Effectiveness and Safety of Bempedoic Acid Plus Ezetimibe in Dyslipidemia: A Real-World Study

Objective: To evaluate the real-world effectiveness and safety of the fixed-dose combination of bempedoic acid 180 mg and ezetimibe 10 mg in adults with dyslipidemia. Methods: This retrospective, multicentric, observational study included 240 adults aged 18-65 years with dyslipidemia who received bempedoic acid 180 mg and ezetimibe 10 mg once daily for 12 weeks in routine clinical care. Demographic and clinical profile, concomitant therapies, lipid parameters, documented adverse events, and physician global assessments were extracted from available clinical records/eCRF data. Paired baseline and week 12 lipid values were compared using a paired t-test. Results: Mean age was 53.65 ± 7.05 years; 179 patients (74.58%) were male, and 61 patients (25.42%) were female. In the paired analysis (n=24), total cholesterol decreased from 207.71 ± 71.86 to 147.79 ± 51.94 mg/dL, LDL-cholesterol from 141.79 ± 37.77 to 87.92 ± 21.39 mg/dL, and triglycerides from 184.75 ± 96.01 to 117.96 ± 56.86 mg/dL (all p<0.001) at week 12. HDLcholesterol increased from 35.71 ± 5.98 to 38.83 ± 8.74 mg/dL (p=0.174) at week 12. No adverse events (AE), adverse drug reactions (ADR) and serious adverse events (SAE) were documented in the available records. Physician-rated effectiveness and tolerability were excellent or very good in 82.08% and 81.67% of patients, respectively. Conclusion: In this retrospective real-world study, bempedoic acid and ezetimibe were associated with substantial short-term improvement in triglycerides, total cholesterol, and LDL-C with favourable physician assessments. The results should be considered in the context of the limited paired lipid data, retrospective methodology, and absence of a comparator.