Long-term treatment with fenofibrate may offer sustained benefits for people living with primary biliary cholangitis (PBC) who do not fully respond to standard treatment, according to new research published in Alimentary Pharmacology & Therapeutics.
While ursodeoxycholic acid (UDCA) remains the first-line therapy for PBC, up to 40% of patients do not fully respond to the treatment. This leaves them at higher risk of disease progression.
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In the new study, researchers reviewed the records of 59 individuals treated at a single academic medical center who were given fenofibrate in addition to UDCA because their alkaline phosphatase (ALP), a key marker of bile duct injury, remained elevated. Researchers followed the study participants for an average of 45 months.
The results showed steady and significant improvements. The median time to normalization of ALP was about 9.5 months. After one year, nearly 58% of patients had normal ALP levels. By four years, that figure rose to about 85% among those still being followed.
The study also showed improvements among people who had not met established response criteria before starting fenofibrate. This group achieved ALP normalization in a median time of 11.2 months.
Fenofibrate, a peroxisome proliferator-activated receptor alpha (PPAR-ɑ) agonist, is approved to treat high cholesterol and high triglycerides, but is sometimes used off-label in PBC. The medication was generally well tolerated. Fifteen participants discontinued therapy, with 5% stopping due to worsening liver enzymes.
It’s important to note that because this was a retrospective study at a single center, it cannot prove cause and effect. Still, the researchers say that the findings provide encouraging data supporting fenofibrate as a potential second-line option for people with PBC who do not respond fully to standard therapy.
“In this long-term cohort of PBC patients with insufficient response to UDCA, fenofibrate significantly improved cholestatic markers and prognostic scores over time,” the study authors concluded. “Given this, and its favourable safety profile, fenofibrate should be further considered as an accessible and affordable second-line therapy in PBC.”
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