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PPAR Agonist Improves Pruritus in Patients With Cholestatic Diseases

A recent study found bezafibrate, a broad peroxisome proliferator-activated receptor (PPAR) agonist, was superior to placebo at improving moderate to severe pruritus among patients with cholestatic diseases.

Pruritus can seriously impair quality of life among patients with cholestatic diseases, but pharmacological strategies have shown limited efficacy in treating itch.

In a recent randomized placebo-controlled study, the researchers assessed the efficacy of bezafibrate on pruritus among patients with primary sclerosing cholangitis (PSC), primary biliary cholangitis (PBC), and secondary sclerosing cholangitis (SCC) and moderate to severe pruritus. Participants were treated with once daily bezafibrate 400 mg or placebo for 21 days. The primary endpoint was the proportion of participants achieving a greater than 50% reduction in the pruritus based on a visual analogue scale.

A total of 70 participants completed the trial: 44 with PSC, 24 with PBC, and 2 with SCC.

Compared with placebo, bezafibrate was associated with a greater than 50% reduction in pruritus (11% vs 45%, respectively), with 55% of patients with PBC and 41% with PSC treated with the therapy achieving the primary endpoint.

The researchers also found bezafibrate reduced morning and evening intensity of pruritus compared with placebo, as well as improved scores on the validated 5-D itch questionnaire.

In addition, bezafibrate reduced serum alkaline phosphatase, which correlated with improved pruritus and suggested reduced biliary damage, the researchers wrote. While serum bile acids and autotaxin activity remained unchanged, serum creatinine levels mildly increased, they added.

“Bezafibrate is superior to placebo in improving moderate to severe pruritus in patients with PSC and PBC,” the researchers concluded.


de Vries E, Bolier R, Goet J, et al. Fibrates for itch (FITCH) in fibrosing cholangiopathies: a double blind, randomized, placebo-controlled trial. J Am Acad Dermatol. Published online October 5, 2020. doi:10.1053/j.gastro.2020.10.001

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