Real-world efficacy of bempedoic acid: early insights from the BEMPENET Italian Registry

Background/Introduction Bempedoic acid (BA), alone or combined with ezetimibe (E), is an oral lipid-lowering therapy option for patients who do not achieve LDL-cholesterol (LDL-C) targets or have limited statin tolerance. Real-world evidence on its efficacy across different background lipid-lowering therapy (LLT) regimens remains limited. Purpose BEMPENET is an Italian multicenter observational registry designed to evaluate the efficacy and safety of BA-based therapeutic strategies in routine clinical practice. This analysis assessed LDL-C percentage reduction at first follow-up according to concomitant LLT. Methods Consecutive patients initiating BA alone or in combination with E according to standard clinical practice were enrolled in the registry. The primary endpoint was median percentage change in LDL-C from baseline to follow-up. Results A total of 283 patients initiated a BA-based strategy (54.8% male, mean age 66.6±10.4 years) and were followed for a median time of 6.5 months. Of these patients, 68.2% had hypertension, 22.6% had type 2 diabetes mellitus, 32.5% had a previous acute coronary syndrome, 42% had chronic coronary syndrome, and 20.8% had peripheral atherosclerotic artery disease. Among enrolled patients, 132 started BA+E and 108 BA alone, on top of stable background LLT. Median LDL-C reduction was significantly higher in patients starting BA+E (34.5%, IQR 13.2; 47.1), compared to those on BA alone (20.1%, IQR 0.0; 39.4) (p=0.003). When stratifying by cardiovascular (CV) risk class, 85.4% of patients were at high or very high risk; in this cohort, BA+E achieved a significantly higher LDL-C reduction compared to BA alone (31.5% [IQR 8.7; 47.2] vs 19.6% [IQR 0; 38.6]; p=0.029). Among patients starting BA+E, LDL-C reduction was 30.8% (IQR 8.7; 43.5) in patients taking statins (n=68), compared to 40.4% (IQR 20.4; 49.5) in patients who did not (n=64). Among patients starting BA alone, LDL-C reduction was 18.3% (IQR -3.3; 38.3) in patients taking statins (n=69), compared to 32.3% (IQR 11.4; 44.8) in patients who did not (n=39). Additional 43 patients started BA+E (n=33) or BA (n=10) alone, concomitantly adding anti-Proprotein convertase subtilisin/kexin type-9 (PCSK9) therapy on top of stable background LLT. In this cohort, median LDL-C reduction was 58.7% (IQR 49; 69.3). Adherence was high in 95.1% of patients, partial in 1.4%, and poor in 3.5%. Conclusion(s) In this real-world experience, BA effectively reduced LDL-C, especially in patients not taking background statins and when associated with E and anti-PCSK9 therapy.