High Dose Ursodeoxycholic Acid for the Treatment of Primary Sclerosing Cholangitis
| Autor: | Keith D. Lindor, Kris V. Kowdley, Velimir A. C. Luketic, M. Edwyn Harrison, Timothy McCashland, Alex S. Befeler, Denise Harnois, Roberta Jorgensen, Jan Petz, Jill Keach, Jody Mooney, Carol Sargeant, Julie Braaten, Tamara Bernard, Debra King, Ellen Miceli, Jeff Schmoll, Tanya Hoskin, Prabin Thapa, Felicity Enders |
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| Jazyk: | angličtina |
| Rok vydání: | 2009 |
| Předmět: |
Adult
Male medicine.medical_specialty Cholagogues and Choleretics Cirrhosis medicine.drug_class medicine.medical_treatment Cholangitis Sclerosing Kaplan-Meier Estimate Liver transplantation digestive system Gastroenterology Article Primary sclerosing cholangitis Primary biliary cirrhosis Double-Blind Method Liver Function Tests Internal medicine medicine Humans Aspartate Aminotransferases Aged Hepatology Bile acid medicine.diagnostic_test business.industry Ursodeoxycholic Acid Bilirubin Middle Aged medicine.disease Alkaline Phosphatase Ursodeoxycholic acid Liver Transplantation Treatment Outcome Portal hypertension Female business Liver function tests medicine.drug |
| Popis: | Previous controlled trials are inconclusive regarding the efficacy of ursodeoxycholic acid (UDCA) for treating primary sclerosing cholangitis (PSC). One hundred fifty adult patients with PSC were enrolled in a long-term, randomized, double-blind controlled trial of high-dose UDCA (28-30 mg/kg/day) versus placebo. Liver biopsy and cholangiography were performed before randomization and after 5 years. The primary outcome measures were development of cirrhosis, varices, cholangiocarcinoma, liver transplantation, or death. The study was terminated after 6 years due to futility. At enrollment, the UDCA (n = 76) and placebo (n = 74) groups were similar with respect to sex, age, duration of disease, serum aspartate aminotransferase and alkaline phosphatase levels, liver histology, and Mayo risk score. During therapy, aspartate aminotransferase and alkaline phosphatase levels decreased more in the UDCA group than the placebo group (P0.01), but improvements in liver tests were not associated with decreased endpoints. By the end of the study, 30 patients in the UDCA group (39%) versus 19 patients in the placebo group (26%) had reached one of the pre-established clinical endpoints. After adjustment for baseline stratification characteristics, the risk of a primary endpoint was 2.3 times greater for patients on UDCA than for those on placebo (P0.01) and 2.1 times greater for death, transplantation, or minimal listing criteria (P = 0.038). Serious adverse events were more common in the UDCA group than the placebo group (63% versus 37% [P0.01]).Long-term, high-dose UDCA therapy is associated with improvement in serum liver tests in PSC but does not improve survival and was associated with higher rates of serious adverse events. |
| Databáze: | OpenAIRE |
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