Evidence map›Paper›PMID 22911624›Full record

ArticleHepatology (Baltimore, Md.)2013

Anticholestatic effects of bezafibrate in patients with primary biliary cirrhosis treated with ursodeoxycholic acid.

Akira Honda, Tadashi Ikegami, Makoto Nakamuta, Teruo Miyazaki, Junichi Iwamoto, Takeshi Hirayama, Yoshifumi Saito, Hajime Takikawa, Michio Imawari, Yasushi Matsuzaki

Registry-linked trialOpen access · bronzeAbstract readControlled Clinical Trial
PubMed Publisher
In one paragraph

Article in Hepatology (Baltimore, Md.), 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02937012 (Efficacy and Security of Bezafibrate in Patients With Primary Biliary Cirrhosis Without Biochemical Response to Ursodeoxycholic Acid), which is not on this map. Cited by 80 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
80citing papers in PubMed, 7 pooled it
11.5field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02937012 phase3unknown statusnot on this mapstarted 2016, after this paper: background citation

Efficacy and Security of Bezafibrate in Patients With Primary Biliary Cirrhosis Without Biochemical Response to Ursodeoxycholic Acid: A Randomized, Double-blind, Placebo-controlled Trial

TypeinterventionalSponsorInstituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranRan2016 to 2019Enrolled34ConditionsPrimary Biliary CirrhosisArmsBezafibrate, Ursodeoxycholic Acid, Placebo (for Bezafibrate)
3 · Its place in the literature

Who cites it

80 citing papers in PubMed, 7 syntheses or guidelines pooled it, 199 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. [Ursodeoxycholic acid combined with bezafibrate in the treatment of refractory primary biliary cholangitis: a meta-analysis].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2019
    Pooled it
  6. Guideline
  7. Pooled it
  8. Trial
  9. Trial
  10. Trial
  11. Review
  12. Article
  13. Review
  14. Article
  15. Article
  16. The Efficacy and Safety of Seladelpar for Primary Biliary Cholangitis: A Systematic Review and Meta-Analysis.JGH open : an open access journal of gastroenterology and hepatology · 2025
    Review
  17. Review
  18. Review
  19. Review
  20. Review

20 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 4 institutions in 1 country.

Akira HondaDepartment of Gastroenterology, Tokyo Medical University Ibaraki Medical Center, Ami, Ibaraki, Japan.
Tadashi Ikegami
Makoto Nakamuta
Teruo Miyazaki
Junichi Iwamoto
Takeshi Hirayama
Yoshifumi Saito
Hajime Takikawa
Michio Imawari
Yasushi Matsuzaki
Tokyo Medical University Ibaraki Medical Center · JPNational Kyushu Medical Center · JPShowa University · JPTeikyo University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

unlabelledBezafibrate is a widely used hypolipidemic agent and is known as a ligand of the peroxisome proliferator-activated receptors (PPARs). Recently this agent has come to be recognized as a potential anticholestatic medicine for the treatment of primary biliary cirrhosis (PBC) that does not respond sufficiently to ursodeoxycholic acid (UDCA) monotherapy. The aim of this study was to explore the anticholestatic mechanisms of bezafibrate by analyzing serum lipid biomarkers in PBC patients and by cell-based enzymatic and gene expression assays. Nineteen patients with early-stage PBC and an incomplete biochemical response to UDCA (600 mg/day) monotherapy were treated with the same dose of UDCA plus bezafibrate (400 mg/day) for 3 months. In addition to the significant improvement of serum biliary enzymes, immunoglobulin M (IgM), cholesterol, and triglyceride concentrations in patients treated with bezafibrate, reduction of 7α-hydroxy-4-cholesten-3-one (C4), a marker of bile acid synthesis, and increase of 4β-hydroxycholesterol, a marker of CYP3A4/5 activity, were observed. In vitro experiments using human hepatoma cell lines demonstrated that bezafibrate controlled the target genes of PPARα, as well as those of the pregnane X receptor (PXR); down-regulating CYP7A1, CYP27A1, and sinusoidal Na(+) /taurocholate cotransporting polypeptide (NTCP), and up-regulating CYP3A4, canalicular multidrug resistance protein 3 (MDR3), MDR1, and multidrug resistance-associated protein 2 (MRP2).

conclusionBezafibrate is a dual PPARs/PXR agonist with potent anticholestatic efficacy in early-stage PBC patients with an incomplete biochemical response to UDCA monotherapy.

Indexed as

AdultAgedAged, 80 and overAnticholesteremic AgentsBezafibrateCarcinoma, HepatocellularCell Line, TumorCholagogues and CholereticsCytochrome P-450 CYP3ADrug Therapy, CombinationFemaleHumansLipidsLiverLiver Cirrhosis, BiliaryLiver NeoplasmsAnticholesteremic AgentsBezafibrateCholagogues and CholereticsCYP3A4 protein, humanCytochrome P-450 CYP3ALipidsPPAR alphaPregnane X ReceptorReceptors, SteroidUrsodeoxycholic Acid

Identifiers

PMID22911624
OpenAlexW2033362089

What OpenQuestion holds

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Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.