American Journal of Clinical Medicine Research
ISSN (Print): 2328-4005 ISSN (Online): 2328-403X Website: https://www.sciepub.com/journal/ajcmr Editor-in-chief: Dario Galante
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American Journal of Clinical Medicine Research. 2016, 4(1), 7-10
DOI: 10.12691/ajcmr-4-1-2
Open AccessArticle

Budesonide in Severe Alcoholic Hepatitis: Results of the Original Research

Komkova I.I.1, Tkachenko P.E.1, , Maevskaya M.V.1 and Ivashkin V.T.1

1Hepatology department, I.M.Sechenov First State Medical University, Moscow, Russia

Pub. Date: February 25, 2016

Cite this paper:
Komkova I.I., Tkachenko P.E., Maevskaya M.V. and Ivashkin V.T.. Budesonide in Severe Alcoholic Hepatitis: Results of the Original Research. American Journal of Clinical Medicine Research. 2016; 4(1):7-10. doi: 10.12691/ajcmr-4-1-2

Abstract

Background and aim: Severe alcoholic hepatitis (AH) is a life-threatening alcoholic liver disease with a potential of 30-40% mortality at 1 month. While steroids remain to be a first line therapy, there is a need in alternative treatment. The aim of the study is to compare efficacy and safety of budesonide and prednisolone in treatment of severe AH and to determine predictors of none-response, predictors of short-term mortality. Methods: 37 patients with severe AH were randomized in 2 groups and enrolled in the prospective trial. Group 1 (n=17) patients received budesonide 9 mg/daily per os, group 2 (n=20) patients were managed with prednisolone 40 mg/daily per os. Treatment duration was 28 days. Response criteria – Lille model. Results: There were no significant differences in short-term survival (р = 0,857). In group 2 adverse events were statistically more frequently than in group 1 (70% vs. 26,7%, р = 0,011). Hepatorenal syndrome occurred more frequently in group 2 (р = 0,033). Predictors of non-response were MELD score (р = 0,009), ABIC score (р = 0,011), hepatic encephalopathy (p=0,035), total bilirubin (p=0,016). Predictors of mortality were Lille score (p=0,018), serum glucose (p=0,017), total bilirubin level at the 7th day of the therapy (p=0,030). Conclusions: Budesonide therapy for patients with severe alcoholic hepatitis showed same efficacy as prednisolone treatment with significantly less adverse events. Budesonide appears to be effective in prevention of hepatorenal syndrome.

Keywords:
severe alcoholic hepatitis prednisolone budesonide hepatorenal syndrome

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References:

[1]  Mayevskaya M.V., Morozova M.A., Ivashkin V.T. Algorithm of management of patient with alcohol-induced liver disease. Russian journal of gastroenterology, hepatology and coloproctology. 2011. Vol. 17 (6), p. 4-10.
 
[2]  Bueverov A.O., Mayevskaya, M.V., Ivashkin V.T. Differentiated management of alcoholic liver disease.– Russian journal of gastroenterology, hepatology and coloproctology. 2005. Vol. 15 (5), p. 4-10.
 
[3]  Ivashkin V.T. Gastroenterology: textbook – “Geotar-Media”, 2015.
 
[4]  Mayevskaya M.V. Alcohol, alcoholism and related consequences. Russian journal of gastroenterology, hepatology and coloproctology. 2013. Vol. 23 (6), p. 43-48.
 
[5]  Fernández-Checa JC. Alcohol-induced liver disease: when fat and oxidative stress meet. Ann Hepatol. 2003 Apr-Jun; 2 (2): 69-75.
 
[6]  Limuro Y., Frankenberg M., Arteel G. et al. Female rats exhibit greater susceptibility to early alcohol-induced liver injury than males. Am. J. Physiol. 1997; 272: 1186-1194.
 
[7]  Naveau S., Cassard-Doulcier A., Njiké-Nakseu M., Bouchet-Delbos L., Barri-Ova N., Boujedidi H., Dauvois B. et. al. Harmful effect of adipose tissue on liver lesions in patients with alcoholic liver disease. J Hepatol. 2010 Jun; 52 (6): 895-902. Epub 2010 Mar 24.
 
[8]  Mathurin P. Therapeutic management of alcoholic hepatitis. Clinical Research in Hepatology and Gastroenterology. 2015 Jul; 39: 41-45.
 
[9]  O’Shea R.S., Dasarathy S., McCullough A.J. et al. Alcoholic liver disease. AASLD practice guidelines. Hepatology. 2010; 51(1): 307-328.
 
[10]  Sheth M, Riggs M, Patel T. Utility of the Mayo End-Stage Liver Disease (MELD) score in assessing prognosis of patients with alcoholic hepatitis. BMC Gastroenterol. 2002; 2: 2.
 
[11]  Mayevskaya M.V., Morozova M.A., Ivashkin V.T. Management of patients with alcoholic liver disease. - Russian journal of gastroenterology, hepatology and coloproctology. 2007; 17(6): 1-10.
 
[12]  P. Maturin, M.R. Lucey. Management of alcoholic hepatitis. Journal of Hepatology. 2012; 56, supplement 1: 39-45.
 
[13]  Manns MP, Woynarowski M, Kreisel W, Lurie Y, Rust C, Zuckerman E, Bahr MJ et. al. European AIH-BUC-Study Group Budesonide induces remission more effectively than prednisone in a controlled trial of patients with autoimmune hepatitis. Gastroenterology. 2010 Oct; 139(4): 1198-206. Epub 2010 Jun 22.
 
[14]  Zandieh I, Krygier D, Wong V, Howard J, Worobetz L, Minuk G, Witt-Sullivan H et. al. The use of budesonide in the treatment of autoimmune hepatitis in Canada. Can J Gastroenterol. 2008 Apr; 22(4): 388-92.
 
[15]  Czaja AJ. Autoimmune hepatitis: Focusing on treatments other than steroids. Can J Gastroenterol. 2012 Sep; 26(9): 615-20.
 
[16]  D'Haens GR, Kovács A, Vergauwe P, Nagy F, Molnár T, Bouhnik Y, Weiss W et. al. Clinical trial: Preliminary efficacy and safety study of a new Budesonide-MMX® 9 mg extended-release tablets in patients with active left-sided ulcerative colitis. J Crohns Colitis. 2010 Jun; 4(2): 153-60. Epub 2009 Oct 24.
 
[17]  Seow CH, Benchimol EI, Griffiths AM, Otley AR, Steinhart AH. Budesonide for induction of remission in Crohn's disease. Cochrane Database Syst Rev. 2008 Jul 16; (3).
 
[18]  Wagner M, Lampinen M, Sangfelt P, Agnarsdottir M, Carlson M. Budesonide treatment of patients with collagenous colitis restores normal eosinophil and T-cell activity in the colon. Inflamm Bowel Dis. 2010 Jul; 16(7): 1118-26.
 
[19]  Bush KR, Bradley KA, McDonell MB, Malone T, Fihn SD; Screening for problem drinking: Comparison of CAGE and AUDIT. Ambulatory Care Quality Improvement Project. J Gen Intern Med. 1998 Jun; 13 (6): 379-88.
 
[20]  Louvet A, Naveau S, Abdelnour M, Ramond MJ, Diaz E, Fartoux L, Mathurin P. et. al. The Lille model: a new tool for therapeutic strategy in patients with severe alcoholic hepatitis treated with steroids. Hepatology. 2007 Jun; 45 (6): 1348-54.
 
[21]  Hempfling W., Grunhage F., Dilger K., Reichel C, Beuers U., Sauerbruch T. Pharmacokinetics and Pharmacodynamic Action of Budesonide in Early- and Late-Stage Primary Biliary Cirrhosis. Hepatology. 2003 Jul; 38 (1): 196-202.
 
[22]  Efe C., Ozaslan E., Kav T. Liver fibrosis may reduce the efficacy of budesonide in the treatment of autoimmune hepatitis and overlap syndrome. Autoimmunity Reviews 11 (2012): 330-33.
 
[23]  Mederacke I., Helfritz F., Puls F. Budd-Chiary syndrome after treatment with budesonide in a cirrhotic patient with autoimmune hepatitis. Annals of Hepatology. 2012; 11(1), p 143-144.