Adjunctive fenofibrate therapy benefited patients with primary biliary cirrhosis

BOSTON — Fenofibrate was an effective adjunct therapy for the treatment of patients with primary biliary cirrhosis with lack of response to ursodeoxycholic acid, according to data presented at The Liver Meeting.

“There is clearly an unmet need for adjunct therapies for patients with [primary biliary cirrhosis] who don’t have a biochemical response to ursodeoxycholic acid,” Cynthia Levy, MD, of the division of hepatology at the University of Miami Miller School of Medicine, told Healio Gastroenterology. “While several novel molecules are currently under investigation, the fibrates are readily available worldwide. Many groups have published relatively small, uncontrolled studies and we wanted to analyze the combined pooled data.”

Cynthia Levy

Aiming to evaluate the efficacy of fenofibrate for treatment of primary biliary cirrhosis (PBC), researchers performed a systematic review and meta-analysis of relevant literature using electronic databases, and pooled data on changes in means of alkaline phosphatase, gamma-glutamyl transferase (GGT), bilirubin and IgM levels before and after treatment, as well as overall complete response rate to fenofibrate. Six studies with 102 patients (90% women) were included in the final analysis. All patients had no or incomplete response to ursodeoxycholic acid (UDCA) and therefore received additional 100-200 mg fenofibrate daily for 8-100 weeks.

Fenofibrate treatment was associated with decreased mean pooled alkaline phosphatase (–114 IU/L; 95% CI, –1.52 to –76), decreased GGT (–92 IU/L; 95% CI, –1.49 to –43), decreased bilirubin (–0.11 mg/dl; 95% CI, –0.18 to –0.08) and decreased IgM (–88 mg/dl; 95% CI, –119 to –58). There was 69% (95% CI, 53% to 82%) pooled complete response rate while receiving fenofibrate therapy (OR=2.43; 95% CI, 1.44-4.1).

“We confirmed that patients with incomplete response to UDCA who were treated with fenofibrate had improvement in serum alkaline phosphatase and serum bilirubin, two recognized surrogate prognostic markers in PBC,” Levy said. “Our results suggest that a larger randomized controlled study is certainly warranted and worth funding.” – by Adam Leitenberger

For more information:

Grigorian A. Abstract 290. Presented at: The Liver Meeting, Nov. 7-11, 2014; Boston, MA.

Disclosure: Levy is a consultant for Gilead, Lumena and Evidera.