P0052 - Fibrates as an Adjunct Therapy in Primary Biliary Cholangitis: A Propensity-Matched Analysis of Major Adverse Cardiovascular Events

Mohammad Alabbas, MD¹, Hussam Kawas, MD², Mohamad-Noor Abu-Hammour, MD³, Barish Eren, MD², Walid Hazem, DO⁴, Omar Sims, PhD⁵, Dian Jung Chiang, MD³
1Cleveland Clinic Foundation, South Euclid, OH; 2Cleveland Clinic Foundation, Cleveland, OH; 3Cleveland Clinic, Cleveland, OH; 4University Hospitals Cleveland Medical Center, Cleveland, OH; 5Cleveland Clinic Foundation, Hoover, AL

Introduction: Fibrates are a second line agents in the treatment of Primary Biliary Cholangitis (PBC). Even though fibrates have been shown to improve cholestatic enzymes in PBC, it is unclear whether fibrates confer additional cardiovascular benefit or risk in this population. To address this knowledge gap, we compared major adverse cardiovascular events (MACE) in a large propensity-matched PBC cohort treated with UDCA alone or with UDCA plus a fibrate in a large research database.

Methods: We performed a retrospective analysis using the TriNetX Research Network (104 U.S. healthcare organizations, 2005-2024). Adults with diagnosis of PBC receiving UDCA constituted the source population. Cohort A was also prescribed an additional fibrate (fenofibrate, gemfibrozil, bezafibrate, or ciprofibrate); Cohort B received UDCA monotherapy. One-to-one nearest-neighbor propensity-score matching balanced age, sex, diabetes, hypertension, baseline lipid panel, and other cardiovascular comorbidities, yielding 1,580 patients per cohort. The primary outcome was 5-year cumulative incidence of MACE, defined as acute myocardial infarction, acute heart failure, ischemic heart disease, or cerebral infarction. Secondary outcomes were the individual MACE components and all-cause mortality. Risks were expressed as risk ratios (RR) and 95 % confidence intervals (CI); time-to-event differences were assessed with Kaplan–Meier curves and hazard ratios (HR).

Results: The fibrate cohort had higher baseline total cholesterol (212.7 ± 90.0 vs 191.5 ± 66.7 mg/dL, p < 0.001) and triglycerides (165.6 ± 130.0 vs 121.4 ± 68.3 mg/dL, p < 0.001), but the two groups were well balanced on all other variables (all p-values > 0.05). Over a five-year period, fibrate and UCDA-only patients did not differ in the incidence of MACE (HR 1.09, 0.91-1.29, p = 0.35), no individual MACE components (all p-values > 0.05) , or all-cause mortality (HR 0.92, 0.73-1.16, p = 0.47).

Discussion: In this large U.S. real-world cohort, adding a fibrate to UDCA did not significantly increase MACE or mortality despite a more atherogenic lipid profile at baseline. The modest, nonsignificant excess in event rates likely reflects residual confounding from patients selected for fibrate therapy because of dyslipidemia. These real-world data suggests that fibrates is well-tolerated and without adverse major cardiovascular events as an adjunct therapy in PBC.

Disclosures:
Mohammad Alabbas indicated no relevant financial relationships.
Hussam Kawas indicated no relevant financial relationships.
Mohamad-Noor Abu-Hammour indicated no relevant financial relationships.
Barish Eren indicated no relevant financial relationships.
Walid Hazem indicated no relevant financial relationships.
Omar Sims indicated no relevant financial relationships.
Dian Jung Chiang: Ipsen – Advisory Committee/Board Member.

Mohammad Alabbas, MD¹, Hussam Kawas, MD², Mohamad-Noor Abu-Hammour, MD³, Barish Eren, MD², Walid Hazem, DO⁴, Omar Sims, PhD⁵, Dian Jung Chiang, MD³. P0052 - Fibrates as an Adjunct Therapy in Primary Biliary Cholangitis: A Propensity-Matched Analysis of Major Adverse Cardiovascular Events, ACG 2025 Annual Scientific Meeting Abstracts. Phoenix, AZ: American College of Gastroenterology.