Año 2018 / Volumen 110 / Número 9
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Año 2018 / Volumen 110 / Número 9

Original

Efficacy and safety of fenofibrate add-on therapy for patients with primary biliary cholangitis and a suboptimal response to UDCA

557-563

Weijia Duan, Xiaojuan Ou, Xiaoming Wang, Yu Wang, Xinyan Zhao, Qianyi Wang, Xiaoning Wu, Wei Zhang, Hong Ma, Hong You, Jidong Jia,

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 γ-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.

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Asociación Española de Ecografía Digestiva Sociedad Española de Endoscopia Digestiva Sociedad Española de Patología Digestiva
La REED es el órgano oficial de la Sociedad Española de Patología Digestiva, la Sociedad
Española de Endoscopia Digestiva y la Asociación Española de Ecografía Digestiva
© 2018 Revista Española de Enfermedades Digestivas