Document Detail

Cholic acid for hepatic steatosis in patients with lipodystrophy: a randomized, controlled trial.
MedLine Citation:
PMID:  23447519     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: Hepatic steatosis is a common complication in patients with lipodystrophies and can lead to cirrhosis. There is no proven effective therapy for hepatic steatosis, but cholic acid (CA), a farnesoid X receptor agonist, has previously been shown to reduce hepatic triglyceride (TG) content in mice and serum TG in humans. Our objective was to assess clinical efficacy and tolerability of CA therapy in patients with lipodystrophy and hepatic steatosis.
DESIGN: A randomized, double-blind, placebo-controlled, crossover study.
METHODS: Eighteen patients with genetic or autoimmune lipodystrophies and elevated hepatic TG content participated in the study. The intervention was CA (15 mg/kg per day) compared with placebo for a period of 6 months each. Hepatic TG content, the primary outcome variable, was measured with (1)H magnetic resonance spectroscopy at baseline and at 3 and 6 months during each study period. Levels of serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase (GGT), and TG were secondary end points of the study.
RESULTS: Compared with placebo, CA did not reduce (median (interquartile range) hepatic TG content (14.8% (9.4-19.0%) vs 15.9% (10.5-26.5%) respectively; P=0.42) or serum TG ((340 mg/dl (233-433 mg/dl) vs 390 mg/dl (233-595 mg/dl) respectively; P=0.45)). CA therapy also did not change AST, ALT, or GGT levels. Two patients developed diarrhea and excessive flatus while taking CA and these symptoms resolved after reducing the dose of CA.
CONCLUSION: CA was well tolerated but did not reduce hepatic TG content in patients with lipodystrophy.
Zahid Ahmad; Lalitha Subramanyam; Lidia Szczepaniak; Vinaya Simha; Beverley Adams-Huet; Abhimanyu Garg
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.     Date:  2013-04-15
Journal Detail:
Title:  European journal of endocrinology / European Federation of Endocrine Societies     Volume:  168     ISSN:  1479-683X     ISO Abbreviation:  Eur. J. Endocrinol.     Publication Date:  2013 May 
Date Detail:
Created Date:  2013-04-16     Completed Date:  2013-06-06     Revised Date:  2014-01-28    
Medline Journal Info:
Nlm Unique ID:  9423848     Medline TA:  Eur J Endocrinol     Country:  England    
Other Details:
Languages:  eng     Pagination:  771-8     Citation Subset:  IM    
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MeSH Terms
Alanine Transaminase / blood
Aspartate Aminotransferases / blood
Cholic Acid / pharmacology,  therapeutic use*
Cross-Over Studies
Double-Blind Method
Fatty Liver / drug therapy*,  etiology,  metabolism
Lipodystrophy / complications*,  metabolism
Liver / drug effects*,  metabolism
Middle Aged
Treatment Outcome
Triglycerides / metabolism
gamma-Glutamyltransferase / blood
Grant Support
Reg. No./Substance:
0/Triglycerides; EC; EC Aminotransferases; EC Transaminase; G1JO7801AE/Cholic Acid

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