| Pilot study: fenofibrate for patients with primary biliary cirrhosis and an incomplete response to ursodeoxycholic acid. | |
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MedLine Citation:
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PMID: 21083674 Owner: NLM Status: In-Process |
Abstract/OtherAbstract:
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BACKGROUND: Newer therapies are needed for patients with primary biliary cirrhosis and incomplete response to ursodeoxycholic acid (UDCA). Fenofibrate is a fibric acid postulated to regulate immune response and cell proliferation. AIM: To evaluate the efficacy and safety of fenofibrate in patients with primary biliary cirrhosis and incomplete response to UDCA. METHODS: We undertook a pilot study involving 20 patients with primary biliary cirrhosis and serum alkaline phosphatase (ALP) ≥ 2× ULN. Nonparametric statistical tests and Spearman correlation test were used as appropriate. RESULTS: Twenty patients received fenofibrate (160 mg/day) in addition to UDCA for 48 weeks. Median serum ALP decreased significantly at 48 weeks compared with baseline values [351 (214-779) U/L at baseline vs. 177 (60-384) U/L at 48 weeks, P < 0.05]. A rebound in ALP occurred upon drug discontinuation. Serum aspartate aminotransferase and Immunoglobulin M also decreased significantly, while bilirubin and albumin remained unchanged. Median IL-1 decreased from 28.9 (2.7-10 000) to 11.3 (2.5-277.7) pg/mL (P = 0.049), and median IL-6 from 4.6 (3.2-5205) to 3.5 (3.2-73.4) pg/mL (P = 0.027). Heartburn was the most frequent adverse event, leading to discontinuation of two study subjects. CONCLUSIONS: Combination therapy of fenofibrate and UDCA induced significant biochemical improvement in patients with primary biliary cirrhosis and incomplete response to UDCA. Further studies are warranted. |
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Authors:
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C Levy; J A Peter; D R Nelson; J Keach; J Petz; R Cabrera; V Clark; R J Firpi; G Morelli; C Soldevila-Pico; K Lindor |
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Publication Detail:
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Type: Journal Article; Research Support, Non-U.S. Gov't Date: 2010-11-17 |
Journal Detail:
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Title: Alimentary pharmacology & therapeutics Volume: 33 ISSN: 1365-2036 ISO Abbreviation: Aliment. Pharmacol. Ther. Publication Date: 2011 Jan |
Date Detail:
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Created Date: 2010-12-15 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8707234 Medline TA: Aliment Pharmacol Ther Country: England |
Other Details:
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Languages: eng Pagination: 235-42 Citation Subset: IM |
Copyright Information:
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© 2010 Blackwell Publishing Ltd. |
Affiliation:
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Department of Medicine, University of Florida, Gainesville, USA. clevy@med.miami.edu |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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