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Combined analysis of randomized controlled trials of ursodeoxycholic acid in primary biliary cirrhosis.

Abstract：

BACKGROUND & AIMS:Long-term ursodeoxycholic acid (UDCA) therapy slows the progression of primary biliary cirrhosis. This study examined the effect of UDCA therapy on survival free of liver transplantation in a large group of patients. METHODS:Data from three clinical trials were combined in which patients with primary biliary cirrhosis were randomly assigned to receive UDCA (n = 273) or placebo (n = 275). After 2 years, patients from French and Canadian studies received UDCA for up to 2 years. Patients from the American study remained on their assigned treatment for up to 4 years. RESULTS:Survival free of liver transplantation was significantly improved in the patients treated with UDCA compared with the patients originally assigned to placebo (P < 0.001; relative risk, 1.9; 95% confidence interval, 1.3-2.8). Subgroup analyses showed that survival free of liver transplantation was significantly improved in medium- and high-risk groups (serum bilirubin level, 1.4 to 3.5 or > 3.5 mg/dL; P < 0.0001 and P < 0.03, respectively) and histological stage IV subgroup (P < 0.01). CONCLUSIONS:Long-term UDCA therapy improves survival free of liver transplantation in patients with moderate or severe disease. An effect in patients with mild disease is probably not found because they do not progress to end-stage disease in 4 years.

journal_name

Gastroenterology

journal_title

Gastroenterology

authors

Poupon RE,Lindor KD,Cauch-Dudek K,Dickson ER,Poupon R,Heathcote EJ

doi

10.1016/s0016-5085(97)70183-5

subject

Has Abstract

pub_date

1997-09-01 00:00:00

pages

884-90

issue

3

eissn

0016-5085

issn

1528-0012

pii

S0016508597004265

journal_volume

113

pub_type

杂志文章

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