Pilot study: fenofibrate for patients with primary biliary cirrhosis and an incomplete response to ursodeoxycholic acid
Aliment Pharmacol Ther 2011; 33: 235–242 Summary 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...
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| creator | 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, K. |
| description | Aliment Pharmacol Ther 2011; 33: 235–242
Summary
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 |
| doi_str_mv | 10.1111/j.1365-2036.2010.04512.x |
| format | Article |
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Summary
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.</description><identifier>ISSN: 0269-2813</identifier><identifier>EISSN: 1365-2036</identifier><identifier>DOI: 10.1111/j.1365-2036.2010.04512.x</identifier><identifier>PMID: 21083674</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>Adult ; Aged ; Biological and medical sciences ; Cholagogues and Choleretics - administration & dosage ; Cholagogues and Choleretics - adverse effects ; Digestive system ; Drug Therapy, Combination ; Female ; Fenofibrate - administration & dosage ; Fenofibrate - adverse effects ; Gastroenterology. Liver. Pancreas. Abdomen ; Humans ; Hypolipidemic Agents - administration & dosage ; Hypolipidemic Agents - adverse effects ; Liver Cirrhosis, Biliary - drug therapy ; Liver. Biliary tract. Portal circulation. Exocrine pancreas ; Male ; Medical sciences ; Middle Aged ; Other diseases. Semiology ; Pharmacology. Drug treatments ; Pilot Projects ; Statistics as Topic ; Treatment Outcome ; Ursodeoxycholic Acid - administration & dosage ; Ursodeoxycholic Acid - adverse effects</subject><ispartof>Alimentary pharmacology & therapeutics, 2011-01, Vol.33 (2), p.235-242</ispartof><rights>2010 Blackwell Publishing Ltd</rights><rights>2015 INIST-CNRS</rights><rights>2010 Blackwell Publishing Ltd.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3992-24ecf381f8aa8d7c872175ffa7ed05c1e4623f2bbea8c91fe1154504da63f0ec3</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fj.1365-2036.2010.04512.x$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fj.1365-2036.2010.04512.x$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,1427,27901,27902,45550,45551,46384,46808</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=23686625$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21083674$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Levy, C.</creatorcontrib><creatorcontrib>Peter, J. A.</creatorcontrib><creatorcontrib>Nelson, D. R.</creatorcontrib><creatorcontrib>Keach, J.</creatorcontrib><creatorcontrib>Petz, J.</creatorcontrib><creatorcontrib>Cabrera, R.</creatorcontrib><creatorcontrib>Clark, V.</creatorcontrib><creatorcontrib>Firpi, R. J.</creatorcontrib><creatorcontrib>Morelli, G.</creatorcontrib><creatorcontrib>Soldevila‐Pico, C.</creatorcontrib><creatorcontrib>Lindor, K.</creatorcontrib><title>Pilot study: fenofibrate for patients with primary biliary cirrhosis and an incomplete response to ursodeoxycholic acid</title><title>Alimentary pharmacology & therapeutics</title><addtitle>Aliment Pharmacol Ther</addtitle><description>Aliment Pharmacol Ther 2011; 33: 235–242
Summary
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.</description><subject>Adult</subject><subject>Aged</subject><subject>Biological and medical sciences</subject><subject>Cholagogues and Choleretics - administration & dosage</subject><subject>Cholagogues and Choleretics - adverse effects</subject><subject>Digestive system</subject><subject>Drug Therapy, Combination</subject><subject>Female</subject><subject>Fenofibrate - administration & dosage</subject><subject>Fenofibrate - adverse effects</subject><subject>Gastroenterology. Liver. Pancreas. Abdomen</subject><subject>Humans</subject><subject>Hypolipidemic Agents - administration & dosage</subject><subject>Hypolipidemic Agents - adverse effects</subject><subject>Liver Cirrhosis, Biliary - drug therapy</subject><subject>Liver. Biliary tract. Portal circulation. Exocrine pancreas</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Other diseases. Semiology</subject><subject>Pharmacology. Drug treatments</subject><subject>Pilot Projects</subject><subject>Statistics as Topic</subject><subject>Treatment Outcome</subject><subject>Ursodeoxycholic Acid - administration & dosage</subject><subject>Ursodeoxycholic Acid - adverse effects</subject><issn>0269-2813</issn><issn>1365-2036</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpFkUtLxDAQgIMouj7-guQinrrm0aZZwYOILxDcw3oOaTphs2SbmrTs7r-31VUDYcLMNwOZDyFMyZQO52Y1pVwUGSNcTBkZsiQvKJtuD9Dkr3CIJoSJWcYk5SfoNKUVIUSUhB2jE0aJ5KLMJ2gzdz50OHV9vbvFFppgXRV1B9iGiFvdOWi6hDeuW-I2urWOO1w578ZoXIzLkFzCuqmHi11jwrr1MHRHSG1oEuAu4D6mUEPY7swyeGewNq4-R0dW-wQX-3iGPp4eFw8v2dv78-vD_Vtm-GzGMpaDsVxSK7WWdWlkyWhZWKtLqElhKOSCccuqCrQ0M2qB0iIvSF5rwS0Bw8_Q9c_cNobPHlKn1i4Z8F43EPqkJJU54bJgA3m5J_tqDbXa_1b97moArvaATkZ7G3VjXPrnuJBCsGLg7n64jfOw-6tTokZ3aqVGRWpUpEZ36tud2qr7-WJ88S-jJY81</recordid><startdate>201101</startdate><enddate>201101</enddate><creator>Levy, C.</creator><creator>Peter, J. A.</creator><creator>Nelson, D. R.</creator><creator>Keach, J.</creator><creator>Petz, J.</creator><creator>Cabrera, R.</creator><creator>Clark, V.</creator><creator>Firpi, R. J.</creator><creator>Morelli, G.</creator><creator>Soldevila‐Pico, C.</creator><creator>Lindor, K.</creator><general>Blackwell Publishing Ltd</general><general>Blackwell</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7X8</scope></search><sort><creationdate>201101</creationdate><title>Pilot study: fenofibrate for patients with primary biliary cirrhosis and an incomplete response to ursodeoxycholic acid</title><author>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, K.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3992-24ecf381f8aa8d7c872175ffa7ed05c1e4623f2bbea8c91fe1154504da63f0ec3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Biological and medical sciences</topic><topic>Cholagogues and Choleretics - administration & dosage</topic><topic>Cholagogues and Choleretics - adverse effects</topic><topic>Digestive system</topic><topic>Drug Therapy, Combination</topic><topic>Female</topic><topic>Fenofibrate - administration & dosage</topic><topic>Fenofibrate - adverse effects</topic><topic>Gastroenterology. Liver. Pancreas. Abdomen</topic><topic>Humans</topic><topic>Hypolipidemic Agents - administration & dosage</topic><topic>Hypolipidemic Agents - adverse effects</topic><topic>Liver Cirrhosis, Biliary - drug therapy</topic><topic>Liver. Biliary tract. Portal circulation. Exocrine pancreas</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Other diseases. Semiology</topic><topic>Pharmacology. Drug treatments</topic><topic>Pilot Projects</topic><topic>Statistics as Topic</topic><topic>Treatment Outcome</topic><topic>Ursodeoxycholic Acid - administration & dosage</topic><topic>Ursodeoxycholic Acid - adverse effects</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Levy, C.</creatorcontrib><creatorcontrib>Peter, J. A.</creatorcontrib><creatorcontrib>Nelson, D. R.</creatorcontrib><creatorcontrib>Keach, J.</creatorcontrib><creatorcontrib>Petz, J.</creatorcontrib><creatorcontrib>Cabrera, R.</creatorcontrib><creatorcontrib>Clark, V.</creatorcontrib><creatorcontrib>Firpi, R. J.</creatorcontrib><creatorcontrib>Morelli, G.</creatorcontrib><creatorcontrib>Soldevila‐Pico, C.</creatorcontrib><creatorcontrib>Lindor, K.</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>MEDLINE - Academic</collection><jtitle>Alimentary pharmacology & therapeutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Levy, C.</au><au>Peter, J. A.</au><au>Nelson, D. R.</au><au>Keach, J.</au><au>Petz, J.</au><au>Cabrera, R.</au><au>Clark, V.</au><au>Firpi, R. J.</au><au>Morelli, G.</au><au>Soldevila‐Pico, C.</au><au>Lindor, K.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Pilot study: fenofibrate for patients with primary biliary cirrhosis and an incomplete response to ursodeoxycholic acid</atitle><jtitle>Alimentary pharmacology & therapeutics</jtitle><addtitle>Aliment Pharmacol Ther</addtitle><date>2011-01</date><risdate>2011</risdate><volume>33</volume><issue>2</issue><spage>235</spage><epage>242</epage><pages>235-242</pages><issn>0269-2813</issn><eissn>1365-2036</eissn><abstract>Aliment Pharmacol Ther 2011; 33: 235–242
Summary
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.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>21083674</pmid><doi>10.1111/j.1365-2036.2010.04512.x</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adult Aged Biological and medical sciences Cholagogues and Choleretics - administration & dosage Cholagogues and Choleretics - adverse effects Digestive system Drug Therapy, Combination Female Fenofibrate - administration & dosage Fenofibrate - adverse effects Gastroenterology. Liver. Pancreas. Abdomen Humans Hypolipidemic Agents - administration & dosage Hypolipidemic Agents - adverse effects Liver Cirrhosis, Biliary - drug therapy Liver. Biliary tract. Portal circulation. Exocrine pancreas Male Medical sciences Middle Aged Other diseases. Semiology Pharmacology. Drug treatments Pilot Projects Statistics as Topic Treatment Outcome Ursodeoxycholic Acid - administration & dosage Ursodeoxycholic Acid - adverse effects |
| title | Pilot study: fenofibrate for patients with primary biliary cirrhosis and an incomplete response to ursodeoxycholic acid |
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