REAL-WORLD EFFECTIVENESS OF URSODEOXYCHOLIC ACID AND FIBRATES IN URUGUAYAN PATIENTS WITH PRIMARY BILIARY CHOLANGITIS

Introduction and Objectives

A considerable proportion of patients with primary biliary cholangitis (PBC) fail to achieve an adequate biochemical response to standard therapy with ursodeoxycholic acid (UDCA), which is associated with a poorer prognosis. This study aimed to evaluate the biochemical efficacy and tolerability of combining fibrates with UDCA in a cohort of Uruguayan patients with PBC.

Materials and Methods

A retrospective and descriptive cohort study was conducted. Adult patients with PBC who had persistently elevated alkaline phosphatase (ALP) levels after one year of UDCA treatment (13–15 mg/kg/day) and were subsequently treated with bezafibrate, fenofibrate, or ciprofibrate between 2018 and 2025 were included. Liver function tests were assessed at one and three months. The primary outcome was the ALP value at three months. Complete response was defined as normalization (ALP ≤ 1 × upper limit of normal [ULN]) and partial response as a reduction from baseline without normalization.

Results

Twenty patients (17 women, mean age 51.4 years) met inclusion criteria (see Table). Eleven patients received fenofibrate (160–200 mg/day), seven bezafibrate (200–400 mg/day), and two ciprofibrate (100 mg/day). Three patients discontinued fibrates before three months due to hepatotoxicity (ALTx5 ULN). Among the remaining 17 patients, eight achieved complete response, six showed partial improvement (24–76% improvement from baseline), and three had no biochemical change.

Conclusions

UDCA-fibrate combination therapy was associated with biochemical improvement in the majority of patients. However, the notable rate of hepatotoxicity warrants caution. Larger studies with extended follow-up are needed to validate these findings.

Conflict of interest: None

	Sex	Age at diagnosis	Cirrhosis	Type of Fibrate	ALP1 (ULN)	ALP2 (ULN)	ALP3 (ULN)	Response (%)
1	F	51	Yes	Fenofibrate	1.3	1.3	1.0	100
2	F	60	Yes	Fenofibrate	7.0	2.1	2.1	0.0
3	F	50	No	Fenofibrate	1.7	2.7	1.0	100
4	F	49	Yes	Fenofibrate	1.9	2.5	1.9	24.0
5	M	53	No	Bezafibrate	2.7	2.0	2.0	0.0
6	F	56	Yes	Fenofibrate	1.4	1.3	1.4	0.0
7	F	60	Yes	Fenofibrate	3.0	3.0	1.1	63.0
8	M	23	No	Ciprofibrate	4.5	4.6	1.4	69.0
9	F	43	Yes	Bezafibrate	2.27	4.1	1.5	63.0
10	F	58	No	Bezafibrate	2.1	2.1	0.7	100
11	F	44	Yes	Bezafibrate	5.5	3.6	0.9	100
12	F	51	No	Bezafibrate	1.2	1.2	1.0	100
13	F	57	No	Bezafibrate	4.8	4.8	0.4	100
14	F	67	No	Fenofibrate	6	6	4.7	21.8
15	F	55	No	Bezafibrate	1.97	1.52	0.9	100
16	F	48	Yes	Fenofibrate	2.4	2.4	-	-
17	F	51	No	Fenofibrate	1.36	1.36	-	-
18	F	49	No	Ciprofibrate	1.92	1.92	-	-
19	M	52	No	Fenofibrate	3.5	2.2	1	100
20	F	52	No	Fenofibrate	7.6	7.6	1.8	76

ALP1 (Alkaline phosphatase at one year of UDCA); ALP2 (Alkaline phosphatase prior to fibrate); ALP3 (Alkaline phosphatase three months into combined treatment)