Cholesterol-lowering medications known as fibrates, often used off-label to treat primary biliary cholangitis (PBC) , demonstrate statistically significant reductions in cholestatic surrogate markers (defined as markers of impaired bile flow; i.e., alkaline phosphatase and bilirubin levels) after one year of administration, according to the results of a Dutch real-world analysis presented at the American Association for the Study of Liver Diseases (AASLD) Liver Meeting.
“About a third of patients reached the most stringent biochemical treatment goals,” the researchers, led by Maria C. Van Hooff, M.D. from Erasmus University Medical Center in Rotterdam, The Netherlands, added. “However, the discontinuation rate was high, indicating the need to optimize fibrate treatment strategies.”
The researchers focused on 318 patients, with a median age of 55.3 years, from the Dutch PBC cohort study who initiated treatment with fibrates (bezafibrate: 97.8%; ciprofibrate: 1.6%; gemfibrozil: 0.6%) during follow-up. At baseline, the median alkaline phosphatase and bilirubin levels were 2.42 and 0.55 times the upper limit of normal, respectively. A total of 14.2% of patients had cirrhosis.
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Nearly a quarter of patients (21.1%) discontinued fibrate therapy within the first year. The researchers noted that 19.8% of the study population had not yet reached nine months of treatment.
The change in alkaline phosphatase and bilirubin was evaluable in 165 and 148 patients, respectively, according to the researchers. Overall, the median change in alkaline phosphatase was -1.03, and the median change in bilirubin was -0.08.
For patients with a baseline alkaline phosphatase level of up to 1.67 times the upper limit of normal, the median change was -0.58; the researchers reported a median change of -1.33 for those with a higher baseline level.
There was no change in the median bilirubin for patients who had a baseline level of up to 0.6 times the upper limit of normal, whereas those with a higher baseline level demonstrated a median change of -0.17.
Slightly fewer than a third of patients (31.0%) with elevated baseline alkaline phosphatase levels reached normalization by 12 months. A total of 27.4% of those with a baseline bilirubin level of more than 0.6 times the upper limit of normal were below this threshold.
