Efficacy and safety of fenofibrate add-on therapy for patients with primary biliary cholangitis and a suboptimal response to UDCA
ABSTRACT Background: primary biliary cholangitis (PBC) patients with a suboptimal response to ursodeoxycholic acid (UDCA) have a significantly worse survival rate. Fenofibrate has been shown to improve the short-term biochemical response in this group of patients. However, there is limited data av...
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| Format: | Article |
| Language: | English |
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Aran Ediciones
2018-09-01
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| Series: | Revista Espanola de Enfermedades Digestivas |
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| Online Access: | http://scielo.isciii.es/scielo.php?script=sci_arttext&pid=S1130-01082018000900005&tlng=en |
| _version_ | 1798021890859597824 |
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| author | Weijia Duan Xiaojuan Ou Xiaoming Wang Yu Wang Xinyan Zhao Qianyi Wang Xiaoning Wu Wei Zhang Hong Ma Hong You Jidong Jia |
| author_facet | Weijia Duan Xiaojuan Ou Xiaoming Wang Yu Wang Xinyan Zhao Qianyi Wang Xiaoning Wu Wei Zhang Hong Ma Hong You Jidong Jia |
| author_sort | Weijia Duan |
| collection | DOAJ |
| description | ABSTRACT Background: primary biliary cholangitis (PBC) patients with a suboptimal response to ursodeoxycholic acid (UDCA) have a significantly worse survival rate. Fenofibrate has been shown to improve the short-term biochemical response in this group of patients. However, there is limited data available on the safety and efficacy of its long-term use, especially in patients with cirrhosis. Methods: in this retrospective cohort study, fenofibrate was given to PBC patients with a suboptimal response to at least 12 months of UDCA (13-15 mg/kg/d) therapy. Biochemistry data, GLOBE score and UK-PBC risk score at baseline and at different time points of treatment were compared. The safety profiles were also compared between cirrhotic and non-cirrhotic patient groups. Results: fenofibrate (200 mg/day) was given to 39 PBC patients with a suboptimal response to UDCA (15 cirrhotic and 24 non-cirrhotic patients). In the 26 patients who completed more than one year of combination therapy, the alkaline phosphatase (ALP) levels were 215 (185, 326) U/l, 122 (110, 202) U/l, 128 (106, 194) U/l, 124 (100, 181) U/l and 120 (82, 168) U/l, at baseline, three months, six months, 12 months and 24 months, respectively. All p values were < 0.01 when compared to baseline values. After two years of combination therapy, the UK-PBC risk score and GLOBE score did not significantly improve. The overall rates of adverse events were not significantly different between the cirrhotic and non-cirrhotic group. The elevation of liver enzymes was the most frequent side effect (n = 7), leading to a discontinuation in four patients. Furthermore, after two years of combination therapy, the serum creatinine levels and estimated glomerular filtration rates (eGFR) were significantly worse in both groups. Conclusion: fenofibrate add-on therapy could improve ALP and -GT levels in both non-cirrhotic and cirrhotic PBC patients with a suboptimal response to UDCA. However, patients need to be monitored carefully for a potential liver injury and nephrotoxicity. |
| first_indexed | 2024-04-11T17:20:52Z |
| format | Article |
| id | doaj.art-018a8b0bc1664f56bc232124afffa9e2 |
| institution | Directory Open Access Journal |
| issn | 1130-0108 |
| language | English |
| last_indexed | 2024-04-11T17:20:52Z |
| publishDate | 2018-09-01 |
| publisher | Aran Ediciones |
| record_format | Article |
| series | Revista Espanola de Enfermedades Digestivas |
| spelling | doaj.art-018a8b0bc1664f56bc232124afffa9e22022-12-22T04:12:29ZengAran EdicionesRevista Espanola de Enfermedades Digestivas1130-01082018-09-01110955756310.17235/reed.2018.5533/2018Efficacy and safety of fenofibrate add-on therapy for patients with primary biliary cholangitis and a suboptimal response to UDCAWeijia DuanXiaojuan OuXiaoming WangYu WangXinyan ZhaoQianyi WangXiaoning WuWei ZhangHong MaHong YouJidong JiaABSTRACT Background: primary biliary cholangitis (PBC) patients with a suboptimal response to ursodeoxycholic acid (UDCA) have a significantly worse survival rate. Fenofibrate has been shown to improve the short-term biochemical response in this group of patients. However, there is limited data available on the safety and efficacy of its long-term use, especially in patients with cirrhosis. Methods: in this retrospective cohort study, fenofibrate was given to PBC patients with a suboptimal response to at least 12 months of UDCA (13-15 mg/kg/d) therapy. Biochemistry data, GLOBE score and UK-PBC risk score at baseline and at different time points of treatment were compared. The safety profiles were also compared between cirrhotic and non-cirrhotic patient groups. Results: fenofibrate (200 mg/day) was given to 39 PBC patients with a suboptimal response to UDCA (15 cirrhotic and 24 non-cirrhotic patients). In the 26 patients who completed more than one year of combination therapy, the alkaline phosphatase (ALP) levels were 215 (185, 326) U/l, 122 (110, 202) U/l, 128 (106, 194) U/l, 124 (100, 181) U/l and 120 (82, 168) U/l, at baseline, three months, six months, 12 months and 24 months, respectively. All p values were < 0.01 when compared to baseline values. After two years of combination therapy, the UK-PBC risk score and GLOBE score did not significantly improve. The overall rates of adverse events were not significantly different between the cirrhotic and non-cirrhotic group. The elevation of liver enzymes was the most frequent side effect (n = 7), leading to a discontinuation in four patients. Furthermore, after two years of combination therapy, the serum creatinine levels and estimated glomerular filtration rates (eGFR) were significantly worse in both groups. Conclusion: fenofibrate add-on therapy could improve ALP and -GT levels in both non-cirrhotic and cirrhotic PBC patients with a suboptimal response to UDCA. However, patients need to be monitored carefully for a potential liver injury and nephrotoxicity.http://scielo.isciii.es/scielo.php?script=sci_arttext&pid=S1130-01082018000900005&tlng=enPrimary biliary cholangitisFenofibrateUrsodeoxycholic acid |
| spellingShingle | Weijia Duan Xiaojuan Ou Xiaoming Wang Yu Wang Xinyan Zhao Qianyi Wang Xiaoning Wu Wei Zhang Hong Ma Hong You Jidong Jia Efficacy and safety of fenofibrate add-on therapy for patients with primary biliary cholangitis and a suboptimal response to UDCA Revista Espanola de Enfermedades Digestivas Primary biliary cholangitis Fenofibrate Ursodeoxycholic acid |
| title | Efficacy and safety of fenofibrate add-on therapy for patients with primary biliary cholangitis and a suboptimal response to UDCA |
| title_full | Efficacy and safety of fenofibrate add-on therapy for patients with primary biliary cholangitis and a suboptimal response to UDCA |
| title_fullStr | Efficacy and safety of fenofibrate add-on therapy for patients with primary biliary cholangitis and a suboptimal response to UDCA |
| title_full_unstemmed | Efficacy and safety of fenofibrate add-on therapy for patients with primary biliary cholangitis and a suboptimal response to UDCA |
| title_short | Efficacy and safety of fenofibrate add-on therapy for patients with primary biliary cholangitis and a suboptimal response to UDCA |
| title_sort | efficacy and safety of fenofibrate add on therapy for patients with primary biliary cholangitis and a suboptimal response to udca |
| topic | Primary biliary cholangitis Fenofibrate Ursodeoxycholic acid |
| url | http://scielo.isciii.es/scielo.php?script=sci_arttext&pid=S1130-01082018000900005&tlng=en |
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