2005
DOI: 10.1053/j.gastro.2005.08.017
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High-Dose Ursodeoxycholic Acid in Primary Sclerosing Cholangitis: A 5-Year Multicenter, Randomized, Controlled Study

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Cited by 348 publications
(246 citation statements)
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“…Previous studies led us to believe that UDCA would be safe and beneficial (9)(10)(11)(12). Patients with primary biliary cirrhosis, in whom a dose of 13-15 mg/kg/day has been approved by the Food and Drug Administration have not had more adverse events when treated with higher doses up to 25 or 30 mg/kg/day (14).…”
Section: Discussionmentioning
confidence: 99%
“…Previous studies led us to believe that UDCA would be safe and beneficial (9)(10)(11)(12). Patients with primary biliary cirrhosis, in whom a dose of 13-15 mg/kg/day has been approved by the Food and Drug Administration have not had more adverse events when treated with higher doses up to 25 or 30 mg/kg/day (14).…”
Section: Discussionmentioning
confidence: 99%
“…The therapy was associated with increased risk of esophagogastric varices and mortality, suggesting a risk of high-dose UDCA therapy for patients with primary sclerosing cholangitis [100]. On the basis of variable data on its effects on liver tests and survival [100][101][102][103], UDCA therapy is not recommended in the American Association for the Study of Liver Diseases (AASLD) [104] and European Association for the Study of the Liver (EASL) [105] guidelines. We propose its careful use as a treatment option after assessment of the benefit-risk balance.…”
Section: Antifibrotic Therapymentioning
confidence: 99%
“…Higher doses of UCDA (20-30 mg/kg/day) have been shown to be detrimental, rather than to have any substantial clinical benefit [72][73][74][75][76]. UCDA does not improve liver histology or liver transplant free survival, nor does it prevent the development of cholangiocarcinoma, colonic adenomas, colon cancer or incidence of death [73,[77][78][79].…”
Section: Management Of Pscmentioning
confidence: 99%