Open-label study of ademetionine for the treatment of intrahepatic cholestasis associated with alcoholic liver disease
Ivashkin V. T., Maevskaya M. V., Kobalava Z. D., Uspenskiy Y. P., Fominih J. A., Rozanov A. V., Tolkacheva V. V., Sotnikova T. I., Alikhanov B. A., Gorbacheva I. A., Ershova O. B., Znakhyrenko A. A., Sokolov K. A., Sander-Struckmeier S.
Minerva Gastroenterologica e Dietologica
Vol.64, Issue3, P. 208-219
Опубликовано: 2018
Тип ресурса: Статья
DOI:10.23736/S1121-421X.18.02461-3
Аннотация:
BACKGROUND: The effect of oral and/or parenteral ademetionine (500 mg intravenous [IV] and tablet formulation) on clinical symptoms and biochemical markers of intrahepatic cholestasis (IHC) was investigated in subjects with alcoholic liver disease (ALD) and compensated liver function. METHODS: Prospective, multicenter, open-label study consisting of a screening period and an 8-week treatment period and performed in subjects (18-75 years) with compensated ALD and confirmed IHC. Subjects with a baseline serum coniugated bilirubin value above normal range were initially treated with IV ademetionine for two weeks (500-800 mg daily) and continued with oral ademetionine 1500 mg daily for a further six weeks. Subiects with a baseline serum coniugated bilirubin value within normal range were treated with oral ademetionine for eight weeks. RESULTS: A total of 72 subjects were treated; 41 initially with IV ademetionine and 31 with oral ademetionine. Clinical symptoms status improved from baselin
Ключевые слова:
Alcoholic; Cholestasis; Liver diseases; S-adenosylmethionine
alanine aminotransferase; alkaline phosphatase; aspartate aminotransferase; bilirubin; bisoprolol; enalapril; gamma glutamyltransferase; gliclazide; heptral; metformin; ranitidine; s adenosylmethionine; spironolactone; ursodeoxycholic acid; s adenosylmethionine; adult; aged; alcohol consumption; alcohol liver disease; Article; chronic pancreatitis; controlled study; diabetes mellitus; female; gastritis; gastroesophageal reflux; human; hypertension; intrahepatic cholestasis; major clinical study; male; middle aged; multicenter study; peptic ulcer; prospective study; adolescent; alcohol liver disease; clinical trial; complication; intrahepatic cholestasis; young adult; Adolescent; Adult; Aged; Cholestasis, Intrahepatic; Female; Humans; Liver Diseases, Alcoholic; Male; Middle Aged; Prospective Studies; S-Adenosylmethionine; Young Adult
Язык текста: Английский
ISSN: 1121-421X
Ivashkin V. T. Vladimir Trofimovich 1939-
Maevskaya M. V. Marina Viktorovna 1958-
Kobalava Z. D.
Uspenskiy Y. P.
Fominih J. A.
Rozanov A. V.
Tolkacheva V. V.
Sotnikova T. I. Tat`yana Ivanovna 1958-
Alikhanov B. A.
Gorbacheva I. A.
Ershova O. B.
Znakhyrenko A. A.
Sokolov K. A.
Sander-Struckmeier S.
Ивашкин В. Т. Владимир Трофимович 1939-
Маевская М. В. Марина Викторовна 1958-
Кобалава З. Д.
Успенскиy Y. П.
Фоминих Й. А.
Розанов А. В.
Толкачева В. В.
Сотникова Т. И. Татьяна Ивановна 1958-
Алиханов Б. А.
Горбачева И. А.
Ершова О. Б.
Знахyренко А. А.
Соколов К. А.
Сандер-Струcкмеиер С.
Open-label study of ademetionine for the treatment of intrahepatic cholestasis associated with alcoholic liver disease
Текст визуальный непосредственный
Minerva Gastroenterologica e Dietologica
Edizioni Minerva Medica
Vol.64, Issue3 P. 208-219
2018
Статья
Alcoholic Cholestasis Liver diseases S-adenosylmethionine
alanine aminotransferase alkaline phosphatase aspartate aminotransferase bilirubin bisoprolol enalapril gamma glutamyltransferase gliclazide heptral metformin ranitidine s adenosylmethionine spironolactone ursodeoxycholic acid s adenosylmethionine adult aged alcohol consumption alcohol liver disease Article chronic pancreatitis controlled study diabetes mellitus female gastritis gastroesophageal reflux human hypertension intrahepatic cholestasis major clinical study male middle aged multicenter study peptic ulcer prospective study adolescent alcohol liver disease clinical trial complication intrahepatic cholestasis young adult Adolescent Adult Aged Cholestasis, Intrahepatic Female Humans Liver Diseases, Alcoholic Male Middle Aged Prospective Studies S-Adenosylmethionine Young Adult
BACKGROUND: The effect of oral and/or parenteral ademetionine (500 mg intravenous [IV] and tablet formulation) on clinical symptoms and biochemical markers of intrahepatic cholestasis (IHC) was investigated in subjects with alcoholic liver disease (ALD) and compensated liver function. METHODS: Prospective, multicenter, open-label study consisting of a screening period and an 8-week treatment period and performed in subjects (18-75 years) with compensated ALD and confirmed IHC. Subjects with a baseline serum coniugated bilirubin value above normal range were initially treated with IV ademetionine for two weeks (500-800 mg daily) and continued with oral ademetionine 1500 mg daily for a further six weeks. Subiects with a baseline serum coniugated bilirubin value within normal range were treated with oral ademetionine for eight weeks. RESULTS: A total of 72 subjects were treated; 41 initially with IV ademetionine and 31 with oral ademetionine. Clinical symptoms status improved from baselin