Evaluation of Real-World Treatment Outcomes Among Women 50 Years of Age and Older Who Were Treated With Statin + Ezetimibe or Statin Monotherapy in Italy and Belgium

OBJECTIVES: Reductions in low-density lipoprotein cholesterol (LDL-C) with statins and adjunct therapy (e.g. ezetimibe) are known to improve cardiovascular outcomes. However, real-world evidence (RWE) of add-on therapy remains scarce, especially among older women. We assessed goal attainment (based on 2021 European Society for Cardiology Guidelines) and change in LDL-C among women ≥50 years receiving combination therapy versus monotherapy in Italy and Belgium.

METHODS: In this retrospective analysis, electronic medical records data were obtained from The Health Intervention Network (THIN) database. The study populations were women ≥50 years receiving statin monotherapy or combination therapy from 2017 to 2020. The baseline period was 12-months before initial treatment with a follow-up of 12 months and at least 4 weeks of continuous treatment. Propensity score matching (PSM) was performed and relevant covariates were adjusted for in a multivariate regression analyses. Analyses were performed separately by country.

RESULTS: 104 (Italy) and 84 (Belgium) patients were analyzed following PSM. Those receiving combination therapy versus monotherapy were more likely to achieve goals [Italy:28.9% vs 13.5% respectively; odds ratio (OR):2.97, 95%CI:1.05-8.41; Belgium: 35.7% vs 16.7% respectively; OR: 2.92, 95%CI:1.02-8.34]. Age, CVD risk, statin intensity, and baseline LDL-C were not significantly associated with goal attainment. Patients receiving combination therapy had greater numerical LDL-C reductions in Italy (39.1% vs 30.5%, p=0.12) and Belgium (18.8% vs 9.1%; p=0.08) compared with monotherapy.

CONCLUSIONS: This RWE study revealed women ≥50 years of age were more likely to attain LDL-C goals with combination versus statin monotherapy, highlighting the need for proactive lipid management to achieve known CV benefits, given low overall goal attainment.