PMID- 29431335
OWN - NLM
STAT- MEDLINE
DCOM- 20190228
LR  - 20190228
IS  - 1827-1642 (Electronic)
IS  - 1121-421X (Linking)
VI  - 64
IP  - 3
DP  - 2018 Sep
TI  - Open-label study of ademetionine for the treatment of intrahepatic cholestasis 
      associated with alcoholic liver disease.
PG  - 208-219
LID - 10.23736/S1121-421X.18.02461-3 [doi]
AB  - 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 conjugated 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. Subjects 
      with a baseline serum conjugated 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 baseline to end of treatment with an 
      increase in the proportion of subjects with no symptoms. Ademetionine showed 
      significant improvements in primary efficacy parameters alkaline phosphatase 
      (ALP) and gamma-glutamyltransferase (gammaGT) (P<0.0001). Although decreases of ALP were 
      higher for subjects initially treated with IV ademetionine, these subjects also 
      had higher baseline values. No safety concerns with ademetionine arose with 
      respect to the severity or frequency of adverse events (AEs) during the treatment 
      period, laboratory parameters, and vital signs. CONCLUSIONS: Administration of 
      oral or IV/oral ademetionine step-therapy for 8 weeks to subjects with IHC due to 
      ALD was safe and provided a significant improvement of disease burden.
FAU - Ivashkin, Vladimir T
AU  - Ivashkin VT
AD  - I.M. Sechenov First Moscow State Medical University, Moscow, Russia.
FAU - Maevskaya, Marina V
AU  - Maevskaya MV
AD  - I.M. Sechenov First Moscow State Medical University, Moscow, Russia - 
      liver.orc@mail.ru.
FAU - Kobalava, Zhanna D
AU  - Kobalava ZD
AD  - Peoples' Friendship University of Russia, Moscow, Russia.
FAU - Uspenskiy, Yuriy P
AU  - Uspenskiy YP
AD  - Hospital of the Holy Martyr Elizabeth, Saint-Petersburg, Russia.
FAU - Fominih, Julia A
AU  - Fominih JA
AD  - Hospital of the Holy Martyr Elizabeth, Saint-Petersburg, Russia.
FAU - Rozanov, Alexander V
AU  - Rozanov AV
AD  - Moscow Hospital of the Russian Academy of Sciences (Troitsk), Peoples' Friendship 
      University of Russia, Moscow, Russia.
FAU - Tolkacheva, Veronica V
AU  - Tolkacheva VV
AD  - Peoples' Friendship University of Russia, Moscow, Russia.
AD  - Affiliate Hospital of the Russian Academy of Sciences, Troitsk, Russia.
FAU - Sotnikova, Tatiana I
AU  - Sotnikova TI
AD  - City Clinical Hospital named after S.P. Botkin, Moscow, Russia.
FAU - Alikhanov, Bagdadi A
AU  - Alikhanov BA
AD  - Central Clinical Hospital of the Russian Academy of Sciences, Moscow, Russia.
FAU - Gorbacheva, Irina A
AU  - Gorbacheva IA
AD  - St. Petersburg State Health Institution Clinical Hospital of St. Luke, Saint 
      Petersburg, Russia.
FAU - Ershova, Olga B
AU  - Ershova OB
AD  - Clinical Emergency Hospital named NV Solovyov, Yaroslavl, Russia.
FAU - Znakhyrenko, Antonina A
AU  - Znakhyrenko AA
AD  - Autonomous Nonprofit Organization Petersburg Metro Polyclinic, Saint Petersburg, 
      Russia.
FAU - Sokolov, Kirill A
AU  - Sokolov KA
AD  - Abbott Laboratories, LLC, Chicago, IL, USA.
FAU - Sander-Struckmeier, Suntje
AU  - Sander-Struckmeier S
AD  - Abbott Laboratories, LLC, Chicago, IL, USA.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20180208
PL  - Italy
TA  - Minerva Gastroenterol Dietol
JT  - Minerva gastroenterologica e dietologica
JID - 9109791
RN  - 7LP2MPO46S (S-Adenosylmethionine)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Cholestasis, Intrahepatic/complications/*drug therapy
MH  - Female
MH  - Humans
MH  - Liver Diseases, Alcoholic/complications
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - S-Adenosylmethionine/*administration & dosage
MH  - Young Adult
EDAT- 2018/02/13 06:00
MHDA- 2019/03/01 06:00
CRDT- 2018/02/13 06:00
PHST- 2018/02/13 06:00 [pubmed]
PHST- 2019/03/01 06:00 [medline]
PHST- 2018/02/13 06:00 [entrez]
AID - S1121-421X.18.02461-3 [pii]
AID - 10.23736/S1121-421X.18.02461-3 [doi]
PST - ppublish
SO  - Minerva Gastroenterol Dietol. 2018 Sep;64(3):208-219. doi: 
      10.23736/S1121-421X.18.02461-3. Epub 2018 Feb 8.