PMID- 33751787 OWN - NLM STAT- MEDLINE DCOM- 20210625 LR - 20210625 IS - 1478-3231 (Electronic) IS - 1478-3223 (Linking) VI - 41 IP - 6 DP - 2021 Jun TI - Safety of fibrates in cholestatic liver diseases. PG - 1335-1343 LID - 10.1111/liv.14871 [doi] AB - BACKGROUND AND AIM: Off-label use of fibrates in patients with cholestatic liver diseases results in improved biochemical parameters and pruritus; however, their safety in this population has been a concern. This study summarizes safety data for fibrates when used for treatment of cholestatic liver diseases. METHODS: A systematic review of published studies evaluating the use of fibrates for treatment of primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC) was performed. Electronic databases were searched up to December 2019 for published studies evaluating treatment outcomes associated to fibrates for these 2 diseases. RESULTS: A total of 37 studies were identified, including 31 for PBC and 6 for PSC, with a total of 1107 unique patients treated with fibrates +/- ursodeoxycholic acid (UDCA). Most studies evaluated fenofibrate and bezafibrate, and only 1 study evaluated pemafibrate. There were no studies evaluating gemfibrozil or clofibrate. The most commonly reported adverse events (AEs) were gastrointestinal and musculoskeletal. Elevations of aminotransferases and serum creatinine were reported more commonly in patients treated with UDCA plus fibrates versus UDCA monotherapy. CONCLUSIONS: Fibrates appear to be safe and well tolerated in patients with PBC, with a low frequency of AEs. There are scarce data about the safety of these agents for treatment of PSC. CI - (c) 2021 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd. FAU - Carrion, Andres F AU - Carrion AF AUID- ORCID: 0000-0001-5805-6638 AD - Division of Gastroenterology and Hepatology, University of Miami, Miami, FL, USA. FAU - Lindor, Keith D AU - Lindor KD AUID- ORCID: 0000-0003-1046-5621 AD - Division of Gastroenterology and Hepatology, Mayo Clinic, Scottsdale, AZ, USA. AD - Office of University Provost, Arizona State University, Phoenix, AZ, USA. FAU - Levy, Cynthia AU - Levy C AUID- ORCID: 0000-0001-5498-6037 AD - Division of Gastroenterology and Hepatology, University of Miami, Miami, FL, USA. LA - eng PT - Journal Article PT - Systematic Review DEP - 20210318 PL - United States TA - Liver Int JT - Liver international : official journal of the International Association for the Study of the Liver JID - 101160857 RN - 0 (Cholagogues and Choleretics) RN - 0 (Fibric Acids) RN - 724L30Y2QR (Ursodeoxycholic Acid) RN - Y9449Q51XH (Bezafibrate) SB - IM MH - Bezafibrate/adverse effects MH - *Cholagogues and Choleretics/adverse effects MH - Fibric Acids/adverse effects MH - Humans MH - *Liver Cirrhosis, Biliary/drug therapy MH - Ursodeoxycholic Acid/adverse effects OTO - NOTNLM OT - bezafibrate OT - fenofibrate OT - fibrates OT - primary biliary cholangitis OT - primary sclerosing cholangitis EDAT- 2021/03/23 06:00 MHDA- 2021/06/29 06:00 CRDT- 2021/03/22 19:39 PHST- 2021/02/11 00:00 [revised] PHST- 2020/09/10 00:00 [received] PHST- 2021/03/01 00:00 [accepted] PHST- 2021/03/23 06:00 [pubmed] PHST- 2021/06/29 06:00 [medline] PHST- 2021/03/22 19:39 [entrez] AID - 10.1111/liv.14871 [doi] PST - ppublish SO - Liver Int. 2021 Jun;41(6):1335-1343. doi: 10.1111/liv.14871. Epub 2021 Mar 18.