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Related Concept Videos

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Drugs for Treatment of Ulcerative Colitis in IBD

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Related Experiment Videos

Bezafibrate for primary biliary cirrhosis.

Jelena S Rudic1, Goran Poropat, Miodrag N Krstic

  • 1Department of Hepatology, Clinic of Gastroenterology, Clinical Centre of Serbia, Belgrade, Serbia. jelena_rudic@yahoo.com.

The Cochrane Database of Systematic Reviews
|January 20, 2012
PubMed
Summary

This review found bezafibrate did not significantly impact mortality or adverse events in primary biliary cirrhosis patients. While it may improve some liver biochemistry, more high-quality trials are needed to confirm bezafibrate

Related Experiment Videos

Area of Science:

  • Hepatology and Gastroenterology
  • Clinical Pharmacology
  • Evidence-Based Medicine

Background:

  • Primary biliary cirrhosis (PBC) treatment presents challenges.
  • Bezafibrate, alone or with ursodeoxycholic acid (UDCA), shows potential efficacy in PBC.
  • A comprehensive systematic review of bezafibrate's effects in PBC is currently lacking.

Purpose of the Study:

  • To systematically evaluate the beneficial and harmful effects of bezafibrate in patients diagnosed with primary biliary cirrhosis.
  • To synthesize evidence from randomized clinical trials comparing bezafibrate with placebo, no intervention, or other drugs.

Main Methods:

  • Searched multiple databases (Cochrane, MEDLINE, EMBASE, etc.) up to November 2011 for relevant randomized clinical trials.
  • Included trials compared bezafibrate (any dose/regimen) against placebo, no intervention, or another drug in PBC patients.
  • Data extraction and statistical analysis (risk ratios, mean differences) were performed, with risk of bias and trial sequential analyses conducted.

Main Results:

  • Six trials with 151 Japanese patients were included, all with a high risk of bias.
  • Bezafibrate showed no significant effect on adverse events compared to no intervention or UDCA.
  • Bezafibrate significantly decreased serum alkaline phosphatase activity versus no intervention and UDCA; effects on other liver enzymes and bilirubin were less conclusive or not supported by trial sequential analysis.

Conclusions:

  • The current evidence does not support bezafibrate's efficacy in improving mortality, liver-related morbidity, or adverse events in primary biliary cirrhosis.
  • Observed improvements in some liver biochemistry markers require cautious interpretation due to high risk of bias and potential for random errors.
  • Further high-quality randomized clinical trials with rigorous methodology are essential to definitively assess bezafibrate's role in PBC management.