Effects of pemafibrate on primary biliary cholangitis with dyslipidemia.

Abstract

The purpose of this study was to examine the effect of pemafibrate (PEM) in primary biliary cholangitis (PBC) patients with dyslipidemia. Patients who were diagnosed with PBC between June 2018 and December 31, 2020 were included in the study if they also had dyslipidemia and their alkaline phosphatase (ALP) or gamma-glutamyl transferase (GGT) levels remained above the normal range despite taking 600mg/day ursodeoxycholic acid (UDCA) for at least 6months. Patients who were treated with UDCA alonewere administered PEM as an add-on (PEM-add group), and patients whowere treated with UDCA and bezafibrate (BEZ) for at least 6months weregiven PEM instead of BEZ (PEM-switch group). Clinical parameters werecompared in all patients, and the levels of ALP, GGT, the estimated glomerular filtration rate (eGFR), and creatinine (Cr) were compared between thePEM-add and PEM-switch groups. Improvement in cholangitis was also evaluated. In the PEM-add group, both ALP and GGT improved in 40 of 46 patients (87.0%). In the PEM-switch group, both ALP and GGT improved in 15 of 29 patients (51.7%). In the PEM-switch group, however, significant improvement was seen in eGFR and Cr. Administration of PEM is effective in PBC patients with dyslipidemia who are refractory to UDCA monotherapy. In patients using both UDCA and BEZ, there was an advantage in switching to PEM if they had renal damage; however, improvement of ALP and GGT occurred in about 50%.