A prospective randomized controlled study of long-term combination therapy using ursodeoxycholic acid and bezafibrate in patients with primary biliary cirrhosis and dyslipidemia

American Journal of Gastroenterology

Volumn 110, Issue 3, 2015, Pages 423-431

  Hosonuma, Kenichi ^a   Sato, Ken ^b   Yamazaki, Yuichi ^b   Yanagisawa, Masatoshi ^c   Hashizume, Hiroaki ^b   Horiguchi, Norio ^b   Kakizaki, Satoru ^b   Kusano, Motoyasu ^d   Yamada, Masanobu ^b  

^a Toho Hospital   (Japan)

^b GUNMA UNIVERSITY   (Japan)

^c Heisei hidaka Clinic   (Japan)

^d GUNMA UNIVERSITY HOSPITAL   (Japan)

Author keywords

[No Author keywords available]

Indexed keywords

ALKALINE PHOSPHATASE; ASPARTATE AMINOTRANSFERASE; BEZAFIBRATE; BILIRUBIN; CREATINE KINASE; CREATININE; GAMMA INTERFERON; INTERLEUKIN 12; INTERLEUKIN 18; INTERLEUKIN 1BETA; INTERLEUKIN 6; SERUM ALBUMIN; TRIACYLGLYCEROL; TUMOR NECROSIS FACTOR ALPHA; URSODEOXYCHOLIC ACID; ANTILIPEMIC AGENT; CHOLAGOGUE;

ABNORMAL LABORATORY RESULT; ADULT; AGED; ALKALINE PHOSPHATASE BLOOD LEVEL; ARTICLE; CLINICAL ARTICLE; CLINICAL ASSESSMENT; CLINICAL EVALUATION; CONTROLLED STUDY; CREATINE KINASE BLOOD LEVEL; CREATININE BLOOD LEVEL; DISEASE SEVERITY; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; DYSLIPIDEMIA; FEMALE; HUMAN; KIDNEY DISEASE; LEG EDEMA; LONG TERM CARE; MALE; MIDDLE AGED; MONOTHERAPY; MULTICENTER STUDY; MYALGIA; OUTCOME ASSESSMENT; PATIENT RISK; PRIMARY BILIARY CIRRHOSIS; PRIORITY JOURNAL; PROGNOSIS; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; RISK FACTOR; SURVIVAL RATE; TREATMENT DURATION; BLOOD; CHEMICALLY INDUCED; CLINICAL TRIAL; COMPARATIVE STUDY; COMPLICATION; DOSE RESPONSE; DRUG COMBINATION; DRUG MONITORING; DYSLIPIDEMIAS; KIDNEY FAILURE; LIVER CIRRHOSIS, BILIARY; PROCEDURES; TIME; TREATMENT OUTCOME;

ALKALINE PHOSPHATASE; BEZAFIBRATE; CHOLAGOGUES AND CHOLERETICS; CREATININE; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG MONITORING; DRUG THERAPY, COMBINATION; DYSLIPIDEMIAS; FEMALE; HUMANS; HYPOLIPIDEMIC AGENTS; LIVER CIRRHOSIS, BILIARY; MALE; MIDDLE AGED; MYALGIA; PROGNOSIS; RENAL INSUFFICIENCY; SURVIVAL RATE; TIME; TREATMENT OUTCOME; URSODEOXYCHOLIC ACID;

EID: 84924495097     PISSN: 00029270     EISSN: 15720241     Source Type: Journal    
DOI: 10.1038/ajg.2015.20     Document Type: Article

References (32)

1. Shi J , Wu C , Lin Y et al. Long-Term eff ects of mid-dose ursodeoxycholic acid in primary biliary cirrhosis: A meta-analysis of randomized controlled trials . Am J Gastroenterol 2006 ; 101 : 1529-38
2. ter Borg PC , Schalm SW , Hansen BE et al. Prognosis of ursodeoxycholic Acid-Treated patients with primary biliary cirrhosis. Results of a 10-yr cohort study involving 297 patients . Am J Gastroenterol 2006 ; 101 : 2044-50
3. Corpechot C , Carrat F , Poupon R et al. Primary biliary cirrhosis: Incidence and predictive factors of cirrhosis development in ursodiol-Treated patients. Gastroenterology 2002 ; 122 : 652-8
4. Combes B , Emerson SS , Flye NL et al. Methotrexate (MTX) plus ursodeoxycholic acid (UDCA) in the treatment of primary biliary cirrhosis. Hepatology 2005 ; 42 : 1184-93
5. The results of a randomized double blind controlled trial evaluating malotilate in primary biliary cirrhosis. A European multicentre study group. J Hepatol 1993 ; 17 : 227-35
6. Angulo P , Patel T , Jorgensen RA et al. Silymarin in the treatment of patients with primary biliary cirrhosis with a suboptimal response to ursodeoxycholic acid . Hepatology 2000 ; 32 : 897-900
7. Myers RP , Swain MG , Lee SS et al. B-cell depletion with rituximab in patients with primary biliary cirrhosis refractory to ursodeoxycholic acid. Am J Gastroenterol 2013 ; 108 : 933-41
8. Day AP , Feher MD , Chopra R et al. The eff ect of bezafi brate treatment on serum alkaline phosphatase isoenzyme activities . Metabolism 1993 ; 42 : 839-42
9. Itakura J , Izumi N , Nishimura Y et al. Prospective randomized crossover trial of combination therapy with bezafi brate and UDCA for primary biliary cirrhosis . Hepatol Res 2004 ; 29 : 216-22
10. Iwasaki S , Tsuda K , Ueta H et al. Benefi cial eff ects of bezafi brate in ursodeoxycholic acid resistant pre-cirrhotic primary biliary cirrhosis . Hepatol Res 1999 ; 16 : 12-18
11. Iwasaki S , Ohira H , Nishiguchi S et al. The effi cacy of ursodeoxycholic acid and bezafi brate combination therapy for primary biliary cirrhosis: A prospective, multicenter study . Hepatol Res 2008 ; 38 : 557-64
12. Takeuchi Y , Ikeda F , Fujioka S et al. Additive improvement induced by bezafi brate in patients with primary biliary cirrhosis showing refractory response to ursodeoxycholic acid . J Gastroenterol Hepatol 2011 ; 26 : 1395-401
13. Scheuer P , Lefk owitch J . Liver Biopsy Interpretation WB Saunders : London, UK , 1994
14. Pares A , Caballeria L , Rodes J . Excellent long-Term survival in patients with primary biliary cirrhosis and biochemical response to ursodeoxycholic Acid . Gastroenterology 2006 ; 130 : 715-20
15. Kumagi T , Guindi M , Fischer SE et al. Baseline ductopenia and treatment response predict long-Term histological progression in primary biliary cirrhosis . Am J Gastroenterol 2010 ; 105 : 2186-94
16. Corpechot C , Abenavoli L , Rabahi N et al. Biochemical response to ursodeoxycholic acid and long-Term prognosis in primary biliary cirrhosis. Hepatology 2008 ; 48 : 871-7
17. Kuiper EM , Hansen BE , de Vries RA et al. Improved prognosis of patients with primary biliary cirrhosis that have a biochemical response to ursodeoxycholic acid . Gastroenterology 2009 ; 136 : 1281-7
18. Poupon RE , Balkau B , Eschwege E et al. A multicenter, controlled trial of ursodiol for the treatment of primary biliary cirrhosis. UDCA-PBC Study Group . N Engl J Med 1991 ; 324 : 1548-54
19. Grambsch PM , Dickson ER , Wiesner RH et al. Application of the Mayo primary biliary cirrhosis survival model to Mayo liver transplant patients. Mayo Clin Proc 1989 ; 64 : 699-704
20. Yamano T , Higashi T , Nouso K et al. Serum interferon-gamma-inducing factor/IL-18 levels in primary biliary cirrhosis . Clin Exp Immunol 2000 ; 122 : 227-31
21. Rennie D . CONSORT revised-improving the reporting of randomized trials . JAMA 2001 ; 285 : 2006-7
22. Marschall HU , Wagner M , Zollner G et al. Complementary stimulation of hepatobiliary transport and detoxifi cation systems by rifampicin and ursodeoxycholic acid in humans . Gastroenterology 2005 ; 129 : 476-85
23. Ikegami T , Matsuzaki Y . Ursodeoxycholic acid: Mechanism of action and novel clinical applications . Hepatol Res 2008 ; 38 : 123-31
24. Willson TM , Brown PJ , Sternbach DD et al. The PPARs: From orphan receptors to drug discovery . J Med Chem 2000 ; 43 : 527-50
25. Kok T , Bloks VW , Wolters H et al. Peroxisome proliferator-activated receptor alpha (PPARalpha)-mediated regulation of multidrug resistance 2 (Mdr2) expression and function in mice . Biochem J 2003 ; 369 : 539-47
26. Honda A , Ikegami T , Nakamuta M et al. Anticholestatic eff ects of bezafi -brate in patients with primary biliary cirrhosis treated with ursodeoxycholic acid . Hepatology 2013 ; 57 : 1931-41
27. Xia R , Tang Y , Huang Y et al. TNFSF9 expression in primary biliary cirrhosis and its clinical signifi cance . Cytokine 2010 ; 50 : 311-6
28. Dohmen K , Tanaka H , Haruno M . Eff ectiveness of fenofi brate in comparison to bezafi brate for patients with asymptomatic primary biliary cirrhosis. Fukuoka Igaku Zasshi 2013 ; 104 : 350-61
29. Han XF , Wang QX , Liu Y et al. Effi cacy of fenofi brate in Chinese patients with primary biliary cirrhosis partially responding to ursodeoxycholic acid therapy . J Dig Dis 2012 ; 13 : 219-24
30. Liberopoulos EN , Florentin M , Elisaf MS et al. Fenofi brate in primary biliary cirrhosis: A pilot study . Open Cardiovasc Med J 2010 ; 4 : 120-6
31. Dohmen K , Mizuta T , Nakamuta M et al. Fenofi brate for patients with asymptomatic primary biliary cirrhosis . World J Gastroenterol 2004 ; 10 : 894-8
32. Zhao YY , Weir MA , Manno M et al. New fi brate use and acute renal outcomes in elderly adults: A population-based study . Ann Intern Med 2012 ; 156 : 560-9