Randomized, double‐blind, controlled study of glycerol phenylbutyrate in hepatic encephalopathy

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 a...

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Published in:Hepatology (Baltimore, Md.) Md.), 2014-03, Vol.59 (3), p.1073-1083
Main Authors: Rockey, Don C., Vierling, John M., Mantry, Parvez, Ghabril, Marwan, Brown, Robert S., Alexeeva, Olga, Zupanets, Igor A., Grinevich, Vladimir, Baranovsky, Andrey, Dudar, Larysa, Fadieienko, Galyna, Kharchenko, Nataliya, Klaryts'ka, Iryna, Morozov, Vyacheslav, Grewal, Priya, McCashland, Timothy, Reddy, K. Gautham, Reddy, K. Rajender, Syplyviy, Vasyl, Bass, Nathan M., Dickinson, Klara, Norris, Catherine, Coakley, Dion, Mokhtarani, Masoud, Scharschmidt, Bruce F.
Format: Article
Language:English
Subjects:
Adult
Aged
Ammonia - blood
Ammonia - metabolism
Double-Blind Method
Drug therapy
Female
Glutamine - analogs & derivatives
Glutamine - urine
Glycerol
Glycerol - administration & dosage
Glycerol - analogs & derivatives
Glycerol - pharmacokinetics
Hepatic Encephalopathy - drug therapy
Hepatic Encephalopathy - metabolism
Hepatology
Humans
Hyperammonemia - drug therapy
Hyperammonemia - metabolism
Liver cirrhosis
Liver Failure/Cirrhosis/Portal Hypertension
Male
Middle Aged
Phenylbutyrates - administration & dosage
Phenylbutyrates - pharmacokinetics
Treatment Outcome
Urea - urine
Young Adult
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Summary: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 
ISSN:0270-9139
1527-3350
DOI:10.1002/hep.26611