsky, Andrey Dudar, Larysa Fadieienko, Galyna Kharchenko, Nataliya Klaryts’ka, Iryna Morozov, Vyacheslav Grewal, Priya McCashland, Timothy Reddy, Gautham Reddy, Rajender Syplyviy, Vasyl Bass, Nathan Dickinson, Klara Norris, Catherine Coakley, Dion Mokhtarani, Masoud Scharschmidt, Bruce |
Keywords: | liver diseases encefalopathy clinical trials glycerol phenylbutyrate |
Issue Date: | Mar-2014 |
Citation: | Randomized, double-blind, controlled study of glycerol phenylbutyrate in hepatic encephalopathy / D. Rockey, J. Vierling, P. Mantry, M. Ghabril, R. S. Brown, O. Alexeeva, I. A. Zupanets, V. Grinevich, A. Baranovsky, L. Dudar, G. Fadieienko, N. Kharchenko, I. Klaryts’ka, V. Morozov, P. Grewal, T. McCashland, K. G. Reddy, K. Rajender Reddy, V. Syplyviy, N. M. Bass, K. Dickinson, C. Norris, D. Coakley, M. Mokhtarani, B. F. Scharschmidt // Hepatology. – 2014. – Vol. 54, N 3. – P. 1073–1083. |
Abstract: | Glycerol phenylbutyrate (GPB) lowers ammonia by providing an alternate pathway to urea for waste nitrogen excretion in the form of phenylacetyl glutamine, which is excreted in urine. This randomized, double-blind, placebo-controlled phase II trial enrolled 178 patients with cirrhosis, including 59 already taking rifaximin, who had experienced two or more hepatic encephalopathy (HE) events in the previous 6 months. The primary endpoint was the proportion of patients with HE events. Other endpoints included the time to first event, total number of events, HE hospitalizations, symptomatic days, and safety. GPB, at 6 mL orally twice-daily, significantly reduced the proportion of patients who experienced an HE event (21% versus 36%; P=0.02), time to first event (hazard ratio [HR]=0.56; P<0.05), as well as total events (35 versus 57; P=0.04), and was associated with fewer HE hospitalizations (13 versus 25; P=0.06). Among patients not on rifaximin at enrollment, GPB reduced the proportion of patients with an HE event (10% versus 32%; P<0.01), time to first event (HR=0.29; P<0.01), and total events (7 versus 31; P<0.01). Plasma ammonia was significantly lower in patients on GPB and correlated with HE events when measured either at baseline or during the study. A similar proportion of patients in the GPB (79%) and placebo groups (76%) experienced adverse events. |
URI: | https://repo.knmu.edu.ua/handle/123456789/7763 |
Appears in Collections: | Наукові праці. Кафедра загальної хірургії |
Files in This Item:
File | Description | Size | Format | |
---|---|---|---|---|
hep26611.pdf | 665,69 kB | Adobe PDF | View/Open |
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.