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. 2025 Sep 26:S1933-2874(25)00419-2.
doi: 10.1016/j.jacl.2025.09.033. Online ahead of print.

Clinical implementation of bempedoic acid in blood lipid management: Real-world data from an Italian lipid clinic

Chiara Pavanello  1 , Giulia Cincotto  2 , Giuliana Germana Mombelli  3 , Sofia Castiglione  3 , Caterina Santolamazza  3 , Laura Calabresi  2 , Cesare Riccardo Sirtori  4 , Antonia Alberti  3
Affiliations
Free article

Clinical implementation of bempedoic acid in blood lipid management: Real-world data from an Italian lipid clinic

Chiara Pavanello et al. J Clin Lipidol. .
Free article

Abstract

Background: Bempedoic acid (BA), an ATP citrate lyase inhibitor, is approved for low-density lipoprotein (LDL)-cholesterol reduction and is well tolerated, especially in statin-intolerant patients. Real-world evidence, particularly from Europe, remains limited.

Objective: To assess real-world effectiveness, safety, and predictors of LDL-cholesterol target achievement with BA in Italian patients.

Methods: We conducted a retrospective observational study of 160 patients treated with BA at a lipid clinic in Milan, Italy. Patients were followed for 12 months. LDL-cholesterol levels, laboratory parameters, clinical events, and adverse effects were collected. Effectiveness was assessed as percentage change in LDL-cholesterol from baseline. Predictors of LDL-cholesterol target achievement were identified using multivariable logistic regression.

Results: BA significantly reduced LDL-cholesterol from 116.1 ± 49.3 to 78.5 ± 36.0 mg/dL (-26.1%, P < .05). The majority of patients (60.8%) reached European Society of Cardiology/European Atherosclerosis Society LDL-cholesterol goals (≤55 mg/dL). LDL-cholesterol reduction was greater in statin-intolerant patients (-29.0% vs -21.0%) and smaller in those with familial hypercholesterolemia (FH) (-18.0% vs -29.2%). Independent predictors of target non-achievement were FH (odds ratio [OR] 0.045, 95% CI 0.004-0.523, P = .013), while concomitant proprotein convertase subtilisin kexin type 9 inhibitor use predicted success (OR 31.82, 95% CI 2.57-394.17, P = .007). Among 69 patients not achieving LDL-cholesterol targets, 84% were on maximally tolerated lipid-lowering therapy (LLT), 67% were statin-intolerant, and 11 had FH. Safety analysis showed good tolerability; 4.0% developed hyperuricemia, and only 2 atherosclerotic cardiovascular disease events occurred during follow-up.

Conclusion: BA was effective and well tolerated in this high-risk cohort, including statin-intolerant and FH patients. Beyond its initial indication, BA now represents a valuable therapeutic option to optimize LDL-cholesterol lowering in patients who remain above target despite standard LLT.

Keywords: ASCVD risk; Bempedoic acid; Dyslipidemia; ESC/EAS target; Familial hypercholesterolemia; Real-word; Statin-intolerance.

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Conflict of interest statement

Declaration of competing interest CP, GC, SC, CS, LC, CRS declare that they have no conflict of interest with respect to this study. GGM and AA have served as investigators in trials supported by Daiichi Sankyo.