Efficacy and Safety of Bempedoic Acid Added to Standard Hypolipidemic Therapy on Lipid Target Achievement in High Risk Patients: Results in a Real World Setting

Background Bempedoic acid (BA) is approved for the reduction of LDL–C in addition to or instead of statin therapy and ezetimibe. Aim to assess impact of BA addition to statin therapy at the maximum tolerated dose and ezetimibe 10 mg on the achievement of therapeutic targets of LDL–C values in patient with previous acute coronary syndrome (ACS) and in follow up (FU) post–discharge. Methods The routine data of 195 patients (154 M/41 F) mean aged 60 ± 8 years, in FU after ACS, treated with usual lipid lowering therapy (LLT) (high efficacy statins at maximum tolerated dose and ezetimibe 10 mg) who did not reach the lipid target and BA was added at dose of 180 mg once daily, were analysed. All patients underwent lipid profile and creatine phosphokinase (CPK) dosage at baseline and at 12 months after the start of therapy. Renal and hepatic function was also assessed. The efficacy of the drug was assessed by the reduction in LDL–C at 12 months and compared to baseline. The results were compared to those observed before the addition of BA. Statistical Analysis Normally distributed variables are presented as mean ± standard deviation (SD) and were compared by Student’s t–test for paired data. A p≤0.05 value was considered statistically significant. Results the observation period lasted 19 ± 7 months. At 12 months, the LDL–C values ​​were 47,5±9,0 vs 62,9±5,7 mg/dL (p ‹0.001). These levels were maintained over time (in 38% of patients who continued FU beyond 12 months, in some cases with a maximum observation period of 30 months). Renal function assessed by estimated glomerular filtration rate did not change statistically significantly, from 58.12 ± 12,0 to 55,6 ± 14,7 mL/min per 1.73 m2 (P‹0.36). No statistically significant changes were observed in CPK values (p=NS). Significant changes were observed in uric acid values (5,2 ± 1,2 vs 6,2 ± 1,6 mg/dl – p ‹0.05) but were no clinically relevant. Conclusions The results of our analysis of aggregated data in the archive are in line with previously published clinical trials and confirm the effectiveness of bempedoic acid as additional LLT in a real–world setting. The average LDL–C reduction was highest among patients without LLT, and lower if bempedoic acid was added on to a pre–existing LLT.