Pilot study: Fenofibrate for patients with primary biliary cirrhosis and an incomplete response to ursodeoxycholic acid

C. Levy, J. A. Peter, D. R. Nelson, J. Keach, J. Petz, R. Cabrera, V. Clark, R. J. Firpi, G. Morelli, C. Soldevila-Pico, Keith Lindor

Research output: Contribution to journalArticle

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Abstract

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.

Original languageEnglish (US)
Pages (from-to)235-242
Number of pages8
JournalAlimentary Pharmacology and Therapeutics
Volume33
Issue number2
DOIs
StatePublished - Jan 2011
Externally publishedYes

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Fenofibrate
Ursodeoxycholic Acid
Biliary Liver Cirrhosis
Alkaline Phosphatase
Serum
Heartburn
Aspartate Aminotransferases
Interleukin-1
Bilirubin
Immunoglobulin M
Albumins
Interleukin-6
Cell Proliferation
Safety
Therapeutics
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Pharmacology (medical)

Cite this

Pilot study : Fenofibrate for patients with primary biliary cirrhosis and an incomplete response to ursodeoxycholic acid. / Levy, C.; Peter, J. A.; Nelson, D. R.; Keach, J.; Petz, J.; Cabrera, R.; Clark, V.; Firpi, R. J.; Morelli, G.; Soldevila-Pico, C.; Lindor, Keith.

In: Alimentary Pharmacology and Therapeutics, Vol. 33, No. 2, 01.2011, p. 235-242.

Research output: Contribution to journalArticle

Levy, C, Peter, JA, Nelson, DR, Keach, J, Petz, J, Cabrera, R, Clark, V, Firpi, RJ, Morelli, G, Soldevila-Pico, C & Lindor, K 2011, 'Pilot study: Fenofibrate for patients with primary biliary cirrhosis and an incomplete response to ursodeoxycholic acid', Alimentary Pharmacology and Therapeutics, vol. 33, no. 2, pp. 235-242. https://doi.org/10.1111/j.1365-2036.2010.04512.x
Levy, C. ; Peter, J. A. ; Nelson, D. R. ; Keach, J. ; Petz, J. ; Cabrera, R. ; Clark, V. ; Firpi, R. J. ; Morelli, G. ; Soldevila-Pico, C. ; Lindor, Keith. / Pilot study : Fenofibrate for patients with primary biliary cirrhosis and an incomplete response to ursodeoxycholic acid. In: Alimentary Pharmacology and Therapeutics. 2011 ; Vol. 33, No. 2. pp. 235-242.
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T2 - Fenofibrate for patients with primary biliary cirrhosis and an incomplete response to ursodeoxycholic acid

AU - Levy, C.

AU - Peter, J. A.

AU - Nelson, D. R.

AU - Keach, J.

AU - Petz, J.

AU - Cabrera, R.

AU - Clark, V.

AU - Firpi, R. J.

AU - Morelli, G.

AU - Soldevila-Pico, C.

AU - Lindor, Keith

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N2 - 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.

AB - 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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