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

Autor: Don C. Rockey, K. Rajender Reddy, Stephen D. Zucker, Neeral L. Shah, David C. Wolf, Robert S. Rahimi, A. Mendoza, Iryna Klaryts'ka, Dion F. Coakley, Timothy M. McCashland, Larysa Dudar, Charles D. Howell, Galyna Fadieienko, K. Gautham Reddy, O. Khrustalev, Andrey Baranovsky, Vladimir Grinevich, Olga Alexeeva, Marwan Ghabril, Robert O'Shea, Parvez S. Mantry, K. Zhidkov, Priya Grewal, Benedict Maliakkal, T. Zvyagintseva, Masoud Mokhtarani, Christopher B. O'Brien, Bruce F. Scharschmidt, V. Radchenko, B. Berk, A. Frolov, Vasyl Syplyviy, Samuel H. Sigal, Kimberly A Brown, G. Storozhakov, Robert S. Brown, Igor A. Zupanets, Hillel Tobias, Nathan M. Bass, John M. Vierling, Kirti Shetty, Michael R. Lucey, Klara Dickinson, Michael D. Voigt, Nataliya Kharchenko, Vyacheslav Morozov, Steven A. Weinman, Catherine Norris, M. Porayko, Luis A. Balart, Aijaz Ahmed
Rok vydání: 2014
Předmět:
Zdroj: Hepatology (Baltimore, Md.)
ISSN: 1527-3350
0270-9139
Popis: 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
Databáze: OpenAIRE