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

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.