Fenofibrate/UDCA improve outcomes in PBC vs. UDCA alone
Fenofibrate in combination with ursodeoxycholic acid was found to be associated with transplant-free survival, improved alkaline phosphatase and other outcomes in patients with primary biliary cholangitis who failed to respond to ursodeoxycholic acid monotherapy.
Researchers, including A.C. Cheung, MD, FRCP, and Jordan J. Feld, MD, both from the Toronto Western Hospital Liver Centre, and colleagues, conducted a retrospective cohort study with 120 patients with primary biliary cholangitis treated with ursodeoxycholic acid (UDCA) alone (n = 74) or fenofibrates in combination with UDCA (n = 46) between August 1989 and July 2014. All patients received a dose of 13 to 15 mg/kg per day of UDCA. Patients in the fenofibrate group were prescribed 145 mg of Lipidil EZ (BGP Pharma ULC, Canada) daily for a median of 11 months following incomplete response with UDCA alone.
Among patients in the fenofibrate group, 41% had alkaline phosphatase (ALP) levels less than 1.67 times the upper limit of normal, according to Toronto criteria for biochemical response, compared with 7% of patients in the UDCA alone group (P = .0001).
Patients in the fenofibrate group also had lower alanine aminotransferase (P = .01) and aspartate aminotransferase (P = .05) levels over time compared with baseline.
Fenofibrate was associated with improved decompensation-free and transplant-free survival (HR = 0.09; 95% CI, 0.03-0.32). However, according to multivariate analysis, the use of fenofibrates was independently associated with improved outcomes, not biochemical response (HR = 0.4; 95% CI, 0.17-0.93).
Fifteen-percent of patients discontinued fenofibrate treatment due to adverse events, of which the most common were abdominal pain and myalgias. Patients in the fenofibrate group with cirrhosis showed increased mean bilirubin over time (P = .005).
“Fenofibrate appears to be well-tolerated in the majority of patients, with no clear association between the frequency of self-reported medication side effects and the stage of fibrosis,” the researchers concluded. “While patients with cirrhosis may also benefit from fibrate therapy, they should be monitored closely upon treatment initiation as patients may decompensate despite achieving improvements in ALP.” – by Melinda Stevens
Disclosure: The researchers report no relevant financial disclosures.