- Bezafibrate, a peroxisome proliferator-activated receptor agonist, is more effective than placebo for improving pruritus (itch) in chronic cholestatic liver diseases, including primary sclerosing cholangitis (PSC), secondary sclerosing cholangitis (SSC), and primary biliary cholangitis (PBC).
Why this matters
- In patients with cholestatic liver disease, pruritus can negatively affect QoL.
- The study consisted of 44 patients with PSC, 2 patients with SSC, and 24 patients with PBC.
- Patients who reported an itch intensity of ≥5 out of 10 on a visual analogue scale were randomly assigned to either once-daily bezafibrate 400 mg (n=27) or placebo (n=33) for 21 days.
- Primary endpoint: 50% reduction of pruritus.
- Funding: None reported.
- A higher proportion of patients treated with bezafibrate experienced a ≥50% reduction in pruritus (38%) compared with patients treated with placebo (12%) (P=.03).
- Compared with placebo, bezafibrate-treated patients reported a greater reduction in the median morning pruritus intensity (P=.01) and evening pruritus intensity (P<.01>
- A more positive change in pruritus direction was observed with bezafibrate than placebo, according to the 5-D pruritus questionnaire (P<.001>
- There was a 36% reduction in serum alkaline phosphatase with bezafibrate but not with placebo (P=.04).
- Small sample size.