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

Don C. Rockey, John M. Vierling, Parvez Mantry, Marwan Ghabril, Robert S. Brown, Olga Alexeeva, Igor A. Zupanets, Vladimir Grinevich, Andrey Baranovsky, Larysa Dudar, Galyna Fadieienko, Nataliya Kharchenko, Iryna Klaryts'ka, Vyacheslav Morozov, Priya Grewal, Timothy Mccashland, K. Gautham Reddy, K. Rajender Reddy, Vasyl Syplyviy, Nathan M. Bass & 31 others Klara Dickinson, Catherine Norris, Dion Coakley, Masoud Mokhtarani, Bruce F. Scharschmidt, A. Ahmed, L. Balart, B. Berk, K. Brown, A. Frolov, C. Howell, O. Khrustalev, M. Lucey, B. Maliakkal, A. Mendoza, C. O'Brien, R. O'Shea, M. Porayko, V. Radchenko, R. Rahimi, N. Shah, K. Shetty, S. Sigal, G. Storozhakov, S. Zucker, H. Tobias, M. Voigt, S. Weinman, D. Wolf, K. Zhidkov, T. Zvyagintseva

Research output: Contribution to journalArticle

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

Original languageEnglish (US)
Pages (from-to)1073-1083
Number of pages11
JournalHepatology
Volume59
Issue number3
DOIs
StatePublished - Mar 2014
Externally publishedYes

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Hepatic Encephalopathy
Double-Blind Method
rifaximin
Glutamine
Ammonia
Urea
Hospitalization
Fibrosis
Nitrogen
Placebos
Urine
Safety
glycerol phenylbutyrate

ASJC Scopus subject areas

  • Hepatology

Cite this

Rockey, D. C., Vierling, J. M., Mantry, P., Ghabril, M., Brown, R. S., Alexeeva, O., ... Zvyagintseva, T. (2014). Randomized, double-blind, controlled study of glycerol phenylbutyrate in hepatic encephalopathy. Hepatology, 59(3), 1073-1083. https://doi.org/10.1002/hep.26611

Randomized, double-blind, controlled study of glycerol phenylbutyrate in hepatic encephalopathy. / 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.; Ahmed, A.; Balart, L.; Berk, B.; Brown, K.; Frolov, A.; Howell, C.; Khrustalev, O.; Lucey, M.; Maliakkal, B.; Mendoza, A.; O'Brien, C.; O'Shea, R.; Porayko, M.; Radchenko, V.; Rahimi, R.; Shah, N.; Shetty, K.; Sigal, S.; Storozhakov, G.; Zucker, S.; Tobias, H.; Voigt, M.; Weinman, S.; Wolf, D.; Zhidkov, K.; Zvyagintseva, T.

In: Hepatology, Vol. 59, No. 3, 03.2014, p. 1073-1083.

Research output: Contribution to journalArticle

Rockey, DC, Vierling, JM, Mantry, P, Ghabril, M, Brown, RS, Alexeeva, O, Zupanets, IA, Grinevich, V, Baranovsky, A, Dudar, L, Fadieienko, G, Kharchenko, N, Klaryts'ka, I, Morozov, V, Grewal, P, Mccashland, T, Reddy, KG, Reddy, KR, Syplyviy, V, Bass, NM, Dickinson, K, Norris, C, Coakley, D, Mokhtarani, M, Scharschmidt, BF, Ahmed, A, Balart, L, Berk, B, Brown, K, Frolov, A, Howell, C, Khrustalev, O, Lucey, M, Maliakkal, B, Mendoza, A, O'Brien, C, O'Shea, R, Porayko, M, Radchenko, V, Rahimi, R, Shah, N, Shetty, K, Sigal, S, Storozhakov, G, Zucker, S, Tobias, H, Voigt, M, Weinman, S, Wolf, D, Zhidkov, K & Zvyagintseva, T 2014, 'Randomized, double-blind, controlled study of glycerol phenylbutyrate in hepatic encephalopathy', Hepatology, vol. 59, no. 3, pp. 1073-1083. https://doi.org/10.1002/hep.26611
Rockey DC, Vierling JM, Mantry P, Ghabril M, Brown RS, Alexeeva O et al. Randomized, double-blind, controlled study of glycerol phenylbutyrate in hepatic encephalopathy. Hepatology. 2014 Mar;59(3):1073-1083. https://doi.org/10.1002/hep.26611
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. ; Ahmed, A. ; Balart, L. ; Berk, B. ; Brown, K. ; Frolov, A. ; Howell, C. ; Khrustalev, O. ; Lucey, M. ; Maliakkal, B. ; Mendoza, A. ; O'Brien, C. ; O'Shea, R. ; Porayko, M. ; Radchenko, V. ; Rahimi, R. ; Shah, N. ; Shetty, K. ; Sigal, S. ; Storozhakov, G. ; Zucker, S. ; Tobias, H. ; Voigt, M. ; Weinman, S. ; Wolf, D. ; Zhidkov, K. ; Zvyagintseva, T. / Randomized, double-blind, controlled study of glycerol phenylbutyrate in hepatic encephalopathy. In: Hepatology. 2014 ; Vol. 59, No. 3. pp. 1073-1083.
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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",
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AU - Rockey, Don C.

AU - Vierling, John M.

AU - Mantry, Parvez

AU - Ghabril, Marwan

AU - Brown, Robert S.

AU - Alexeeva, Olga

AU - Zupanets, Igor A.

AU - Grinevich, Vladimir

AU - Baranovsky, Andrey

AU - Dudar, Larysa

AU - Fadieienko, Galyna

AU - Kharchenko, Nataliya

AU - Klaryts'ka, Iryna

AU - Morozov, Vyacheslav

AU - Grewal, Priya

AU - Mccashland, Timothy

AU - Reddy, K. Gautham

AU - Reddy, K. Rajender

AU - Syplyviy, Vasyl

AU - Bass, Nathan M.

AU - Dickinson, Klara

AU - Norris, Catherine

AU - Coakley, Dion

AU - Mokhtarani, Masoud

AU - Scharschmidt, Bruce F.

AU - Ahmed, A.

AU - Balart, L.

AU - Berk, B.

AU - Brown, K.

AU - Frolov, A.

AU - Howell, C.

AU - Khrustalev, O.

AU - Lucey, M.

AU - Maliakkal, B.

AU - Mendoza, A.

AU - O'Brien, C.

AU - O'Shea, R.

AU - Porayko, M.

AU - Radchenko, V.

AU - Rahimi, R.

AU - Shah, N.

AU - Shetty, K.

AU - Sigal, S.

AU - Storozhakov, G.

AU - Zucker, S.

AU - Tobias, H.

AU - Voigt, M.

AU - Weinman, S.

AU - Wolf, D.

AU - Zhidkov, K.

AU - Zvyagintseva, T.

PY - 2014/3

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