Table 2.

Studies of Fenofibrate in PBC Patients

Study	Study Design	Inclusion Criteria	Study Duration and Number of Patients	Dose	Main Results
Han et al41	Prospective case series	PBC patients treated with UDCA for at least 1 year	3-6 months; 22 patients	Fenofibrate 200 mg/d	Decrease in ALP, GGT, AST, cholesterol, and TG; no significant effect on serum bilirubin
Levy et al43	Pilot study	PBC patients with ALP > 2 × ULN	12 months; 20 patients	Fenofibrate 160 mg/d	Decrease in ALP, AST, IgM, IL-1, and IL-6; no significant decrease in bilirubin
Liberopoulos et al45	Pilot study	PBC patients with incomplete biochemical response to UDCA for ≥8 months	2 months; 10 patients	Fenofibrate 200 mg/d	Decrease in ALP, GGT, ALT, cholesterol, TG, and HDL; fenofibrate was well tolerated
Walker et al46	Retrospective analysis of UK cohort	PBC patients with lack of response to UDCA	23 months; 16 patients	Fenofibrate 134-200 mg/d	Decrease in ALP (89% of patients had normalization of ALP) and IgM
Dohmen et al53	Prospective case series	PBC patients with lack of response to UDCA	3 months; 9 patients	Fenofibrate 100 or 150 mg/d	Decrease in ALP, GGT, and IgM; AMAs decreased in 4 patients; no adverse events noted
Ohira et al55	Prospective case series	Biopsy-proven PBC with lack of response to UDCA	6 months; 7 patients	Fenofibrate 150-200 mg/d	Decrease in ALP, GGT, and IgM
Nakamuta et al50	Prospective case series	Biopsy-proven PBC with prior UDCA treatment	25-53 months; 5 patients	Bezafibrate 400 mg/d, fenofibrate 150 mg/d	Decrease in ALP, GGT, ALT, IgM, and TG

ALP, alkaline phosphatase; ALT, alanine aminotransferase; AMAs, antimitochondrial antibodies; AST, aspartate aminotransferase; GGT, γ-glutamyl transferase; HDL, high-density lipoprotein; Ig, immunoglobulin; IL, interleukin; PBC, primary biliary cholangitis; TG, triglyceride; UDCA, ursodeoxycholic acid; UK, United Kingdom; ULN, upper limit of normal.