BEZURSO

11 evidence topics · 4 sources

Objective

Primary objective

“complete biochemical response” (opens the source at this quote in a new tab)

Location and study date

No evidence found.

Study design

Double-blind, placebo-controlled phase 3 design: duration

“24-month” (opens the source at this quote in a new tab)

Eligibility criteria

Inadequate UDCA response criterion

“Paris 2 criteria” (opens the source at this quote in a new tab)

Treatment

Bezafibrate daily dose in addition to UDCA

“400 mg” (opens the source at this quote in a new tab)

Study outcomes

Rationale for using complete biochemical response as the primary endpoint

Complete biochemical-response definition

“normal levels of total bilirubin, alkaline phosphatase, aminotransferases, and albumin” (opens the source at this quote in a new tab)

Additional primary-response criterion

“a normal prothrombin index” (opens the source at this quote in a new tab)

Biochemical-marker relevance

“Combining levels of alkaline phosphatase and bilirubin increased the ability to predict patient survival times.” (opens the source at this quote in a new tab)

Statistical analysis description

Number of participants (Planned and analyzed)

Randomized population

Treatment	Participants
Bezafibrate	“50”
Placebo	“50”

Description of analysis sets

No evidence found.

Results

Participant disposition

No evidence found.

Baseline characteristics

No evidence found.

Efficacy results

Month 24 biochemical results

Outcome	Bezafibrate	Placebo
Complete biochemical response	“31%”	“0%”
ALP normalization	“67%”	“2%”

Health-related quality of life and patient-reported outcomes

Safety results

Selected safety outcomes

Outcome	Bezafibrate	Placebo
Myalgia	“20%”	“10%”
Creatinine change from baseline: increase or decrease, respectively	“5%”	“3%”

Study limitations

Summary

This 100-participant comparator trial lasted 24 months and evaluated bezafibrate added to UDCA, not saroglitazar. Its complete biochemical-response definition differs from the EPICS-III composite, so the response percentages are not interchangeable across studies.